Received: 23 September 2020 | Revised: 2 November 2020 | Accepted: 15 November 2020 DOI: 10.1002/nau.24586 ORIGINAL CLINICAL ARTICLE Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1‐Year outcomes from a multicentre randomized trial Jordi Sabadell MD1,2 | Anna Pereda‐Núñez MD3 | Fernando Ojeda‐de‐los‐Santos MD4 | Manuel Urbaneja MD5 | Carmen González‐García MD6 | Narcís Camps‐Lloveras MD7 | Àngela Pérez‐Plantado MD8 | Judit Canet‐Rodríguez MD9 | Maria Paz Pérez‐Espejo MD10 | Nuria Rodríguez‐Mias MD, PhD1 | Núria Sarasa‐Castelló MD3 | Marta Palau MD5 | Anabel Montero‐Armengol MD1 | Sabina Salicrú MD1 | Antonio Gil‐Moreno MD, PhD11,12,13 | Jose L. Poza MD, PhD1 1 Urogynecology and Pelvic Floor Unit, Department of Gynecology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain 2 General Surgery Research Group, Vall d'Hebron Institut de Recerca, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain 3 Pelvic Floor Unit, Department of Obstetrics and Gynecology, Hospital General de Granollers, Barcelona, Spain 4 Department of Gynecology, Hospital Quirón Sagrado Corazón, Sevilla, Spain 5 Department of Gynecology, Hospital Virgen del Rocío, Sevilla, Spain 6 Department of Gynecology, Hospital de Viladecans, Barcelona, Spain 7 Functional Urology and Urodynamics Unit, Department of Urology, Hospital Universitari de Bellvitge, Universitat de Barcelona, Barcelona, Spain 8 Department of Gynecology, Hospital de Mataró, Consorci Sanitari del Maresme, Barcelona, Spain 9 Department of Gynecology, Hospital Santa Caterina de Salt, Girona, Spain 10 Department of Urology, Hospital General de Riotinto, Huelva, Spain 11 Department of Gynecology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus., Barcelona, Spain 12 Biomedical Research Group in Gynecology, Vall d'Hebron Institut de Recerca, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain 13 Centro de Investigación Biomédica en Red (CIBERONC), Instituto de Salud Carlos III, Madrid, Spain Correspondence Jordi Sabadell, MD, Urogynecology and Abstract Pelvic Floor Unit, Department of Aims: To compare the effectiveness and safety of polypropylene (PP) and Gynecology. Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona polyvinylidene fluoride (PVDF) transobturator tapes (TOT) for the treatment Hospital Campus. Universitat Autònoma of female stress urinary incontinence (SUI). This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. © 2020 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals LLC Neurourology and Urodynamics. 2021;40:475–482. wileyonlinelibrary.com/journal/nau | 475 476 | SABADELL ET AL. de Barcelona, Passeig Vall d'Hebron 119‐129. E‐08035 Barcelona, Spain. Methods: This is a multicentre randomized trial. Women with SUI or stress‐ Email: jsabadell@vhebron.net predominant mixed urinary incontinence and scheduled for a TOT procedure were randomized to PP or PVDF slings. The primary outcome was 1‐year cure Funding information or improvement rate using composite criteria. Complications were also com- Fundación Dexeus Salud de la Mujer; pared. Relationships with outcomes were analyzed using multivariable logistic Cardiolink regressions models. Results: From April 2016 to January 2018 285 participants were randomized. PP and PVDF slings showed similar high cure or improvement rate (91.0% vs. 95.6%, p = .138). Improvement in validated questionnaires was also similar. PVDF slings were associated with a lower rate of de novo urgency incontinence (adjusted odds ratio = 0.35; 95% confidence interval = 0.15–0.80). We found no statistical differences in complications rates, although a higher incidence of long‐term pain events were observed in the PP group. The study is underpowered to find differ- ences in specific complications owing to the low number of events. Conclusion: PP and PVDF TOTs are equally effective, although PVDF is associated with fewer cases of de novo urgency incontinence. Further studies are needed to give robust conclusions on safety profiles. KEYWORDS de novo urgency incontinence, midurethral sling, polypropylene, polyvinylidene fluoride, PVDF, sling complications, stress urinary incontinence, suburethral sling, suburethral tape, transobturator 1 | INTRODUCTION In a previous descriptive clinical study we found si- milar effectiveness and complications with PP and PVDF One of the most common first line surgical treatments for slings, although more obstructive events were observed in female stress urinary incontinence (SUI) is currently the the PP group.15 However, to date there are no clinical use of tension‐free suburethral tapes. Both retropubic and trials comparing those materials in suburethral slings. For transobturator routes have shown a similarly high that reason we designed this randomized controlled trial effectiveness but with different complication profiles.1–5 (RCT) to establish whether PP and PVDF TOTs are Specifically, complication rates for transobturator tapes equally effective for treating female SUI. Secondarily, (TOT) ranged from 11% to 31%.6 It is well known that safety profiles will be compared. biomechanical and biocompatibility properties of the materials used in the slings are related to their success and complication rates.7–10 Therefore, some of the com- 2 | M A T E R I A L S AN D M E T H O D S plications that could be related to the sling's material, such as de novo urgency incontinence (UUI), pain, sling The present study was designed as a pragmatic, multi- extrusion and voiding dysfunction may be further centre RCT to compare the effectiveness of PP and PVDF decreased by improving this material. TOTs for the treatment of female SUI. Eleven Spanish Although many brands have developed their own slings, hospitals were initially included in the trial. The research the synthetic material utilized in these tapes is mainly poly- protocol was approved by the Ethics Committee of the propylene (PP). However, the use of polyvinylidene fluoride participating centers or explicitly accepted the approval of (PVDF) in suburethral tapes is also approved in Europe. the coordinating center in the absence of an own ethics PVDF is a nonabsorbable fluoropolymer introduced in 2002 committee. The protocol was registered at the public for surgical meshes 11 with improved biocompatibility in registry ClinicalTrials. gov (NCT02886520). animal studies.12,13 Some of its biomechanical properties are Patients attending at the participant hospitals because of lower elongation and deformation capacities compared with SUI or stress‐predominant mixed urinary incontinence PP.14 These characteristics are the basis to hypothesize that (MUI) were considered for participation in the study. PVDF slings may be associated with less mesh‐related Exclusion criteria were previous continence surgery with complications. midurethral slings, the presence of MUI with predominant SABADELL ET AL. | 477 urgency incontinence, intrinsic sphincter deficiency (de- than in the preoperative evaluation and an interview fined as maximal urethral closure pressure of 20 cmH2O or about symptoms of incontinence, use of urinary protec- less or as Valsalva leak point pressure of 60 cmH2O or less) tion, micturition difficulties, pain in groins or thighs and when it was evaluable, the existence of neurogenic bladder, dyspareunia. Patient satisfaction was assessed with the the incapacity to understand the information or to give patient global impression of improvement (PGI‐I) ques- their consent, and age less than 18 years. Women were tionnaire19 one year after surgery. Women also com- regarded eligible if they met the inclusion and exclusion pleted the Sandvik and ICIQ‐SF questionnaires at this criteria. All women received a detailed explanation about follow‐up point. the surgical procedure and the study, and written informed The primary outcome was the cure or improvement consent was obtained. rate one year after surgery, classified following a compo- Preoperative evaluation included a detailed physical site objective and subjective criteria. Patients were re- examination including a cough stress test (patients were garded as cured if they had no stress leaks, the stress test invited to attend follow‐up visits at least 2 h after the last was negative and they were fully satisfied with the micturition), an interview following a questionnaire with operation (Sandvik and ICIQ‐SF scores = 0, PGI‐I = 1–2). signs and symptoms of lower urinary tract dysfunction To be regarded as improved, the cough stress test had to based on the terminology recommended by the Interna- be negative and the patient moderately satisfied with the tional Continence Society,16 a urinalysis and urine cul- result of surgery due to sporadic stress leaks or to an in- ture. SUI was diagnosed clinically by the cough stress test crease in urinary frequency with or without sporadic UUI in all cases. Pelvic organ prolapse (POP) was staged using episodes (Sandvik and ICIQ‐SF > 0, PGI = 2–3). Patients the POP‐Q system. Preoperative urodynamic study before were classified as failures in the presence of a positive surgery was optional according to each center's protocol. cough test and/or dissatisfaction with the surgery, in- Participants also completed preoperatively the Sandvik's cluding de novo UUI and/or voiding dysfunction asso- incontinence severity index validated for Spanish ciated with frequent urinary infections and the use of the language and that categorizes incontinence into four same urinary protection during daily activities as before groups (a fifth group was defined for zero punctuation the surgery (PGI‐I ≥ 4). Intraoperative and postopera- that means no‐incontinence)17 and the International tive complications were also recorded. Early postoperative Consultation on Incontinence Questionnaire‐Short Form complications were defined as those that occurred within (ICIQ‐SF). the first month after surgery; late postoperative compli- A block‐randomization procedure, stratified by cen- cations were those that were present greater than 1 month ter, was carried out using a random number generator after surgery. De novo urgency was diagnosed clinically by program. Allocation was performed in a 1:1 ratio. the presence of new onset bothersome overactive bladder Randomization sequence was concealed in a centralized symptoms or by worsening of previous ones. Elevated electronic website designed specifically for this study post‐void residual volume was defined as a urine residual (http://www.ribk.com/C3PO/). Group assignment was of greater than 100 ml measured by introital ultrasound or performed before surgeries once participants agreed with by urethral catheterization. the study. Commercial kits of Amid Type‐I PP‐TOTs used Sample size calculation was based on the results of were those that each center used in their daily practice. our preliminary study with both materials15 and also The second material studied in TOTs was PVDF according to clinical relevance criterion. It was estimated (DynaMesh‐SIS direct soft; FEG Textiltechnik). All the that 282 patients were needed to provide 80% power to procedures were performed by experienced surgeons detect a 10% difference in success rate with an assumed with experience of both types of sling material. Patients cure rate of 95% for the reference procedure and a two‐ were not blinded for the procedure. TOT procedures sided α‐error of 0.05. were done following the standard technique18 and ac- Statistical analysis was conducted by a third party not cording to the instructions of the different brands, in- involved in the study. Normal distribution for continuous cluding the insertion routes. The tapes were placed variables was assessed using the Shapiro–Wilk test. tension‐free without the aid of a cough test. PP and Quantitative variables were compared using the unpaired PVDF slings were left under the midurethra in the same Student's t test and with the Mann–Whitney U test for manner, leaving a small distance between tape and ure- those variables that did not follow a normal distribution. thra by placing a scissor or a forceps between them. Categorical variables were analyzed using the χ2 test or Surgery for POP correction was associated when needed. Fisher's exact test when indicated. Outcomes analyses Postoperative follow‐up visits were scheduled at 1, 6 were performed on an intention‐to‐treat basis. A second (optional), and 12 months. These included physical ex- per‐protocol analysis for the primary outcome was pro- amination with a cough stress test in the same conditions jected. Univariate analyses were performed with each 478 | SABADELL ET AL. baseline variable by means of logistic regression. Multi- 3 | R ES U L T S variate logistic regression models were constructed for- cing them to keep the sling material and using a forward Between April 2016 and January 2018 a total of 307 pa- process based on the improvement of the likelihood and tients were assessed for eligibility. One of the 11 parti- the Akaike's criterion of the model with a p < .10 to de- cipating centers withdrew from the study before cide to include a new variable. Sensitivity for the primary including any participant. Patients' recruitment was outcome was evaluated using a shrinkage coefficient to stopped once the estimated sample size was reached. Of calibrate the model. One prespecified subgroup analysis them, 285 patients underwent randomization during the was planned on women with detrussor underactivity. study period, but one withdrew her consent to the study Changes in quantitative variables within‐procedures after having been randomized. Finally, 284 women were were analyzed by means of the Student's paired t test suitable for the analysis, 140 in the PP group and 144 in and differences in the changes between‐procedures were the PVDF one (Figure 1). Preoperative characteristics of compared with the unpaired t test. A two‐tailed p < .05 both groups were similar and are detailed in Table 1. In was considered to indicate statistical significance for the the PP group the TOT was inserted via the outside‐in analyses cited hereinbefore and 95% confidence intervals route in 123 women, whereas in the remaining 16 pa- (CIs) were calculated. Analyses were conducted with the tients the inside‐out route was used. All women in the software Stata version 15.1 (StataCorp) and SPSS version PVDF group underwent the TOT through the outside‐in 18.0 (IBM). approach. At the time of the surgery 73 women (25.4%) FIGURE 1 CONSORT flow diagram of the study. PP, polypropylene; PVDF, polyvinylidene fluoride SABADELL ET AL. | 479 TABLE 1 Baseline characteristics before surgery was the only variable associated with a PP PVDF p a failure of the procedure (odds ratio [OR] = 3.21, 95% b CI = 1.10–9.32). Concomitant POP surgery was not as- Age (years) 55.3 58.9 .133 (48.2–67.0) (50.1–68.1) sociated to failure (p = .785). Among failures (n = 18), 5 women (27.8%) underwent concomitant POP surgery BMIb 28.3 27.8 .683 while 13 (72.2%) did not. However, in the final multi- (25.6–31.9) (24.9–32.1) variate analysis the sling material was the only variable Parityb 2 (2–3) 2 (2–3) .607 included in the final model obtaining the same results Vaginal deliveriesb 2 (2–3) 2 (2–3) .548 (PVDF OR = 0.47, 95% CI = 0.17–1.28). The failures c observed in the PP group were because of persistent SUI Menopause 88 (62.9) 94 (65.3) .671 c in three cases, MUI in four cases, severe de novo urge Smoking habit .417 incontinence in four cases and voiding dysfunction in Nonsmoker 98 (71.5) 92 (65.3) one case. In the PVDF group 2 cases failed because of Former smoker 18 (13.1) 19 (13.5) persistent SUI and four cases because of MUI. Both the ICIQ‐SF and Sandvik scores improved after surgery with Current smoker 21 (15.3) 30 (21.3) PP and PVDF slings. Subjective improvement, assessed c Urethral hypermobility 112 (80.6) 107 (77.0) .463 with these questionnaires and the PGI‐I, was similar in Sandvik scoreb 8 (8–12) 8 (8–12) .399 both groups (Table 2). Calibrated model leads to a ICIQ‐SF b 16 (14–18) 16 (14–18) .332 shrinkage coefficient of 0.098 and therefore no correction c of the coefficients has been finally performed. Previous UUI 61 (44.2) 51 (36.9) .430 We conducted a per‐protocol analysis including c Associated POP 55 (39.3) 52 (36.4) .612 130 women in the PP group and 135 in the PVDF group. Associated surgery c 34 (24.5) 39 (27.3) .590 Results were materially unchanged, with an OR of failure in the PVDF group of 0.46 (95% CI = 0.17–1.26). Anterior repair 12 12 The subgroup analyses on patients with suspected Manchester procedure 0 1 detrussor underactivity included only 33 women. The Vaginal hysterectomy 5 8 observed results were similar to those on the whole study Vaginal hysterectomy + 13 13 population, with an OR of failure in the PVDF group of anterior and/or 0.25 (95% CI = 0.02–3.10). posterior repair Posterior repair 0 3 Colpocleisis 1 2 3.2 | Complications Other surgeries 3 0 Complications are detailed in Table 3. Seven women Abbreviations: BMI, body mass index; ICIQ‐SF, International Consultation (5.1%) experienced an intraoperative complication in the on Incontinence Questionnaire‐Short Form; PP, polypropylene; POP, pelvic PP group and four (2.8%) in the PVDF group. The sling organ prolapse; PVDF, polyvinylidene fluoride; UUI, urinary material was not associated with intraoperative compli- urge‐incontinence. a p Value comparing groups characteristic. cations on the multivariate model (PVDF OR = 1.10, 95% b Data expressed in median (interquartile range). CI = 0.97–1.25) as any other variable either. c Data expressed in n (%). Early postoperative complications were observed in 25 women in the PP group (18.1%) and 22 in the PVDF one (15.5%). In the multivariate analysis only the asso- underwent concomitant surgery for POP. During the ciated surgery to the TOT procedure was related to these 1‐year follow‐up period, 13 women (4.58%) were lost to complications (OR = 2.58, 95% CI = 1.26–5.28). Eight follow‐up. women (5.71%) in the PP group experienced voiding dysfunction with elevated post‐void residual volumes, one of them requiring sling loosening in the first days 3.1 | Primary outcome after surgery. In the PVDF group elevated post‐void re- sidual volumes were present in 10 women (6.94%). One On the intention‐to‐treat analysis the cure/improvement case of very early sling vaginal exposure was present in rate was similar with both sling materials: PP 91% each group. (122/134) versus PVDF 95.6% (131/137, p = .138). In the Late postoperative complications were recorded in 14 univariate analysis the presence of urge‐incontinence women (10.4%) in the PP group and 10 in the PVDF 480 | SABADELL ET AL. TABLE 2 Questionnaires scores Preoperative Postoperative p Within group PP PVDF PP PVDF PP PVDF p Between groups a ICIQ‐SF 16 (14–18) 16 (14–18) 0 (0–6) 0 (0–5) .000 .000 .149 a Sandvik 8 (8–12) 8 (8–12) 0 (0–3.75) 0 (0–3) .000 .000 .173 No UI 4 (2.9%) 4 (2.8%) 72 (54.5%) 76 (55.9%) Slight 3 (2.2%) 1 (0.7%) 20 (15.2%) 24 (17.6%) Moderate 26 (19.0%) 23 (16.3%) 32 (24.2%) 32 (23.5%) Severe 64 (46.7%) 66 (46.8%) 7 (5.3%) 3 (2.2%) Very severe 40 (29.2%) 47 (33.3%) 1 (0.8%) 1 (0.8%) a PGI‐I 1 (1–2) 1 (1–2) .757 Very much/much better 115 (89.1%) 122 (91.7%) Little better 7 (5.4%) 6 (4.5%) No change or worse 7 (5.4%) 5 (3.8%) Abbreviations: ICIQ‐SF, International Consultation on Incontinence Questionnaire‐Short Form; PGI‐I, patient global impression of improvement; PP, polypropylene; PVDF, polyvinylidene fluoride; UI, urinary incontinence. a Data expressed in median (interquartile range). TABLE 3 Complications group (7.2%). Neither overall late complication rate PP PVDF pa (PVDF OR = 0.64, 95% CI = 0.27–1.52) nor any specific Intraoperative 7 (5.1%) 4 (2.8%) .356 late complication was associated with sling material. Finally, we find a lower rate of de novo UUI in the PVDF Bleeding 1 (0.7%) 1 (0.7%) group with an adjusted OR = 0.35 (95% CI = 0.15–0.80; Vaginal perforation 4 (2.9%) 2 (1.4%) Table 3). Associated POP was not related to de novo UUI Other 2 (1.4%) 1 (0.7%) (p = .456). Among women who suffered de novo UUI, Early postoperative 25 (18.1%) 22 (15.5%) .452 6 (27.3%) underwent associated POP surgery whereas 16 women (72.7%) did not in the PP group (p = .753). In the Temporary elevated PVR 8 (5.8%) 10 (7.0%) PVDF group four women (40.0%) underwent associated b Cystitis 2 (1.4%) 3 (2.1%) POP surgery and six (60.0%) did not (p = .458). Sling Suburethral hematoma 2 (1.4%) 1 (0.7%) division was needed in three patients in the PP group Obturator/hypogastric pain 6 (4.3%) 4 (2.8%) (in 2 because of voiding dysfunction and in 1 because of vaginal extrusion) while none in the PVDF group, how- Vaginal exposition 1 (0.7%) 1 (0.7%) ever this difference was not significant (p = .121). Other 8 (5.8%) 4 (2.8%) Late postoperative 14 (10.4%) 10 (7.2%) .313 Repeated cystitis b 2 (1.5%) 5 (3.6%) 4 | D I S C US S I O N Voiding dysfunction 1 (0.7%) 1 (0.7%) There are no previous clinical trials comparing the ef- Tape extrusion 3 (2.2%) 2 (1.5%) fectiveness of PP and PVDF in midurethral slings for Obturator/hypogastric pain 7 (5.2%) 2 (1.5%) treating female SUI. The present study finds similar ef- fectiveness of both materials under the specified criteria. Dyspareunia 4 (3.0%) 1 (0.7%) The observed overall high success rates at 1 year are in Sling division 3 (2.2%) 0 (0%) .121 accordance with the results obtained in a previous ob- De novo urgency 22 (16.4%) 10 (7.3%) .012 servational study.15 However, no data are available on Abbreviations: PP, polypropylene; PVDF, polyvinylidene fluoride; PVR, long‐term outcomes comparing these materials. post‐void residual urine volume. Safety however, is also a major issue for surgical pro- a Adjusted p value according to final multivariable models. cedures. Safety of PVDF meshes in urogynecology has b Positive urinary culture. been reported previously.15,20,21 In the present trial, we SABADELL ET AL. | 481 observed a higher incidence of de novo UUI in the PP AC KNOW LEDGM ENTS group. This finding was also observed in our previous The authors would like to thank the Statistics and Bioin- descriptive study,15 and could be explained in part by the formatics Unit (UEB) from the Vall d'Hebron Institut de lower elongation and better biocompatibility of PVDF Recerca (VHIR) for their support in statistical analysis. than PP described in experimental studies.12–14 The This study was supported by a grant from Cardiolink amount of foreign body reaction and the consequent mesh restricted to the development of the centralized database contraction 13,22 could explain some cases of de novo UUI. for the study and by an unrestricted grant from Fundación In addition, the overall rates of de novo UUI are similar to Dexeus Salud de la Mujer that was destined to the those described previously.15,23 On the contrary, we have maintenance of the specific study's website. not found the differences in obstructive events observed previously,15 nor in other complications. However, a C O NF L I C T O F I N T E R E S T S higher number of adverse events that could be associated JL Poza has received a speaker honorarium from Astellas with the material used were observed in the PP group, Pharma outside the submitted work. The remaining such as long‐term pain, dyspareunia and the need for sling authors declare that they have no conflict of interests. division. Although the present study was designed to compare the effectiveness of the techniques, it is under- ORC ID powered to find differences in specific complications due Jordi Sabadell http://orcid.org/0000-0001-9380-0338 to the low number of events. This clinical trial compares these materials obtaining REFER ENCES robust data on their effectiveness as TOT slings. The 1. Ford AA, Rogerson L, Cody JD, Aluko P, Ogah JA. Mid‐ objective assessment based on the cough stress test was urethral sling operations for stress urinary incontinence in limited because it was not performed with a specified women. 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