Does anchoring vaginal mesh increase the potential for correcting stress incontinence?

Does anchoring vaginal mesh increase the potential for correcting stress incontinence? Background: This study aims to explore the feasibility of anchoring a four-arm transvaginal mesh (TVM) to the mid- urethra to correct an anterior compartment POP–Quantification stage II–III (Q II–III) and concomitant genuine SUI. Methods: We analysed clinical data from 248 patients with stage II–III anterior prolapse and concomitant SUI who had undergone surgery at a tertiary referral centre in Hungary between January 2008 and June 2010. One hundred and twenty-four women treated with anterior colporrhaphy and 62 patients implanted with a conventional permanent TVM were selected as historical matched controls. Sixty-two patients received a modified permanent TVM, where the mesh was fixed to the mid-urethra with two stitches for the purpose of potentially correcting SUI. Surgical complications were classified using the Clavien–Dindo (CD) classification system. Results: The anti-SUI efficacy was minimally higher in the mTVM group than in the original TVM group (p = 0.44, 96.8% vs 91.9%, respectively), while prosthesis surgery was more effective than anterior colporrhaphy in improving the anterior compartment POP–Q status (96.8, 90.3% vs 64.5%, respectively). Anchoring the mesh did not increase the extrusion rate (p = 0.11). The de novo urge symptoms were not more prevalent among those who had received additional periurethral stitches (p = 1.00, 11.3% vs 12.9%). The incidence of reoperation observed in the mTVM group was non-significantly lower than that in the TVM group (p = 0.15, 6.5% vs 16.1%); however, the difference did not reach the level of significance. The early postoperative complication profile was more favourable among the mTVM patients (classified as CD I: 8.1%; CD II: 1.6%; and CD IIIb: 1.6%) as compared to the TVM group (p = 0.013). Conclusions: The new, modified mesh surgery represents an effective procedure for prolapse and concomitant SUI with a decreased risk of short- and long-term complications. Keywords: Modified transvaginal mesh, Transobturator tape, Anterior colporrhaphy, Complications, SUI with POP–QII, Clavien–Dindo classification Background view of the low recurrence rate (6.7–24%) [5–8] relative to Coexisting stress urinary incontinence (SUI) and pelvic that after classical anterior colporrhaphy (30–40%) [6, 8, 9]. organprolapse(POP) arehighlyprevalent (63–80%) [1], and A recent Cochrane review confirms the superiority of the cumulative risk of surgery for POP or SUI by the age of repairing prolapse of the mid-anterior vaginal wall with 80 years has been estimated at 11.1% [2, 3]. Despite the permanent mesh over native tissue repair [8]. However, a availability of a wide variety of prolapse surgery, there is no worldwide spread of a range of vaginal mesh operations has consensus on the optimal treatment. Vaginal prosthetic resulted in ahugenumberof complications (e.g.infection, surgery has been proposed foranteriorcompartment POP– extrusion and de novo urge symptoms). As a consequence, Quantification (Q) stage II–III (International Continence the US Food and Drug Administration has published Society/International Urogynecological Association) [4]in warnings with the aim of restricting the utilization of vaginal prosthesis to centres with specially trained surgeons after patients have been thoroughly informed [10]. Furthermore, * Correspondence: fekete.zoltan@med.u-szeged.hu Department of Urology, University of Szeged, Hungary, Semmelweis u. 1, it is assumed that a combination of a synthetic mesh with Szeged H-6725, Hungary the sling operation [11–13] will substantially increase the Department of Obstetrics and Gynaecology, University of Szeged, Hungary, cure rate of concomitant SUI. In contrast, the combined Semmelweis u. 1, Szeged H-6725, Hungary Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Fekete et al. BMC Urology (2018) 18:53 Page 2 of 11 techniques represent an increased complication rate and of Helsinki) for experiments involving humans and was elevated financial burden. approved by the Ethics Committee, Faculty of Medicine, It is well known that the supporting position of the University of Szeged (Protocol No. 194/2010). The prosthesis differs slightly with the transvaginal mesh Institutional Review Board supervised patient monitoring. (TVM) and transobturator tape (TVT-O). The TVT-O Written informed consent was obtained from all partici- sling is located under the mid-urethra, whereas the TVM pants after the advantages and possible complications of elevates the whole anterior and middle compartment [14]. the modified surgery were explained in detail. TVM produces a significantly weaker anti-SUI effect com- All the patients who exhibited coexisting symptoms pared to that of the TVT-O since TVM elevates the (both SUI and POP–QII–III) were recruited prospectively urinary bladder neck [7]. Furthermore, we hypothesise into the study. The symptomatic POP–Qstage II–III an- that the original TVM operation can be followed by terior prolapse is defined as the maximum extent of the residual SUI as the strengthening of the back arms may prolapsed anterior vaginal wall being within 1 cm above result in a backward sliding of the entire mesh, leading to and 6 cm below the hymen [4, 16]. According to the inter- alackofsuspension ofthe urethra. national POP guidelines (the EBU and NICE guidelines) We propose a modification of the four-arm TVM pro- [17, 18], if the condition disrupts the patient’slifeand cedure in an attempt to achieve a better SUI correction, nonsurgical treatment options have not helped, it should without any decrease in prolapse repair efficacy. We be treated surgically. POP repair was considered effective have developed a new method where the mesh is if a significant (> 1 cm) improvement was measured at sutured to the mid-urethra in order to prevent the back- points Aa, Ba and C and in total vaginal length (TVL) ward sliding, and, in this way, the anterior arms mainly during the follow-up in accordance with the POP–Q elevate the middle part of the urethra, potentially leading system (International Continence Society) [4, 16]. to effective anti-incontinence. In other words, the an- Anti-incontinence efficacy was determined if no further chored mesh takes over the function of the pubourethral SUI was diagnosed by urodynamic examination. ligament, which should normally stabilize the urethra, In all cases, urodynamic examinations comprising but is loose in SUI. uroflowmetry, cystometrography and abdominal leak We demonstrate an alternative operative method for point pressure tests were performed before surgery to POP–QII–III repair and anti-incontinence with the objectively determine the coexisting symptomatic SUI TVM fixed to the mid-urethra. The efficacy and short- based on the international guidelines (the EBU and and long-term complication profiles of this new surgical NICE guidelines) [15, 16]. The abdominal leak point technique were compared with those of historical con- pressure test was used as a standardised examination trols involving original TVM and anterior colporrhaphy method for the evaluation of SUI with urine leakage as a operations at our departments. sign. If the intraabdominal pressure recorded at the point of urine leakage was less than 40 cmH O, the Methods origin of the SUI was set as intrinsic sphincter deficiency The prospective longitudinal cohort study comprised 62 (ISD) [19]. In the case of ISD, preoperative pelvic floor women who presented for the correction of SUI in con- muscle training (PFMT) was recommended. If the junction with symptomatic anterior compartment POP–Q patient was unwilling to do PFMT or the training was II–III at the Departments of Urology and Obstetrics and unsuccessful, a modified TVM operation was recom- Gynaecology, University of Szeged, Hungary, between mended. This was also recommended in the case of sus- January 2010 and June 2010. The trial was conducted in pected urethral hypermobility – i.e. if the intraabdominal accordance with the IDEAL consensus. After the idea pressure at the point of urine leakage was higher than 60 (IDEAL stage 1) of concomitant surgery for SUI and POP cmH O. Preoperative irritating voiding symptoms were was developed, ten operations were performed with a high not an exclusion criterion before the study. cure rate of both symptoms in all cases after four weeks All the data were collected prospectively. Further in- (IDEAL stage 2). Based on these data, TVM or anterior clusion criteria in the study were negative urinary cultur- colporrhaphy and delayed TVT-O for SUI and coexisting ing and ineffective non-surgical treatment or patient’s POP repair have been replaced by the new surgery in our unwillingness to receive conservative treatment. The ex- departments (IDEAL stage 3) [15]. The patients were clusion criteria were as follows: occult SUI, a history of monitored during monthly outpatient appointments in mesh use or anti-incontinence pelvic procedures, anti- the first six months; thereafter, check-ups occurred every depressant therapy, pregnancy, whether the patient was half year. The Institutional Review Board regularly in the puerperal period and up to six months reviewed the clinical data on the patients. post-partum, and cancer of the pelvic organs. Our work was carried out in accordance with the Code There are no clear international recommendations on of Ethics of the World Medical Association (Declaration surgical anterior compartment POP–Q II repair, but an Fekete et al. BMC Urology (2018) 18:53 Page 3 of 11 increasing body of evidence suggests that TVM is a bet- ter treatment option for anterior wall prolapse ≥ stage II than traditional anterior colporrhaphy [7, 20, 21]. We have modified the transobturator TVM operation re- ported by Sergent et al. [7] by inserting two additional stabilizing sutures which fix the anterior edge of the mesh to the paraurethral tissues at the level of the mid-urethra. All operations were carried out with 100% polypropylene monofilament permanent meshes pro- duced by Aspide® SURGIMESH® PROLAPSE (Aspide Médical, La Talaudière, France). The implanted vaginal prosthesis has pores which are 1.6 × 1.7 mm in size and is approved for anterior vaginal repair. Surgery was performed under general anaesthesia with the patient in the lithotomy position with an indwelling urinary catheter. The anterior vaginal wall was incised longitudinally throughout its thickness from the cervix to 1 cm below the urethral meatus, under the mid-ure- Fig. 1 Anchoring stitches stabilize the mesh position under the mid-urethra thra. The thickness of the dissection, the location of the vaginal incision, the placement of the mesh and the closure of the incision varied only minimally, and the The historical controls comprised 62 patients with length of the incision varied only between 6 and 7 cm. genuine SUI verified by urodynamic examination with Before insertion, all sterile meshes were soaked in iodic grades of POP II–III who had originally undergone a fluid (Betadine®). The Surgimesh® device was introduced TVM operation (control group I). A further 124 patients beneath the dissection. Its four arms were then passed with anterior compartment symptomatic POP–Q II and through the obturator membrane. The posterior part of any SUI corrected by anterior colporrhaphy operations the mesh was anchored to the anterior side of the (control group II) were also operated on by the same cervix using two Prolene® 2–0sutures (Ethicon, two senior surgeons at the departments. The data on the Issy-les-Moulineaux, France). historical controls were retrieved retrospectively from The mesh was then spread by securing its anterior the medical database between January 2008 and December parts beneath the mid-urethra using two Vicryl 2–0® 2009. Eligibility for the operation and consistent collection absorbable sutures (Ethicon, Issy-les-Moulineaux, of outcome measurements (operative characteristics and France) and promoting the proper elevation and closure post-operative findings) were tied to a follow-up schedule of the urethra (Fig. 1). The mesh was then adjusted in a which was routinely established in the historical groups. tension-free manner beneath the distal part of the This schedule was followed for the mTVM group as well. urethra and bladder, and the anterior vaginal wall was The follow-up period in the control groups was also three closed using Monocryl® 3–0 absorbable sutures (Ethicon, years. Baseline and follow-up evaluations after six weeks to Issy-les-Moulineaux, France) with a slight colpectomy. three years were performed by an experienced urogynaecol- All the operations were performed by the same two ogist. All the patients were given an appointment for the experienced senior surgeons, and there were no dif- subsequent medical consultation according to a follow-up ferences in the operative processes. arrangement (Table 1). When a patient missed an appoint- Prophylactic preoperative antibiotics (cefazolin 1 g, ment, a urogynaecologist reminded her by telephone, and, amoxicillin and clavulanic acid 1.2 g or gentamycin hence, there was no registered loss due to lack of follow-up 160 mg) were administered intravenously. A urinary in our samples. For each case, we matched controls in each catheter was removed on the morning of the postoperative control arm (groups I and II) who were as similar as day. A vaginal gauze pack (gauze soaked in Betadine possible in age, systemic diseases, and previous parity and iodine) was placed for 12 h. The post-voided residual urine vaginal operations. was measured by ultrasonography before each patient was The factors studied were the demographic and patient discharged. All the patients participated in topical intravagi- data, the intraoperative findings and postoperative nal oestrogen cream treatment for at least twelve months factors. Furthermore, the incidence of systemic chronic following the operation (Ovestin® 1 mg/gram daily), but diseases that might have a detrimental effect on the none of the patients took part in preoperative oral hormone healing process (i.e. in diabetes mellitus and auto- replacement therapy. The follow-up period after the modi- immune diseases) was also recorded, and displacement fied TVM operation was 36 months. of the implant due to chronic coughing in airway Fekete et al. BMC Urology (2018) 18:53 Page 4 of 11 Table 1 Schedule of assessments/data collection for both Assessment Recruitment before Intervention Follow-up intervention phase (Surgery) 6 weeks 6 months 1 years 2 years 3 years Written informed consent x Gynaecological examination: incontinence symptoms x x X x x x X Gynaecological examination: prolapse x x X x x x X Urodynamic examination x x X Adverse events x X x x x X Urine culture x x x x X available in the modified transvaginal mesh operated women diseases was also considered. As concerns the long-term the odds for continuous variables. Multiple logistic regres- postoperative complications of the sling and mesh pro- sion was used to adjust the comparisons of the groups in cedures, we determined the rejection rate, the presence terms of age, previous parity, postmenopausal stage, previ- of de novo urge symptoms (DNUS) or urinary tract ous vaginal operations, chronic systemic diseases, POP–Q infection (UTI), and the need for reoperation. The stage and urge symptoms due to inequalities between diagnosis of DNUS was set if detrusor pressure changes cases and controls. A two-tailed p-value of < 0.05 was were detected in cystometrographic pressures after the judged as significant. The power of the statistical tests surgeries. The postoperative complications that led to ranged between 74 and 99% in the study. reoperation were infection, recurrent descent or incon- tinence, implant extrusion, chronic pelvic pain and total Results retention. Prosthetic extrusion was diagnosed by the Table 2 presents the baseline characteristics of the par- presence of exposed graft material in the vagina. ticipants in the study groups. Maternal age and BMI Post-void residual urine is a measurement of the urine were significantly higher among the mesh-operated that remains in the bladder less than 20 min following patients (p < 0.001 and p = 0.004, respectively). The vast voiding which identifies urinary retention. Bladder majority was postmenopausal in all groups; however, the volumes that suggest urinary retention are commonly highest rate was noticed disproportionally among those defined as greater than 500 to 600 ml [22, 23]. DNUS who had undergone mTVM (97%). was classified as a sudden involuntary contraction of the There was a trend of patients with modified mesh muscular wall of the bladder causing urinary urgency, an having vaginal deliveries and vaginal operations at the immediate unstoppable urge to urinate with a postopera- highest rate; however, the differences between the tive onset. groups were not significant. No significant differences Operative and perioperative complications (six weeks were observed between groups in any type of chronic after the procedures) described after mTVM and systemic diseases. historical operations were collated, overall frequency Table 3 lists the operative characteristics and compli- within all cases were calculated, and severity was graded cations, while Table 4 provides the odds and adjusted using the Clavien–Dindo classification comprising all odds of the differences in baseline and surgical charac- the follow-up periods. More specifically, additional teristics in the three study groups. The operation took a medication due to deviation from the normal postopera- similar amount of time in the mTVM group as com- tive course (pain, fever, wound infection and minimal pared with the anterior colporrhaphy (Adjusted odds bleeding) was categorized as Grade I, UTIs requiring rate (AOR): 1.03) or TVM (AOR: 0.97) control group. antibiotic treatment and SUI/POP without any postoper- The estimated blood loss during the operation was ative correction, DNUS or blood transfusion were significantly lower in the mTVM group than in control grouped as Grade II, and reoperation performed in group I (AOR: 0.96, p < 0.001) and control group II general anaesthesia was graded as IIIb [22]. (AOR: 0.96, p < 0.001). The occurrence of bladder injury and the need for immediate postoperative blood transfu- Statistical analysis sion were negligible in all the study groups. The SPSS 17.0 program package was used to analyse the The reoperation rate was significantly the lowest in the data. The non-parametric design of the continuous mTVM group at 6.5% as compared to that in the anterior variables was verified with the Shapiro–Wilk test. The colporrhaphy group (32.1%) (AOR: 0.07, p < 0.001) and categorical and continuous variables were compared that of 16.1% in the TVM group (AOR: 0.22, p =0.15). with the χ test and Kruskal–Wallis test, respectively. The rate of implant removal was lower among those Univariate logistic regression was employed to determine mesh-operated patients who had undergone the modified Fekete et al. BMC Urology (2018) 18:53 Page 5 of 11 Table 2 Baseline characteristics of patients who presented for operation for POP–QII–III and genuine SUI between January 2006 and December 2012 Modified TVM group Control group I Control group II (historical controls: p value (N = 62) (historical controls: TVM) (N = 62) anterior colporrhaphy) (N = 124) Age (y) (mean ± S.D.) 62.9 ± 7.7 59.7 ± 10.1 55.9 ± 11.1 < 0.001 BMI (kg/m ) (mean ± S.D.) 29.4 ± 2.9 28.4 ± 3.0 27.8 ± 3.8 0.004 Previous vaginal deliveries (mean ± S.D.) 2.3 ± 1.2 2.1 ± 0.6 2.1 ± 0.8 0.71 Postmenopausal women, n (%) 60 (96.8) 47(75.8) 92 (74.2) 0.001 Previous vaginal operations, n (%) 24 (38.7) 14 (22.6) 36 (29.0) 0.14 Chronic systemic diseases, n (%) 17 (27.4) 16 (25.8) 18 (14.5) 0.06 Diabetes mellitus, n (%) 10 (16.1) 10 (16.1) 9 (7.3) 0.09 Autoimmune diseases, n (%) 4 (6.5) 3 (4.8) 5 (4.0) 0.77 Airway diseases, n (%) 5 (8.1) 3 (4.8) 6 (4.8) 0.64 All recruited patients presented for anterior compartment POP–QII–III (pelvic organ prolapse) and genuine SUI (stress urinary incontinence). The modified transvaginal mesh (mTVM) group comprised patients who received a four–arm mesh that was fixed to the mid-urethra. Control groups I and II include historical controls who had participated in TVM and anterior colporrhaphy without any Kelly–Stoeckel suture, respectively Chronic systemic diseases include diabetes mellitus, airway diseases and autoimmune diseases technique than those with the original TVM (AOR: 0.13, operation. All implants were removed because of the 1.6% vs 9.7%, respectively); however, the difference did not extrusion of the vaginal wall. No rectal or bladder reach a significant level. One reoperation occurred in the fistula, pelvic abscess or haematoma was observed in mTVM group due to apical compartment POP (1.6%), an- any of the groups. other (1.6%) was performed due to anterior compartment Modifying the TVM technique led to a signicantly descent after the removal of the extruded mesh, a third higher elevation of point Aa compared to the traditional (1.6%) for SUI and a fourth (1.6%) for postoperative pain. TVM (AOR: 4.83) with a significantly reduced shorten- In addition, reoperation due to postoperative POP had a ing of the vagina (AOR: 0.41). The mTVM significantly frequency of 8.1%, and one patient (1.6%) required improved the prolapse status (POP–Q of Aa, AOR: reoperation due to SUI in the original TVM group. The 142.9; Ba, AOR: 5.95; and C, AOR: 25.0) compared to colporrhaphy patients needed more reoperations (32.1%), that of anterior colporrhaphy, whereas the total vaginal and the difference was robust (AOR: 0.007). All the cases length was significantly shortened (p < 0.001) (Table 5). involving POP recurrence (3.2 and 9.7%, AOR: 2.94) follow- Table 6 demonstrates the postoperative complications ing the two mesh operations were found in the untreated within six weeks according to the Clavien–Dindo classi- compartment, posteriorly behind the mesh-supported area. fication. A total complication rate of 11.3% in the The recurrence of anterior compartment POP (35.5%, mTVM group, 35.5% in the TVM group and 22.6% in p < 0.001) and SUI (38.7%, p < 0.001) or reoperation the colporrhaphy group was noted with significant differ- duetorecurrenceof SUI (8.9%, AOR: 0.11, p = 0.06) ences (p = 0.013). Subanalyses were performed indicating and POP (25.0%, AOR: 0.05, p < 0.001) during the that the complications occurred with a non-significantly follow-up period was typical of the anterior colporrha- lower prevalence among the mTVM participants phy patients. As expected, slightly more cases of SUI compared to the anterior colporrhaphy group (AOR: 0.56, were cured in the mTVM group than in the TVM p = 0.3), whereas the difference was significantly lower in group (96.8% vs 91.9%), although the differences were the mTVM group than among the TVM participants not significant (AOR: 2.98). Prolapse repair was (AOR: 0.29, p = 0.02) (data are not shown). CD I compli- achieved in a significantly higher proportion of the cations predominantly occurred in the two groups of patients who underwent mTVM compared to their women operated on with prostheses, whereas the anterior colporrhaphy counterparts (96.8% vs 64.5%, historical anterior colporrhaphy operations were followed AOR: 14.16 p < 0.001). Modification of the TVM mostly by CD II. displayed a moderate effect on POP recurrence compared to the original operation (9.7%) (AOR: 2.94, Discussion p = 0.27). Urinary tract infection was not more preva- The most striking result of this study is that the transva- lent after the prosthesis operations than after anterior ginal implantation of the four-arm mesh sutured to the colporrhaphy. The rate of extrusion was nearly four mid-urethra, a new modification of the TVM procedure times higher in the TVM group than in the mTVM [7], is highly effective in the repair of an anterior group (AOR: 0.13, p = 0.11), with extrusion appearing prolapse (POP–QII–III) and in genuine stress urinary earlier in the group that underwent a non-modified incontinence (SUI). Success rates of 96.8 and 96.8% were Fekete et al. BMC Urology (2018) 18:53 Page 6 of 11 Table 3 Operative characteristics and postoperative complications of patients who presented for operation for POP–QII–III and genuine SUI between January 2006 and December 2012 Modified TVM Control group I (historical Control group II (historical controls: p value group (N = 62) controls: TVM) (N = 62) anterior colporrhaphy) (N = 124) POP grading grade II 50 (80.6) 59 (95.2) 124 (100) < 0.001 grade III 12 (19.4) 3 (4.8) 0 (0) Urge symptoms 8 (12.9) 2 (3.2) 7 (5.6) 0.08 Duration of operation (min) (mean ± S.D.) 37.8 ± 7.4 38.8 ± 6.0 34.9 ± 7.9 < 0.001 Estimated blood loss (ml) (mean ± S.D.) 48.7 ± 21.8 83.8 ± 41.2 74.0 ± 33.4 < 0.001 Intraoperative bladder injury, n (%) 1 (1.6) 0 (0) 0 (0) 0.22 Blood transfusion, n (%) 0 (0) 0 (0) 1 (0.8) 0.61 Reoperation, n (%) 4 (6.5) 10 (16.1) 40 (32.3) < 0.001 POP–Q, n (%) 2 (3.2) 5 (8.1) 31 (25.0) < 0.001 SUI, n (%) 1 (1.6) 1 (1.6) 11 (8.9) 0.04 Vaginal wall extrusion, n (%) 1 (1.6) 6 (9.7) 0 (0) 0.11 Postoperative bleeding, n (%) 0 (0) 3 (4.8) 1 (0.8) 0.06 Postoperative pain, n (%) 1 (1.6) 0 (0) 0 (0) 0.22 Total retention, n (%) 0 (0) 1 (1.6) 1 (0.8) 0.61 Successful treatment of POP–Q, n (%) 60 (96.8) 56 (90.3) 80 (64.5) < 0.001 Successful treatment of SUI, n (%) 60 (96.8) 47 (75.8) 76 (61.3) < 0.001 Urinary tract infection, n (%) 11 (17.7) 14 (22.6) 23 (18.5) 0.75 De novo urge incontinence, n (%) 7 (11.3) 8 (12.9) 0 (0) < 0.001 Average time to observed extrusion (months) (mean ± S.D.) 1 ± 0 13.7 ± 8.3 n.m. 0.13 All recruited patients presented for anterior compartment POP–QII–III (pelvic organ prolapse) and genuine SUI (stress urinary incontinence). The modified transvaginal mesh (mTVM) group comprised patients who received a four–arm mesh that was fixed to the mid-urethra. Control groups I and II include historical controls who participated in TVM and anterior colporrhaphy without any Kelly–Stoeckel suture, respectively. n.m. , not measurable demonstrated for genuine SUI and prolapse, respectively. mid-urethra, where the pubourethral ligament originally This surgical procedure for prosthetic placement pro- held it, helps to elevate the middle region, this being con- vided a minimally better SUI reconstructive effect than sidered the treatment of SUI that is at least as effective as that of the TVM procedure in our historical control the TVT-O technique (91.2% in our non-published data group (91.9%) or that reported in the literature (69–90.3%) and 92% in the literature) [30]. In other words, anchoring [24–26]. With regard to the POP repair, mTVM (96.8%) the anterior part of the mesh to the mid-urethra imitates proved significantly more effective than historical anterior the mechanism of action of the mid-urethral sling as an colporrhaphy (64.5%), but only minimally higher than that additional procedure for SUI correction. The original of the non-modified, transobturator mesh technique in our TVM has a limited anti-SUI mechanism. database (90.3%) and that demonstrated in the literature Furthermore, our results suggest a better anatomical (with a rate of 82.3–100%) [5, 20, 21, 26–29]. Fixing the success rate after the mesh is fixed to the mid-urethra, anterior arm of the mesh to the periurethral tissue elevates which may be explained by the lack of shrinkage and less point Aa significantly more effectively than the original folding of the mesh. By contrast, our results might allow TVM with less vaginal shortening. for the speculation that prosthesis stabilization with TVM supports the whole of the anterior and middle sutures to prevent any backward movement could lead compartments, but does not elevate the middle of the to prolapse recurrence in the untreated middle com- urethra and, hence, theoretically allows for urethral partment, i.e. in the area not supported by the mesh. dorsal rotation, which may lead to residual SUI, We attribute our lower anatomical recurrence of especially if the mesh is able to migrate a bit more pos- mTVM to a wider suspension area of the insertion of a teriorly toward the cervix. It is also possible that mesh smooth, non-folded mesh. To check on this, we have movements could be responsible for DNUS with the launched a further study at our department, in which traditional TVM method. Using stabilizing sutures to fix the posterior arms of the TVM are anchored towards the mesh to the paraurethral tissues at the level of the the pericervical ring to provide apical support. Fekete et al. BMC Urology (2018) 18:53 Page 7 of 11 Table 4 Crude odds ratios (OR) and adjusted OR (AOR) for confounders in various comparisons of patients who presented for operation for POP–QII–III and genuine SUI between January 2006 and December 2012 Modified TVM group vs Control group I Modified TVM group vs Control group II (historical controls: TVM) (historical controls: anterior colporrhaphy) a a p value Unadjusted OR Adjusted OR p value Unadjusted OR Adjusted OR (95% CI) (95% CI) (95% CI) (95% CI) Age 0.05 1.04 (1.00–1.08) 1.02 (0.97–1.08) < 0.001 1.07 (1.04–1.11) 1.05 (1.01–1.10) BMI 0.05 1.13 (1.00–1.29) 1.12 (0.96–1.30) 0.001 1.14 (1.04–1.25) 1.13 (1.01–1.26) Previous vaginal deliveries 0.26 1.28 (0.83–1.98) 1.57 (0.90–2.76) 0.45 1.15 (0.84–1.58) 1.18 (0.79–1.76) Postmenopausal women 0.001 9.6 (2.09–4.35) 11.58 (1.78–75.1) < 0.001 10.44 (2.41–45.2) 8.09 (0.98–67.05) Previous vaginal operations 0.08 2.16 (0.99–4.74) 2.16 (0.86–5.44) 0.19 1.54 (0.81–2.93) 1.29 (0.59–2.80) Chronic systemic diseases 1.00 1.09 (0.49–1.41) 0.95 (0.37–2.41) 0.045 2.23 (1.05–4.71) 1.84 (0.77–4.41) Diabetes mellitus 1.00 1.00 (0.38–2.60) 0.77 (0.16–4.46) 0.07 2.46 (0.94–6.11) 0.86 (0.19–3.88) Autoimmune diseases 1.00 1.36 (0.29–6.33) 3.23 (0.41–25.67) 0.48 1.64 (0.43–0.34) 1.99 (0.34–11.59) Airway disorders 0.72 1.72 (0.40–2.58) 0.90 (0.15–5.54) 0.51 1.73 (0.51–5.89) 0.4 (0.08–2.14) POP–Q III vs II 0.02 4.71 (1.26–17.5) 6.32 (1.07–37.52) < 0.001 1.24 (1.10–4.40) 1.36 (1.08–4.10) Urge symptoms 0.09 4.44 (0.90–21.74) 4.85 (0.91–25.94) 0.10 2.48 (0.85–7.18) 3.02 (0.84–10.90) Duration of operation 0.41 0.98 (0.93–1.03) 0.97 (0.91–1.03) 0.22 1.05 (1.01–1.09) 1.03 (0.98–1.09) Estimated average blood loss < 0.001 0.96 (0.95–0.98) 0.96 (0.94–0.98) < 0.001 0.96 (0.94–0.97) 0.96 (0.94–0.98) b b b Intraoperative bladder injury 1.00 1.02 (0.98–1.05) n.m. 0.33 1.02 (0.99–1.05) n.m. b b b b Blood transfusion n.m n.m n.m. 1.00 0.99 (0.98–1.01) n.m. Reoperation 0.15 0.36 (0.11–1.21) 0.22 (0.04–1.10) < 0.001 0.15 (005–0.43) 0.07 (0.02–0.32) POP 0.44 0.38 (0.07–2.04) 0.26 (0.04–1.96) < 0.001 0.10 (0.02–0.43) 0.05 (0.006–0.41) SUI 1.00 1.00 (0.06–16.39) 0.19 (0.01–5.7) 0.06 0.17 (0.02–1.34) 0.11 (0.06–0.89) b b Vaginal wall extrusion 0.11 0.15 (0.02–1.31) 0.13 (0.009–1.71) n.m n.m. n.m. Bleeding 0.24 0.95 (0.90–1.01) n.m. 1.00 0.99 (0.98–1.01) 0.89 (0.68–1.12) b b Postoperative pain 1.00 1.02 (0.98–1.05) n.m. 0.33 1.02 (0.99–1.05) n.m. b b Total retention 1.00 0.98 (0.95–1.02) n.m. 1.00 0.99 (0.98–1.01) n.m. Successful treatment of POP–Q 0.27 3.22 (0.62–16.67) 2.94 (0.47–18.6) < 0001 16.5 (3.85–70.77) 14.16 (3.09–65.00) Successful treatment of SUI 0.004 9.58 (2.09–43.9) 72.2 (8.56–606.65) < 0.001 18.95 (4.43–81.13) 96.2 (7.40–1250.0) Urinary tract infection 0.66 0.74 (0.31–1.79) 0.70 (0.26–1.87) 1.00 1.95 (0.43–2.19) 0.92 (0.34–2.45) De novo urge symptoms 1.00 0.86 (0.29–2.53) 0.89 (0.25–3.22) < 0.001 1.13 (1.03–1.23) 1.10 (1.06–1.19) b b b b b Average time to extrusion observed 0.99 n.m. n.m. n.m. n.m. n.m. All recruited patients presented for anterior compartment POP–QII–III (pelvic organ prolapse) and genuine SUI (stress urinary incontinence). The modified transvaginal mesh (mTVM) group comprised patients who received a four–arm mesh that was fixed to the mid-urethra. Control groups I and II include historical controls who participated in TVM and anterior colporrhaphy without any Kelly–Stoeckel suture, respectively OR, Odds ratio; 95% CI, 95% confidence interval, Adjusted OR , All variables were adjusted for age, previous parity, postmenopausal stage, previous vaginal operations and chronic systemic diseases, POP–Q stage and urge symptoms. n.m. , not measurable TVM corrects SUI subjectively in only 83.3% of cases mid-urethral sling in one session has been scarcely studied [7]. Furthermore, subvesical mesh towards the obturator [12, 32]. When TVM was combined with a TVT-O oper- spaces in a total of 74 patients with a stage ≥2 anterior ation [12, 32], the success rate for SUI was 87.8–93.2% prolapse was associated with a symptomatic SUI repair and that for anterior wall repositioning was 94.4–96%, i.e. in 72% of the cases, and cystocele was corrected in 97% a similar anti-incontinence and anatomical reconstruction [27]. The current trend is to resolve the concomitant rate than those in our study, though that follow-up was SUI and POP in a single hospitalization session so as to for up to 60 months. More studies are needed to evaluate reduce medical costs and improve the patient’s satisfac- whether the additional insertion of a TVT-O sling into a tion, but the optimum use of anti-incontinence proce- mesh provides any additional improvement in the SUI dures during pelvic reconstructive surgery remains a and POP cure rate as compared with a single TVM or matter of debate [31]. A combination of mesh with a modified TVM. Fekete et al. BMC Urology (2018) 18:53 Page 8 of 11 Table 5 Patients’ preoperative and postoperative POP-Q status Control group I (historical controls: TVM) p value Unadjasted Adjusted Modified TVM group p value Unadjasted Adjusted OR Control group II (historical controls: (N = 62) OR (95% CI) OR (95% CI) (N = 62) OR (95% CI) (95% CI) anterior colporrhaphy) (N = 124) Pre-operative Post-operative Mean difference Pre-operative Post-operative Mean difference Pre-operative Post-operative Mean difference Aa −0.97 ± 0.6 −1.37 ± 0.55 −0.40 ± 0.61 < 0.001 4.55 4.83 − 0.55 ± 0.69 − 1.68 ± 0.74 − 1.13 ± 0.80 < 0.001 43.5 142.9 −0.97 ± 0.36 − 0.76 ± 0.69 0.21 ± 0.60 (2.38–9.09) (2.26–10.31)0.6 (1.61–125) (28.57–500.0) Ba −0.42 ± 0.64 − 1.74 ± 1.0 −2.16 ± 1.04 0.50 1.12 1.17(0.71–1.52) −0.53 ± 1.08 −1.76 ± 0.94 −2.3 ± 1.08 < 0.001 6.49 5.95 − 0.49 ± 0.75 − 0.94 ± 1.48 − (0.8–1.56) (3.65–11.63) (3.27–10.87) 0.45 ± 1.17 C −6.55 ± 1.16 −6.82 ± 0.85 −0.27 ± 0.6 0.70 0.90 1.20(0.66–2.16) − 6.53 ± 0.82 − 6.76 ± 0.67 − 0.23 ± 0.58 < 0.001 23.81 25.0 − 6.74 ± 0.61 − 6.45 ± 0.83 0.29 ± 0.62 (0.54–1.52) (3.34–166.67) (3.70–166.7) b b TVL 8.25 ± 0.67 7.9 ± 0.62 −0.35 ± 0.48 0.018 0.37 0.41(0.16–0.99) 7.82 ± 0.42 7.66 ± 0.60 −0.16 ± 0.41 < 0.001 n.m. n.m. 7.91 ± 0.29 7.91 ± 0.29 0.0 ± 0.0 (0.16–0.86) All recruited patients presented for anterior compartment POP–QII–III (pelvic organ prolapse) and genuine SUI (stress urinary incontinence). The modified transvaginal mesh (mTVM) group comprised patients who received a four–arm mesh that was fixed to the mid-urethra. Control groups I and II include historical controls who participated in TVM and anterior colporrhaphy without any Kelly–Stoeckel suture, respectively OR, Odds ratio; 95% CI, 95% confidence interval, a b Adjusted OR , All variables were adjusted for age, previous parity, postmenopausal stage, previous vaginal operations and chronic systemic diseases, POP–Q stage and urge symptoms. n.m. , not measurable Fekete et al. BMC Urology (2018) 18:53 Page 9 of 11 Table 6 Clavien–Dindo classification for postoperative surgical complications among patients who presented for operation for POP–QII–III and genuine SUI between January 2006 and December 2012 Clavien–Dindo Complications Modified TVM group Control group I Control group II p value grade (N = 62) (historical controls: TVM) (historical controls: anterior colporrhaphy) (N = 62) (N = 124) I Non–pharmacologically 5 (8.1) 12 (19.4) 11 (8.9) 0.013 treated postoperative bleeding, fever, wound infection II Urinary tract infection, 1 (1.6) 7 (11.3) 16 (12.9) post–void residual volume, blood transfusion, treatment for de novo urge symptoms IIIb Reoperation for 1 (1.6) 3 (4.8) 1 (0.8) vaginal wall extrusion Total complications 7 (11.3) 22 (35.5%) 28 (22.6) 0.015 a b CD, Clavien–Dindo. No grade IIIa, IVa, IVb or V complication occurred. Data are expressed as n (%) Surprisingly, the double-sling extrusion rate was ex- was much higher than in our mTVM data series tremely low (0–10%) [12, 32]. The corresponding figures (48.7 ml), and the mean procedure duration was also were 1.6% in our mTVM group and 9.7% among our shorter in the mTVM group (37.8 min vs. 60.9 min) TVM participants, which is in agreement with the mean [36]. value of 11.6% (ranging from 3.9 to 16%) reported in the One of the most frequent long-term complications we literature [4, 20, 24, 27, 33, 34]. The extrusion rate observed with synthetic mesh materials in our series was generally correlates well with the prosthesis breadth; DNUS (11.3% and 12.9), which is an important indicator however, we observed a remarkably higher extrusion rate of the level of patient satisfaction. Post-operative urody- for mesh compared to that for modified mesh. One can namic examinations showed detrusor muscle action in speculate that the lack of stabilizing sutures led to a all the cases suffering from DNUS. The average detrusor “folding/wrinkling” of the edge of the mesh, resulting in muscle pressure was 7.75 cmH O postoperatively, a lifting up and compressing of the mucosa and whereas no sign of detrusor or intravesical pressure ele- deranged periprosthetic vasculature. The reported inci- vation was detected preoperatively. We believe that one dence of prosthesis exposure for double-sling operations possible reason for this is the fact that the mesh cannot is not clear-cut. A wider and double prosthesis involves slide backwards and cannot press the urethra to the a greater chance of bacterial colonization, and the bladder neck after the TVM is modified. The average enhanced preparation may additionally impair blood reported prevalence of de novo dyspareunia following supply to the vaginal wall. vaginal placement of a polypropylene mesh is 14% [37], Anterior colporrhaphy is inferior to mesh procedures i.e. significantly higher than in our study (1.6%) (the data with regard to the effectiveness of POP repair and are not presented in a table). Mesh+sling operations anti-incontinence both in our database and as reported by impair the pelvic blood circulation and induce de novo others (37–85 and 54%, respectively) [20, 33, 35, 36]. The urge symptoms and pelvic pain; however, the reported mTVM greatly improved the POP–Q status in all exam- extrusion rate was 10% [32]. ined compartments in the vagina compared to that of col- Our study had some limitations. The baseline charac- porrhaphy. However, the perioperative complication rate teristics of the patients were not equally distributed in is diminished after non-mesh surgery (22.6%) compared the groups, and, hence, statistical adjustments were used to that after implant surgery (35.5%). This is supported by in multivariate analyses. A further limitation of the study the literature data [20, 28, 35]; however, our modified is its non-randomized manner. The surgeons became mesh procedure produced the lowest complication rate in better trained in the operative techniques, a fact which our dataset (11.3%). The robustly lower complication rate may somehow bias the results. Moreover, it was not an after the mTVM can be partly explained by the fact that aim of the study to determine the subjective curative the surgeons in the study received more training at the rate of SUI or POP; however, the prospectively collected time. It is of note that there are no studies which illustrate objective curative frequency was noted. Furthermore, the perioperative, short-term complications of these geni- different types of complications occur after anterior tourinary surgeries. colporrhaphy compared to mesh operations (i.e. extru- In a single TVM series with the Perigee technique, the sion does not occur after colporrhaphy), and the total average blood loss was found to be 180 ml [33], which complication rate should be interpreted with caution. Fekete et al. BMC Urology (2018) 18:53 Page 10 of 11 Conclusions 6. Hiltunen R, Nieminen K, Takala T, Heiskanen E, Merikari M, Niemi K, Heinonen PK. Low-weight polypropylene mesh for anterior vaginal wall In summary, use of a modified transvaginal mesh re- prolapse: a randomized controlled trial. Obstet Gynecol. 2007;110(2):455–62. sulted in a higher rate of treatment success than the 7. Sergent F, Resch B, Diguet A, Verspyck E, Marpeau L. Vaginal prolapse and traditional mesh operation or non-mesh reconstructive stress urinary incontinence: combined treatment by a single prosthesis. Prog Urol. 2006;16(5):361–7. surgery (colporrhaphy) for repair of anterior vaginal-wall 8. Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Marjoribanks J. prolapse and stress incontinence. By seeking a balance Transvaginalmesh or grafts compared with native tissue repair for vaginal between the highly effective anti-incontinence and POP prolapse. Cochrane Database Syst Rev. 2016;(Issue 2) Art. No.: CD012079. DOI: 10.1002/14651858.CD012079 repair of the prosthesis operations and the less harmful 9. Hannestad YS, Rortveit G, Sandvik H, Hunskaar S. A community-based non-mesh repairs, the mTVM could be a reasonable epidemiological survey of female urinary incontinence: the Norwegian choice with a high SUI and coexisting POP reconstruct- EPINCONT. J Clin Epid. 2000;53(11):1150–7. 10. US Food and Drug Administration. UPDATE on Serious Complications ive effect, thus ensuring lower rates of intra- and postop- Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ erative adverse events. Further randomized studies are Prolapse: FDA Safety Communication. 2011. http://wayback.archive-it.org/ therefore necessary to compare the efficacy of this novel 7993/20170722150848/https://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/ucm262435.htm intervention with that of double-sling procedures. 11. Abbott S, Unger CA, Evans JM, Jallad K, Mishra K, Karram MM, Iglesia CB, Rardin CR, Barber MD. Evaluation and management of complications from Abbreviations: synthetic mesh after pelvic reconstructive surgery: a multicenter study. Am J CD: Clavien–Dindo classification system; DNUS: De novo urge symptoms; Obstet Gynecol. 2014;210(2):163. e1–8 ISD: Intrinsic sphincter deficiency; mTVM: Modified transvaginal mesh 12. Yonguc T, Bozkurt IH, Sen V, Aydogdu O, Yonguc GN, Gunlusoy B. Double-sling operation; PFMT: Pelvic floor muscle training; POP: Pelvic organ prolapse; procedure for the surgical management of stress urinary incontinence with POP–Q II: Pelvic organ prolapse quantification system stage II; SUI: Stress concomitant anterior vaginal wall prolapse. Int Urol Nephrol. 2015;47(10):1611–7. urinary incontinence; TVL: Lotal vaginal length; TVM: Transvaginal mesh 13. van der Ploeg JM, Oude Rengerink K, van der Steen A, van Leeuwen JH, operation; TVT-O: Transobturator tape operation; UTI: Urinary tract infection Stekelenburg J, Bongers MY, Weemhoff M, Mol BW, van der Vaart CH, Roovers JP. Transvaginal prolapse repair with or without the addition of a Availability of data and materials midurethral sling in women with genital prolapse and stress urinary Our datasets are publicly available at the following link: https://doi.org/ incontinence: a randomised trial. BJOG. 2015;122(7):1022–30. 10.6084/m9.figshare.3979404 14. Rane A, Kannan K, Barry C, Balakrishnan S, Lim Y, Corstlaans A. Prospective study of the perigee system for the management of cystocoeles – medium- Authors’ contributions term follow up. Aust NZ J Obstet Gynaecol. 2008;48(4):427–32. Z F.: Study design, Data collection, Manuscript writing. SK Data collection. 15. McCulloch P, Altman DG, Campbell WB. No surgical innovation without L P. Manuscript writing, Z B Data analysis, Study design, G N Study design. evaluation: the IDEAL recommendations. Lancet. 2009;374(9695):1105–12. Z K Study design, Data analysis, Manuscript writing. All authors read and 16. Reid F. Assessment of pelvic organ prolapse: a practical guide to the pelvic approved the final version of the manuscript. organ prolapse quantification. Obstet Gynaecol Reprod Med. 2014;24(6):170–6. 17. Urinary incontinence in women: management 2015 NICE guidelines Competing interests [CG171] https://www.nice.org.uk/guidance/cg171 Urinary Incontinence EBU The authors declare that they have no competing interests. Guideline 2016 https://uroweb.org/guideline/urinary-incontinence 18. Urinary Incontinence EBU Guideline 2016 November. https://uroweb.org/ guideline/urinary-incontinence Publisher’sNote 19. Majoros A, Hamvas A, Keszthelyi A, Romics I. Value of testing the abdominal Springer Nature remains neutral with regard to jurisdictional claims in leak point pressure in the differential diagnosis of urinary stress published maps and institutional affiliations. incontinence. Orv. Hetilap. 2003;144(47):2321–5. [Article in Hungarian] 20. Altman D, Väyrynen T, Engh ME, Axelsen S, Falconer C. Nordic transvaginal Author details mesh group. Anterior colporrhaphy versus transvaginal mesh for pelvic- Department of Urology, University of Szeged, Hungary, Semmelweis u. 1, organ prolapse. N Engl J Med. 2011;364(19):1826–36. Szeged H-6725, Hungary. Department of Obstetrics and Gynaecology, 21. Cervigni M, Natale F, La Penna C, Panei M, Mako A. Transvaginal cystocele University of Szeged, Hungary, Semmelweis u. 1, Szeged H-6725, Hungary. repair with polypropylene mesh using a tension-free technique. Int Department of Obstetrics and Gynaecology, Blekinge Hospital, Karlskrona, Urogynecol J Pelvic Floor Dysfunct. 2008;19(4):489–96. Sweden. 22. Tubach F, Brouwer T, Dahmani S, Mantz J, Desmonts JM. Predictive factors Received: 20 January 2017 Accepted: 11 May 2018 of early postoperative urinary retention in the postanesthesia care unit. Anesth Analg. 2005;101(2):592–6. 23. Lamonerie L, Marret E, Deleuze A, Lembert N, Dupont M, Bonnet F. Prevalence of postoperative bladder distension and urinary retention References detected by ultrasound measurement. Br J Anaesth. 2004;92(4):544–6. 1. Molander U, Milsom I, Ekelund P, Mellström D. An epidemiological study of 24. 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Does anchoring vaginal mesh increase the potential for correcting stress incontinence?

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Abstract

Background: This study aims to explore the feasibility of anchoring a four-arm transvaginal mesh (TVM) to the mid- urethra to correct an anterior compartment POP–Quantification stage II–III (Q II–III) and concomitant genuine SUI. Methods: We analysed clinical data from 248 patients with stage II–III anterior prolapse and concomitant SUI who had undergone surgery at a tertiary referral centre in Hungary between January 2008 and June 2010. One hundred and twenty-four women treated with anterior colporrhaphy and 62 patients implanted with a conventional permanent TVM were selected as historical matched controls. Sixty-two patients received a modified permanent TVM, where the mesh was fixed to the mid-urethra with two stitches for the purpose of potentially correcting SUI. Surgical complications were classified using the Clavien–Dindo (CD) classification system. Results: The anti-SUI efficacy was minimally higher in the mTVM group than in the original TVM group (p = 0.44, 96.8% vs 91.9%, respectively), while prosthesis surgery was more effective than anterior colporrhaphy in improving the anterior compartment POP–Q status (96.8, 90.3% vs 64.5%, respectively). Anchoring the mesh did not increase the extrusion rate (p = 0.11). The de novo urge symptoms were not more prevalent among those who had received additional periurethral stitches (p = 1.00, 11.3% vs 12.9%). The incidence of reoperation observed in the mTVM group was non-significantly lower than that in the TVM group (p = 0.15, 6.5% vs 16.1%); however, the difference did not reach the level of significance. The early postoperative complication profile was more favourable among the mTVM patients (classified as CD I: 8.1%; CD II: 1.6%; and CD IIIb: 1.6%) as compared to the TVM group (p = 0.013). Conclusions: The new, modified mesh surgery represents an effective procedure for prolapse and concomitant SUI with a decreased risk of short- and long-term complications. Keywords: Modified transvaginal mesh, Transobturator tape, Anterior colporrhaphy, Complications, SUI with POP–QII, Clavien–Dindo classification Background view of the low recurrence rate (6.7–24%) [5–8] relative to Coexisting stress urinary incontinence (SUI) and pelvic that after classical anterior colporrhaphy (30–40%) [6, 8, 9]. organprolapse(POP) arehighlyprevalent (63–80%) [1], and A recent Cochrane review confirms the superiority of the cumulative risk of surgery for POP or SUI by the age of repairing prolapse of the mid-anterior vaginal wall with 80 years has been estimated at 11.1% [2, 3]. Despite the permanent mesh over native tissue repair [8]. However, a availability of a wide variety of prolapse surgery, there is no worldwide spread of a range of vaginal mesh operations has consensus on the optimal treatment. Vaginal prosthetic resulted in ahugenumberof complications (e.g.infection, surgery has been proposed foranteriorcompartment POP– extrusion and de novo urge symptoms). As a consequence, Quantification (Q) stage II–III (International Continence the US Food and Drug Administration has published Society/International Urogynecological Association) [4]in warnings with the aim of restricting the utilization of vaginal prosthesis to centres with specially trained surgeons after patients have been thoroughly informed [10]. Furthermore, * Correspondence: fekete.zoltan@med.u-szeged.hu Department of Urology, University of Szeged, Hungary, Semmelweis u. 1, it is assumed that a combination of a synthetic mesh with Szeged H-6725, Hungary the sling operation [11–13] will substantially increase the Department of Obstetrics and Gynaecology, University of Szeged, Hungary, cure rate of concomitant SUI. In contrast, the combined Semmelweis u. 1, Szeged H-6725, Hungary Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Fekete et al. BMC Urology (2018) 18:53 Page 2 of 11 techniques represent an increased complication rate and of Helsinki) for experiments involving humans and was elevated financial burden. approved by the Ethics Committee, Faculty of Medicine, It is well known that the supporting position of the University of Szeged (Protocol No. 194/2010). The prosthesis differs slightly with the transvaginal mesh Institutional Review Board supervised patient monitoring. (TVM) and transobturator tape (TVT-O). The TVT-O Written informed consent was obtained from all partici- sling is located under the mid-urethra, whereas the TVM pants after the advantages and possible complications of elevates the whole anterior and middle compartment [14]. the modified surgery were explained in detail. TVM produces a significantly weaker anti-SUI effect com- All the patients who exhibited coexisting symptoms pared to that of the TVT-O since TVM elevates the (both SUI and POP–QII–III) were recruited prospectively urinary bladder neck [7]. Furthermore, we hypothesise into the study. The symptomatic POP–Qstage II–III an- that the original TVM operation can be followed by terior prolapse is defined as the maximum extent of the residual SUI as the strengthening of the back arms may prolapsed anterior vaginal wall being within 1 cm above result in a backward sliding of the entire mesh, leading to and 6 cm below the hymen [4, 16]. According to the inter- alackofsuspension ofthe urethra. national POP guidelines (the EBU and NICE guidelines) We propose a modification of the four-arm TVM pro- [17, 18], if the condition disrupts the patient’slifeand cedure in an attempt to achieve a better SUI correction, nonsurgical treatment options have not helped, it should without any decrease in prolapse repair efficacy. We be treated surgically. POP repair was considered effective have developed a new method where the mesh is if a significant (> 1 cm) improvement was measured at sutured to the mid-urethra in order to prevent the back- points Aa, Ba and C and in total vaginal length (TVL) ward sliding, and, in this way, the anterior arms mainly during the follow-up in accordance with the POP–Q elevate the middle part of the urethra, potentially leading system (International Continence Society) [4, 16]. to effective anti-incontinence. In other words, the an- Anti-incontinence efficacy was determined if no further chored mesh takes over the function of the pubourethral SUI was diagnosed by urodynamic examination. ligament, which should normally stabilize the urethra, In all cases, urodynamic examinations comprising but is loose in SUI. uroflowmetry, cystometrography and abdominal leak We demonstrate an alternative operative method for point pressure tests were performed before surgery to POP–QII–III repair and anti-incontinence with the objectively determine the coexisting symptomatic SUI TVM fixed to the mid-urethra. The efficacy and short- based on the international guidelines (the EBU and and long-term complication profiles of this new surgical NICE guidelines) [15, 16]. The abdominal leak point technique were compared with those of historical con- pressure test was used as a standardised examination trols involving original TVM and anterior colporrhaphy method for the evaluation of SUI with urine leakage as a operations at our departments. sign. If the intraabdominal pressure recorded at the point of urine leakage was less than 40 cmH O, the Methods origin of the SUI was set as intrinsic sphincter deficiency The prospective longitudinal cohort study comprised 62 (ISD) [19]. In the case of ISD, preoperative pelvic floor women who presented for the correction of SUI in con- muscle training (PFMT) was recommended. If the junction with symptomatic anterior compartment POP–Q patient was unwilling to do PFMT or the training was II–III at the Departments of Urology and Obstetrics and unsuccessful, a modified TVM operation was recom- Gynaecology, University of Szeged, Hungary, between mended. This was also recommended in the case of sus- January 2010 and June 2010. The trial was conducted in pected urethral hypermobility – i.e. if the intraabdominal accordance with the IDEAL consensus. After the idea pressure at the point of urine leakage was higher than 60 (IDEAL stage 1) of concomitant surgery for SUI and POP cmH O. Preoperative irritating voiding symptoms were was developed, ten operations were performed with a high not an exclusion criterion before the study. cure rate of both symptoms in all cases after four weeks All the data were collected prospectively. Further in- (IDEAL stage 2). Based on these data, TVM or anterior clusion criteria in the study were negative urinary cultur- colporrhaphy and delayed TVT-O for SUI and coexisting ing and ineffective non-surgical treatment or patient’s POP repair have been replaced by the new surgery in our unwillingness to receive conservative treatment. The ex- departments (IDEAL stage 3) [15]. The patients were clusion criteria were as follows: occult SUI, a history of monitored during monthly outpatient appointments in mesh use or anti-incontinence pelvic procedures, anti- the first six months; thereafter, check-ups occurred every depressant therapy, pregnancy, whether the patient was half year. The Institutional Review Board regularly in the puerperal period and up to six months reviewed the clinical data on the patients. post-partum, and cancer of the pelvic organs. Our work was carried out in accordance with the Code There are no clear international recommendations on of Ethics of the World Medical Association (Declaration surgical anterior compartment POP–Q II repair, but an Fekete et al. BMC Urology (2018) 18:53 Page 3 of 11 increasing body of evidence suggests that TVM is a bet- ter treatment option for anterior wall prolapse ≥ stage II than traditional anterior colporrhaphy [7, 20, 21]. We have modified the transobturator TVM operation re- ported by Sergent et al. [7] by inserting two additional stabilizing sutures which fix the anterior edge of the mesh to the paraurethral tissues at the level of the mid-urethra. All operations were carried out with 100% polypropylene monofilament permanent meshes pro- duced by Aspide® SURGIMESH® PROLAPSE (Aspide Médical, La Talaudière, France). The implanted vaginal prosthesis has pores which are 1.6 × 1.7 mm in size and is approved for anterior vaginal repair. Surgery was performed under general anaesthesia with the patient in the lithotomy position with an indwelling urinary catheter. The anterior vaginal wall was incised longitudinally throughout its thickness from the cervix to 1 cm below the urethral meatus, under the mid-ure- Fig. 1 Anchoring stitches stabilize the mesh position under the mid-urethra thra. The thickness of the dissection, the location of the vaginal incision, the placement of the mesh and the closure of the incision varied only minimally, and the The historical controls comprised 62 patients with length of the incision varied only between 6 and 7 cm. genuine SUI verified by urodynamic examination with Before insertion, all sterile meshes were soaked in iodic grades of POP II–III who had originally undergone a fluid (Betadine®). The Surgimesh® device was introduced TVM operation (control group I). A further 124 patients beneath the dissection. Its four arms were then passed with anterior compartment symptomatic POP–Q II and through the obturator membrane. The posterior part of any SUI corrected by anterior colporrhaphy operations the mesh was anchored to the anterior side of the (control group II) were also operated on by the same cervix using two Prolene® 2–0sutures (Ethicon, two senior surgeons at the departments. The data on the Issy-les-Moulineaux, France). historical controls were retrieved retrospectively from The mesh was then spread by securing its anterior the medical database between January 2008 and December parts beneath the mid-urethra using two Vicryl 2–0® 2009. Eligibility for the operation and consistent collection absorbable sutures (Ethicon, Issy-les-Moulineaux, of outcome measurements (operative characteristics and France) and promoting the proper elevation and closure post-operative findings) were tied to a follow-up schedule of the urethra (Fig. 1). The mesh was then adjusted in a which was routinely established in the historical groups. tension-free manner beneath the distal part of the This schedule was followed for the mTVM group as well. urethra and bladder, and the anterior vaginal wall was The follow-up period in the control groups was also three closed using Monocryl® 3–0 absorbable sutures (Ethicon, years. Baseline and follow-up evaluations after six weeks to Issy-les-Moulineaux, France) with a slight colpectomy. three years were performed by an experienced urogynaecol- All the operations were performed by the same two ogist. All the patients were given an appointment for the experienced senior surgeons, and there were no dif- subsequent medical consultation according to a follow-up ferences in the operative processes. arrangement (Table 1). When a patient missed an appoint- Prophylactic preoperative antibiotics (cefazolin 1 g, ment, a urogynaecologist reminded her by telephone, and, amoxicillin and clavulanic acid 1.2 g or gentamycin hence, there was no registered loss due to lack of follow-up 160 mg) were administered intravenously. A urinary in our samples. For each case, we matched controls in each catheter was removed on the morning of the postoperative control arm (groups I and II) who were as similar as day. A vaginal gauze pack (gauze soaked in Betadine possible in age, systemic diseases, and previous parity and iodine) was placed for 12 h. The post-voided residual urine vaginal operations. was measured by ultrasonography before each patient was The factors studied were the demographic and patient discharged. All the patients participated in topical intravagi- data, the intraoperative findings and postoperative nal oestrogen cream treatment for at least twelve months factors. Furthermore, the incidence of systemic chronic following the operation (Ovestin® 1 mg/gram daily), but diseases that might have a detrimental effect on the none of the patients took part in preoperative oral hormone healing process (i.e. in diabetes mellitus and auto- replacement therapy. The follow-up period after the modi- immune diseases) was also recorded, and displacement fied TVM operation was 36 months. of the implant due to chronic coughing in airway Fekete et al. BMC Urology (2018) 18:53 Page 4 of 11 Table 1 Schedule of assessments/data collection for both Assessment Recruitment before Intervention Follow-up intervention phase (Surgery) 6 weeks 6 months 1 years 2 years 3 years Written informed consent x Gynaecological examination: incontinence symptoms x x X x x x X Gynaecological examination: prolapse x x X x x x X Urodynamic examination x x X Adverse events x X x x x X Urine culture x x x x X available in the modified transvaginal mesh operated women diseases was also considered. As concerns the long-term the odds for continuous variables. Multiple logistic regres- postoperative complications of the sling and mesh pro- sion was used to adjust the comparisons of the groups in cedures, we determined the rejection rate, the presence terms of age, previous parity, postmenopausal stage, previ- of de novo urge symptoms (DNUS) or urinary tract ous vaginal operations, chronic systemic diseases, POP–Q infection (UTI), and the need for reoperation. The stage and urge symptoms due to inequalities between diagnosis of DNUS was set if detrusor pressure changes cases and controls. A two-tailed p-value of < 0.05 was were detected in cystometrographic pressures after the judged as significant. The power of the statistical tests surgeries. The postoperative complications that led to ranged between 74 and 99% in the study. reoperation were infection, recurrent descent or incon- tinence, implant extrusion, chronic pelvic pain and total Results retention. Prosthetic extrusion was diagnosed by the Table 2 presents the baseline characteristics of the par- presence of exposed graft material in the vagina. ticipants in the study groups. Maternal age and BMI Post-void residual urine is a measurement of the urine were significantly higher among the mesh-operated that remains in the bladder less than 20 min following patients (p < 0.001 and p = 0.004, respectively). The vast voiding which identifies urinary retention. Bladder majority was postmenopausal in all groups; however, the volumes that suggest urinary retention are commonly highest rate was noticed disproportionally among those defined as greater than 500 to 600 ml [22, 23]. DNUS who had undergone mTVM (97%). was classified as a sudden involuntary contraction of the There was a trend of patients with modified mesh muscular wall of the bladder causing urinary urgency, an having vaginal deliveries and vaginal operations at the immediate unstoppable urge to urinate with a postopera- highest rate; however, the differences between the tive onset. groups were not significant. No significant differences Operative and perioperative complications (six weeks were observed between groups in any type of chronic after the procedures) described after mTVM and systemic diseases. historical operations were collated, overall frequency Table 3 lists the operative characteristics and compli- within all cases were calculated, and severity was graded cations, while Table 4 provides the odds and adjusted using the Clavien–Dindo classification comprising all odds of the differences in baseline and surgical charac- the follow-up periods. More specifically, additional teristics in the three study groups. The operation took a medication due to deviation from the normal postopera- similar amount of time in the mTVM group as com- tive course (pain, fever, wound infection and minimal pared with the anterior colporrhaphy (Adjusted odds bleeding) was categorized as Grade I, UTIs requiring rate (AOR): 1.03) or TVM (AOR: 0.97) control group. antibiotic treatment and SUI/POP without any postoper- The estimated blood loss during the operation was ative correction, DNUS or blood transfusion were significantly lower in the mTVM group than in control grouped as Grade II, and reoperation performed in group I (AOR: 0.96, p < 0.001) and control group II general anaesthesia was graded as IIIb [22]. (AOR: 0.96, p < 0.001). The occurrence of bladder injury and the need for immediate postoperative blood transfu- Statistical analysis sion were negligible in all the study groups. The SPSS 17.0 program package was used to analyse the The reoperation rate was significantly the lowest in the data. The non-parametric design of the continuous mTVM group at 6.5% as compared to that in the anterior variables was verified with the Shapiro–Wilk test. The colporrhaphy group (32.1%) (AOR: 0.07, p < 0.001) and categorical and continuous variables were compared that of 16.1% in the TVM group (AOR: 0.22, p =0.15). with the χ test and Kruskal–Wallis test, respectively. The rate of implant removal was lower among those Univariate logistic regression was employed to determine mesh-operated patients who had undergone the modified Fekete et al. BMC Urology (2018) 18:53 Page 5 of 11 Table 2 Baseline characteristics of patients who presented for operation for POP–QII–III and genuine SUI between January 2006 and December 2012 Modified TVM group Control group I Control group II (historical controls: p value (N = 62) (historical controls: TVM) (N = 62) anterior colporrhaphy) (N = 124) Age (y) (mean ± S.D.) 62.9 ± 7.7 59.7 ± 10.1 55.9 ± 11.1 < 0.001 BMI (kg/m ) (mean ± S.D.) 29.4 ± 2.9 28.4 ± 3.0 27.8 ± 3.8 0.004 Previous vaginal deliveries (mean ± S.D.) 2.3 ± 1.2 2.1 ± 0.6 2.1 ± 0.8 0.71 Postmenopausal women, n (%) 60 (96.8) 47(75.8) 92 (74.2) 0.001 Previous vaginal operations, n (%) 24 (38.7) 14 (22.6) 36 (29.0) 0.14 Chronic systemic diseases, n (%) 17 (27.4) 16 (25.8) 18 (14.5) 0.06 Diabetes mellitus, n (%) 10 (16.1) 10 (16.1) 9 (7.3) 0.09 Autoimmune diseases, n (%) 4 (6.5) 3 (4.8) 5 (4.0) 0.77 Airway diseases, n (%) 5 (8.1) 3 (4.8) 6 (4.8) 0.64 All recruited patients presented for anterior compartment POP–QII–III (pelvic organ prolapse) and genuine SUI (stress urinary incontinence). The modified transvaginal mesh (mTVM) group comprised patients who received a four–arm mesh that was fixed to the mid-urethra. Control groups I and II include historical controls who had participated in TVM and anterior colporrhaphy without any Kelly–Stoeckel suture, respectively Chronic systemic diseases include diabetes mellitus, airway diseases and autoimmune diseases technique than those with the original TVM (AOR: 0.13, operation. All implants were removed because of the 1.6% vs 9.7%, respectively); however, the difference did not extrusion of the vaginal wall. No rectal or bladder reach a significant level. One reoperation occurred in the fistula, pelvic abscess or haematoma was observed in mTVM group due to apical compartment POP (1.6%), an- any of the groups. other (1.6%) was performed due to anterior compartment Modifying the TVM technique led to a signicantly descent after the removal of the extruded mesh, a third higher elevation of point Aa compared to the traditional (1.6%) for SUI and a fourth (1.6%) for postoperative pain. TVM (AOR: 4.83) with a significantly reduced shorten- In addition, reoperation due to postoperative POP had a ing of the vagina (AOR: 0.41). The mTVM significantly frequency of 8.1%, and one patient (1.6%) required improved the prolapse status (POP–Q of Aa, AOR: reoperation due to SUI in the original TVM group. The 142.9; Ba, AOR: 5.95; and C, AOR: 25.0) compared to colporrhaphy patients needed more reoperations (32.1%), that of anterior colporrhaphy, whereas the total vaginal and the difference was robust (AOR: 0.007). All the cases length was significantly shortened (p < 0.001) (Table 5). involving POP recurrence (3.2 and 9.7%, AOR: 2.94) follow- Table 6 demonstrates the postoperative complications ing the two mesh operations were found in the untreated within six weeks according to the Clavien–Dindo classi- compartment, posteriorly behind the mesh-supported area. fication. A total complication rate of 11.3% in the The recurrence of anterior compartment POP (35.5%, mTVM group, 35.5% in the TVM group and 22.6% in p < 0.001) and SUI (38.7%, p < 0.001) or reoperation the colporrhaphy group was noted with significant differ- duetorecurrenceof SUI (8.9%, AOR: 0.11, p = 0.06) ences (p = 0.013). Subanalyses were performed indicating and POP (25.0%, AOR: 0.05, p < 0.001) during the that the complications occurred with a non-significantly follow-up period was typical of the anterior colporrha- lower prevalence among the mTVM participants phy patients. As expected, slightly more cases of SUI compared to the anterior colporrhaphy group (AOR: 0.56, were cured in the mTVM group than in the TVM p = 0.3), whereas the difference was significantly lower in group (96.8% vs 91.9%), although the differences were the mTVM group than among the TVM participants not significant (AOR: 2.98). Prolapse repair was (AOR: 0.29, p = 0.02) (data are not shown). CD I compli- achieved in a significantly higher proportion of the cations predominantly occurred in the two groups of patients who underwent mTVM compared to their women operated on with prostheses, whereas the anterior colporrhaphy counterparts (96.8% vs 64.5%, historical anterior colporrhaphy operations were followed AOR: 14.16 p < 0.001). Modification of the TVM mostly by CD II. displayed a moderate effect on POP recurrence compared to the original operation (9.7%) (AOR: 2.94, Discussion p = 0.27). Urinary tract infection was not more preva- The most striking result of this study is that the transva- lent after the prosthesis operations than after anterior ginal implantation of the four-arm mesh sutured to the colporrhaphy. The rate of extrusion was nearly four mid-urethra, a new modification of the TVM procedure times higher in the TVM group than in the mTVM [7], is highly effective in the repair of an anterior group (AOR: 0.13, p = 0.11), with extrusion appearing prolapse (POP–QII–III) and in genuine stress urinary earlier in the group that underwent a non-modified incontinence (SUI). Success rates of 96.8 and 96.8% were Fekete et al. BMC Urology (2018) 18:53 Page 6 of 11 Table 3 Operative characteristics and postoperative complications of patients who presented for operation for POP–QII–III and genuine SUI between January 2006 and December 2012 Modified TVM Control group I (historical Control group II (historical controls: p value group (N = 62) controls: TVM) (N = 62) anterior colporrhaphy) (N = 124) POP grading grade II 50 (80.6) 59 (95.2) 124 (100) < 0.001 grade III 12 (19.4) 3 (4.8) 0 (0) Urge symptoms 8 (12.9) 2 (3.2) 7 (5.6) 0.08 Duration of operation (min) (mean ± S.D.) 37.8 ± 7.4 38.8 ± 6.0 34.9 ± 7.9 < 0.001 Estimated blood loss (ml) (mean ± S.D.) 48.7 ± 21.8 83.8 ± 41.2 74.0 ± 33.4 < 0.001 Intraoperative bladder injury, n (%) 1 (1.6) 0 (0) 0 (0) 0.22 Blood transfusion, n (%) 0 (0) 0 (0) 1 (0.8) 0.61 Reoperation, n (%) 4 (6.5) 10 (16.1) 40 (32.3) < 0.001 POP–Q, n (%) 2 (3.2) 5 (8.1) 31 (25.0) < 0.001 SUI, n (%) 1 (1.6) 1 (1.6) 11 (8.9) 0.04 Vaginal wall extrusion, n (%) 1 (1.6) 6 (9.7) 0 (0) 0.11 Postoperative bleeding, n (%) 0 (0) 3 (4.8) 1 (0.8) 0.06 Postoperative pain, n (%) 1 (1.6) 0 (0) 0 (0) 0.22 Total retention, n (%) 0 (0) 1 (1.6) 1 (0.8) 0.61 Successful treatment of POP–Q, n (%) 60 (96.8) 56 (90.3) 80 (64.5) < 0.001 Successful treatment of SUI, n (%) 60 (96.8) 47 (75.8) 76 (61.3) < 0.001 Urinary tract infection, n (%) 11 (17.7) 14 (22.6) 23 (18.5) 0.75 De novo urge incontinence, n (%) 7 (11.3) 8 (12.9) 0 (0) < 0.001 Average time to observed extrusion (months) (mean ± S.D.) 1 ± 0 13.7 ± 8.3 n.m. 0.13 All recruited patients presented for anterior compartment POP–QII–III (pelvic organ prolapse) and genuine SUI (stress urinary incontinence). The modified transvaginal mesh (mTVM) group comprised patients who received a four–arm mesh that was fixed to the mid-urethra. Control groups I and II include historical controls who participated in TVM and anterior colporrhaphy without any Kelly–Stoeckel suture, respectively. n.m. , not measurable demonstrated for genuine SUI and prolapse, respectively. mid-urethra, where the pubourethral ligament originally This surgical procedure for prosthetic placement pro- held it, helps to elevate the middle region, this being con- vided a minimally better SUI reconstructive effect than sidered the treatment of SUI that is at least as effective as that of the TVM procedure in our historical control the TVT-O technique (91.2% in our non-published data group (91.9%) or that reported in the literature (69–90.3%) and 92% in the literature) [30]. In other words, anchoring [24–26]. With regard to the POP repair, mTVM (96.8%) the anterior part of the mesh to the mid-urethra imitates proved significantly more effective than historical anterior the mechanism of action of the mid-urethral sling as an colporrhaphy (64.5%), but only minimally higher than that additional procedure for SUI correction. The original of the non-modified, transobturator mesh technique in our TVM has a limited anti-SUI mechanism. database (90.3%) and that demonstrated in the literature Furthermore, our results suggest a better anatomical (with a rate of 82.3–100%) [5, 20, 21, 26–29]. Fixing the success rate after the mesh is fixed to the mid-urethra, anterior arm of the mesh to the periurethral tissue elevates which may be explained by the lack of shrinkage and less point Aa significantly more effectively than the original folding of the mesh. By contrast, our results might allow TVM with less vaginal shortening. for the speculation that prosthesis stabilization with TVM supports the whole of the anterior and middle sutures to prevent any backward movement could lead compartments, but does not elevate the middle of the to prolapse recurrence in the untreated middle com- urethra and, hence, theoretically allows for urethral partment, i.e. in the area not supported by the mesh. dorsal rotation, which may lead to residual SUI, We attribute our lower anatomical recurrence of especially if the mesh is able to migrate a bit more pos- mTVM to a wider suspension area of the insertion of a teriorly toward the cervix. It is also possible that mesh smooth, non-folded mesh. To check on this, we have movements could be responsible for DNUS with the launched a further study at our department, in which traditional TVM method. Using stabilizing sutures to fix the posterior arms of the TVM are anchored towards the mesh to the paraurethral tissues at the level of the the pericervical ring to provide apical support. Fekete et al. BMC Urology (2018) 18:53 Page 7 of 11 Table 4 Crude odds ratios (OR) and adjusted OR (AOR) for confounders in various comparisons of patients who presented for operation for POP–QII–III and genuine SUI between January 2006 and December 2012 Modified TVM group vs Control group I Modified TVM group vs Control group II (historical controls: TVM) (historical controls: anterior colporrhaphy) a a p value Unadjusted OR Adjusted OR p value Unadjusted OR Adjusted OR (95% CI) (95% CI) (95% CI) (95% CI) Age 0.05 1.04 (1.00–1.08) 1.02 (0.97–1.08) < 0.001 1.07 (1.04–1.11) 1.05 (1.01–1.10) BMI 0.05 1.13 (1.00–1.29) 1.12 (0.96–1.30) 0.001 1.14 (1.04–1.25) 1.13 (1.01–1.26) Previous vaginal deliveries 0.26 1.28 (0.83–1.98) 1.57 (0.90–2.76) 0.45 1.15 (0.84–1.58) 1.18 (0.79–1.76) Postmenopausal women 0.001 9.6 (2.09–4.35) 11.58 (1.78–75.1) < 0.001 10.44 (2.41–45.2) 8.09 (0.98–67.05) Previous vaginal operations 0.08 2.16 (0.99–4.74) 2.16 (0.86–5.44) 0.19 1.54 (0.81–2.93) 1.29 (0.59–2.80) Chronic systemic diseases 1.00 1.09 (0.49–1.41) 0.95 (0.37–2.41) 0.045 2.23 (1.05–4.71) 1.84 (0.77–4.41) Diabetes mellitus 1.00 1.00 (0.38–2.60) 0.77 (0.16–4.46) 0.07 2.46 (0.94–6.11) 0.86 (0.19–3.88) Autoimmune diseases 1.00 1.36 (0.29–6.33) 3.23 (0.41–25.67) 0.48 1.64 (0.43–0.34) 1.99 (0.34–11.59) Airway disorders 0.72 1.72 (0.40–2.58) 0.90 (0.15–5.54) 0.51 1.73 (0.51–5.89) 0.4 (0.08–2.14) POP–Q III vs II 0.02 4.71 (1.26–17.5) 6.32 (1.07–37.52) < 0.001 1.24 (1.10–4.40) 1.36 (1.08–4.10) Urge symptoms 0.09 4.44 (0.90–21.74) 4.85 (0.91–25.94) 0.10 2.48 (0.85–7.18) 3.02 (0.84–10.90) Duration of operation 0.41 0.98 (0.93–1.03) 0.97 (0.91–1.03) 0.22 1.05 (1.01–1.09) 1.03 (0.98–1.09) Estimated average blood loss < 0.001 0.96 (0.95–0.98) 0.96 (0.94–0.98) < 0.001 0.96 (0.94–0.97) 0.96 (0.94–0.98) b b b Intraoperative bladder injury 1.00 1.02 (0.98–1.05) n.m. 0.33 1.02 (0.99–1.05) n.m. b b b b Blood transfusion n.m n.m n.m. 1.00 0.99 (0.98–1.01) n.m. Reoperation 0.15 0.36 (0.11–1.21) 0.22 (0.04–1.10) < 0.001 0.15 (005–0.43) 0.07 (0.02–0.32) POP 0.44 0.38 (0.07–2.04) 0.26 (0.04–1.96) < 0.001 0.10 (0.02–0.43) 0.05 (0.006–0.41) SUI 1.00 1.00 (0.06–16.39) 0.19 (0.01–5.7) 0.06 0.17 (0.02–1.34) 0.11 (0.06–0.89) b b Vaginal wall extrusion 0.11 0.15 (0.02–1.31) 0.13 (0.009–1.71) n.m n.m. n.m. Bleeding 0.24 0.95 (0.90–1.01) n.m. 1.00 0.99 (0.98–1.01) 0.89 (0.68–1.12) b b Postoperative pain 1.00 1.02 (0.98–1.05) n.m. 0.33 1.02 (0.99–1.05) n.m. b b Total retention 1.00 0.98 (0.95–1.02) n.m. 1.00 0.99 (0.98–1.01) n.m. Successful treatment of POP–Q 0.27 3.22 (0.62–16.67) 2.94 (0.47–18.6) < 0001 16.5 (3.85–70.77) 14.16 (3.09–65.00) Successful treatment of SUI 0.004 9.58 (2.09–43.9) 72.2 (8.56–606.65) < 0.001 18.95 (4.43–81.13) 96.2 (7.40–1250.0) Urinary tract infection 0.66 0.74 (0.31–1.79) 0.70 (0.26–1.87) 1.00 1.95 (0.43–2.19) 0.92 (0.34–2.45) De novo urge symptoms 1.00 0.86 (0.29–2.53) 0.89 (0.25–3.22) < 0.001 1.13 (1.03–1.23) 1.10 (1.06–1.19) b b b b b Average time to extrusion observed 0.99 n.m. n.m. n.m. n.m. n.m. All recruited patients presented for anterior compartment POP–QII–III (pelvic organ prolapse) and genuine SUI (stress urinary incontinence). The modified transvaginal mesh (mTVM) group comprised patients who received a four–arm mesh that was fixed to the mid-urethra. Control groups I and II include historical controls who participated in TVM and anterior colporrhaphy without any Kelly–Stoeckel suture, respectively OR, Odds ratio; 95% CI, 95% confidence interval, Adjusted OR , All variables were adjusted for age, previous parity, postmenopausal stage, previous vaginal operations and chronic systemic diseases, POP–Q stage and urge symptoms. n.m. , not measurable TVM corrects SUI subjectively in only 83.3% of cases mid-urethral sling in one session has been scarcely studied [7]. Furthermore, subvesical mesh towards the obturator [12, 32]. When TVM was combined with a TVT-O oper- spaces in a total of 74 patients with a stage ≥2 anterior ation [12, 32], the success rate for SUI was 87.8–93.2% prolapse was associated with a symptomatic SUI repair and that for anterior wall repositioning was 94.4–96%, i.e. in 72% of the cases, and cystocele was corrected in 97% a similar anti-incontinence and anatomical reconstruction [27]. The current trend is to resolve the concomitant rate than those in our study, though that follow-up was SUI and POP in a single hospitalization session so as to for up to 60 months. More studies are needed to evaluate reduce medical costs and improve the patient’s satisfac- whether the additional insertion of a TVT-O sling into a tion, but the optimum use of anti-incontinence proce- mesh provides any additional improvement in the SUI dures during pelvic reconstructive surgery remains a and POP cure rate as compared with a single TVM or matter of debate [31]. A combination of mesh with a modified TVM. Fekete et al. BMC Urology (2018) 18:53 Page 8 of 11 Table 5 Patients’ preoperative and postoperative POP-Q status Control group I (historical controls: TVM) p value Unadjasted Adjusted Modified TVM group p value Unadjasted Adjusted OR Control group II (historical controls: (N = 62) OR (95% CI) OR (95% CI) (N = 62) OR (95% CI) (95% CI) anterior colporrhaphy) (N = 124) Pre-operative Post-operative Mean difference Pre-operative Post-operative Mean difference Pre-operative Post-operative Mean difference Aa −0.97 ± 0.6 −1.37 ± 0.55 −0.40 ± 0.61 < 0.001 4.55 4.83 − 0.55 ± 0.69 − 1.68 ± 0.74 − 1.13 ± 0.80 < 0.001 43.5 142.9 −0.97 ± 0.36 − 0.76 ± 0.69 0.21 ± 0.60 (2.38–9.09) (2.26–10.31)0.6 (1.61–125) (28.57–500.0) Ba −0.42 ± 0.64 − 1.74 ± 1.0 −2.16 ± 1.04 0.50 1.12 1.17(0.71–1.52) −0.53 ± 1.08 −1.76 ± 0.94 −2.3 ± 1.08 < 0.001 6.49 5.95 − 0.49 ± 0.75 − 0.94 ± 1.48 − (0.8–1.56) (3.65–11.63) (3.27–10.87) 0.45 ± 1.17 C −6.55 ± 1.16 −6.82 ± 0.85 −0.27 ± 0.6 0.70 0.90 1.20(0.66–2.16) − 6.53 ± 0.82 − 6.76 ± 0.67 − 0.23 ± 0.58 < 0.001 23.81 25.0 − 6.74 ± 0.61 − 6.45 ± 0.83 0.29 ± 0.62 (0.54–1.52) (3.34–166.67) (3.70–166.7) b b TVL 8.25 ± 0.67 7.9 ± 0.62 −0.35 ± 0.48 0.018 0.37 0.41(0.16–0.99) 7.82 ± 0.42 7.66 ± 0.60 −0.16 ± 0.41 < 0.001 n.m. n.m. 7.91 ± 0.29 7.91 ± 0.29 0.0 ± 0.0 (0.16–0.86) All recruited patients presented for anterior compartment POP–QII–III (pelvic organ prolapse) and genuine SUI (stress urinary incontinence). The modified transvaginal mesh (mTVM) group comprised patients who received a four–arm mesh that was fixed to the mid-urethra. Control groups I and II include historical controls who participated in TVM and anterior colporrhaphy without any Kelly–Stoeckel suture, respectively OR, Odds ratio; 95% CI, 95% confidence interval, a b Adjusted OR , All variables were adjusted for age, previous parity, postmenopausal stage, previous vaginal operations and chronic systemic diseases, POP–Q stage and urge symptoms. n.m. , not measurable Fekete et al. BMC Urology (2018) 18:53 Page 9 of 11 Table 6 Clavien–Dindo classification for postoperative surgical complications among patients who presented for operation for POP–QII–III and genuine SUI between January 2006 and December 2012 Clavien–Dindo Complications Modified TVM group Control group I Control group II p value grade (N = 62) (historical controls: TVM) (historical controls: anterior colporrhaphy) (N = 62) (N = 124) I Non–pharmacologically 5 (8.1) 12 (19.4) 11 (8.9) 0.013 treated postoperative bleeding, fever, wound infection II Urinary tract infection, 1 (1.6) 7 (11.3) 16 (12.9) post–void residual volume, blood transfusion, treatment for de novo urge symptoms IIIb Reoperation for 1 (1.6) 3 (4.8) 1 (0.8) vaginal wall extrusion Total complications 7 (11.3) 22 (35.5%) 28 (22.6) 0.015 a b CD, Clavien–Dindo. No grade IIIa, IVa, IVb or V complication occurred. Data are expressed as n (%) Surprisingly, the double-sling extrusion rate was ex- was much higher than in our mTVM data series tremely low (0–10%) [12, 32]. The corresponding figures (48.7 ml), and the mean procedure duration was also were 1.6% in our mTVM group and 9.7% among our shorter in the mTVM group (37.8 min vs. 60.9 min) TVM participants, which is in agreement with the mean [36]. value of 11.6% (ranging from 3.9 to 16%) reported in the One of the most frequent long-term complications we literature [4, 20, 24, 27, 33, 34]. The extrusion rate observed with synthetic mesh materials in our series was generally correlates well with the prosthesis breadth; DNUS (11.3% and 12.9), which is an important indicator however, we observed a remarkably higher extrusion rate of the level of patient satisfaction. Post-operative urody- for mesh compared to that for modified mesh. One can namic examinations showed detrusor muscle action in speculate that the lack of stabilizing sutures led to a all the cases suffering from DNUS. The average detrusor “folding/wrinkling” of the edge of the mesh, resulting in muscle pressure was 7.75 cmH O postoperatively, a lifting up and compressing of the mucosa and whereas no sign of detrusor or intravesical pressure ele- deranged periprosthetic vasculature. The reported inci- vation was detected preoperatively. We believe that one dence of prosthesis exposure for double-sling operations possible reason for this is the fact that the mesh cannot is not clear-cut. A wider and double prosthesis involves slide backwards and cannot press the urethra to the a greater chance of bacterial colonization, and the bladder neck after the TVM is modified. The average enhanced preparation may additionally impair blood reported prevalence of de novo dyspareunia following supply to the vaginal wall. vaginal placement of a polypropylene mesh is 14% [37], Anterior colporrhaphy is inferior to mesh procedures i.e. significantly higher than in our study (1.6%) (the data with regard to the effectiveness of POP repair and are not presented in a table). Mesh+sling operations anti-incontinence both in our database and as reported by impair the pelvic blood circulation and induce de novo others (37–85 and 54%, respectively) [20, 33, 35, 36]. The urge symptoms and pelvic pain; however, the reported mTVM greatly improved the POP–Q status in all exam- extrusion rate was 10% [32]. ined compartments in the vagina compared to that of col- Our study had some limitations. The baseline charac- porrhaphy. However, the perioperative complication rate teristics of the patients were not equally distributed in is diminished after non-mesh surgery (22.6%) compared the groups, and, hence, statistical adjustments were used to that after implant surgery (35.5%). This is supported by in multivariate analyses. A further limitation of the study the literature data [20, 28, 35]; however, our modified is its non-randomized manner. The surgeons became mesh procedure produced the lowest complication rate in better trained in the operative techniques, a fact which our dataset (11.3%). The robustly lower complication rate may somehow bias the results. Moreover, it was not an after the mTVM can be partly explained by the fact that aim of the study to determine the subjective curative the surgeons in the study received more training at the rate of SUI or POP; however, the prospectively collected time. It is of note that there are no studies which illustrate objective curative frequency was noted. Furthermore, the perioperative, short-term complications of these geni- different types of complications occur after anterior tourinary surgeries. colporrhaphy compared to mesh operations (i.e. extru- In a single TVM series with the Perigee technique, the sion does not occur after colporrhaphy), and the total average blood loss was found to be 180 ml [33], which complication rate should be interpreted with caution. Fekete et al. BMC Urology (2018) 18:53 Page 10 of 11 Conclusions 6. Hiltunen R, Nieminen K, Takala T, Heiskanen E, Merikari M, Niemi K, Heinonen PK. Low-weight polypropylene mesh for anterior vaginal wall In summary, use of a modified transvaginal mesh re- prolapse: a randomized controlled trial. Obstet Gynecol. 2007;110(2):455–62. sulted in a higher rate of treatment success than the 7. Sergent F, Resch B, Diguet A, Verspyck E, Marpeau L. Vaginal prolapse and traditional mesh operation or non-mesh reconstructive stress urinary incontinence: combined treatment by a single prosthesis. Prog Urol. 2006;16(5):361–7. surgery (colporrhaphy) for repair of anterior vaginal-wall 8. Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Marjoribanks J. prolapse and stress incontinence. By seeking a balance Transvaginalmesh or grafts compared with native tissue repair for vaginal between the highly effective anti-incontinence and POP prolapse. Cochrane Database Syst Rev. 2016;(Issue 2) Art. No.: CD012079. DOI: 10.1002/14651858.CD012079 repair of the prosthesis operations and the less harmful 9. Hannestad YS, Rortveit G, Sandvik H, Hunskaar S. A community-based non-mesh repairs, the mTVM could be a reasonable epidemiological survey of female urinary incontinence: the Norwegian choice with a high SUI and coexisting POP reconstruct- EPINCONT. J Clin Epid. 2000;53(11):1150–7. 10. US Food and Drug Administration. UPDATE on Serious Complications ive effect, thus ensuring lower rates of intra- and postop- Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ erative adverse events. Further randomized studies are Prolapse: FDA Safety Communication. 2011. http://wayback.archive-it.org/ therefore necessary to compare the efficacy of this novel 7993/20170722150848/https://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/ucm262435.htm intervention with that of double-sling procedures. 11. Abbott S, Unger CA, Evans JM, Jallad K, Mishra K, Karram MM, Iglesia CB, Rardin CR, Barber MD. Evaluation and management of complications from Abbreviations: synthetic mesh after pelvic reconstructive surgery: a multicenter study. Am J CD: Clavien–Dindo classification system; DNUS: De novo urge symptoms; Obstet Gynecol. 2014;210(2):163. e1–8 ISD: Intrinsic sphincter deficiency; mTVM: Modified transvaginal mesh 12. Yonguc T, Bozkurt IH, Sen V, Aydogdu O, Yonguc GN, Gunlusoy B. Double-sling operation; PFMT: Pelvic floor muscle training; POP: Pelvic organ prolapse; procedure for the surgical management of stress urinary incontinence with POP–Q II: Pelvic organ prolapse quantification system stage II; SUI: Stress concomitant anterior vaginal wall prolapse. Int Urol Nephrol. 2015;47(10):1611–7. urinary incontinence; TVL: Lotal vaginal length; TVM: Transvaginal mesh 13. van der Ploeg JM, Oude Rengerink K, van der Steen A, van Leeuwen JH, operation; TVT-O: Transobturator tape operation; UTI: Urinary tract infection Stekelenburg J, Bongers MY, Weemhoff M, Mol BW, van der Vaart CH, Roovers JP. Transvaginal prolapse repair with or without the addition of a Availability of data and materials midurethral sling in women with genital prolapse and stress urinary Our datasets are publicly available at the following link: https://doi.org/ incontinence: a randomised trial. BJOG. 2015;122(7):1022–30. 10.6084/m9.figshare.3979404 14. Rane A, Kannan K, Barry C, Balakrishnan S, Lim Y, Corstlaans A. Prospective study of the perigee system for the management of cystocoeles – medium- Authors’ contributions term follow up. Aust NZ J Obstet Gynaecol. 2008;48(4):427–32. Z F.: Study design, Data collection, Manuscript writing. SK Data collection. 15. McCulloch P, Altman DG, Campbell WB. No surgical innovation without L P. Manuscript writing, Z B Data analysis, Study design, G N Study design. evaluation: the IDEAL recommendations. Lancet. 2009;374(9695):1105–12. Z K Study design, Data analysis, Manuscript writing. All authors read and 16. Reid F. Assessment of pelvic organ prolapse: a practical guide to the pelvic approved the final version of the manuscript. organ prolapse quantification. Obstet Gynaecol Reprod Med. 2014;24(6):170–6. 17. 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BMC UrologySpringer Journals

Published: May 31, 2018

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