Effectiveness of Self-cut vs Mesh-Kit Titanium-Coated Polypropylene Mesh for Transvaginal Treatment of Severe Pelvic Organ Prolapse: A Multicenter Randomized Noninferiority Clinical Trial.

Importance: Transvaginal mesh (TVM) can increase the durability of vaginal surgical procedures for pelvic organ prolapse (POP) and may be indicated in certain situations despite concerns about mesh-related complications. In addition, the expense of commercial mesh kits has limited their use. The effectiveness, safety, and cost of a self-cut mesh procedure compared with a commercial mesh-kit procedure for the surgical treatment of women with POP is unclear. Objective: To assess the 1-year effectiveness and safety of self-cut titanium-coated polypropylene mesh compared with a precut commercial mesh kit for the transvaginal surgical treatment of women with severe symptomatic POP. Design, Setting, and Participants: This multicenter randomized noninferiority clinical trial was conducted at 11 hospitals in 8 provinces of China. A total of 336 women with symptomatic stage 3 to 4 POP were enrolled between January 22, 2018, and November 11, 2019, with follow-up through December 11, 2020. Interventions: Participants were randomized to receive a TVM procedure using either self-cut mesh (self-cut mesh group) or a precut commercial mesh kit (mesh-kit group), both of which used the same titanium-coated polypropylene mesh. Main Outcomes and Measures: The primary outcome measure was composite surgical success at 1 year, which was defined as the absence of vaginal bulge symptoms, no additional retreatment for POP, and no vaginal prolapse at or beyond the hymen. Secondary outcomes included symptom-specific pelvic floor function and quality-of-life measures as well as perioperative complications, including mesh-related complications and hospitalization costs. Complications were categorized using the Clavien-Dindo system (with grade 1 indicating any deviation from the normal postoperative course but not requiring grade 2-4 interventions; grade 2, need for pharmacological treatment, blood transfusion, and/or total parenteral nutrition; grade 3, the need for surgical, endoscopic, and/or interventional radiological procedures; and grade 4, life threatening). Results: Among 336 female participants (mean [SD] age, 63.3 [5.9] years; all of Chinese ethnicity), 169 patients were randomized to the self-cut mesh group, and 167 were randomized to the mesh-kit group. Three patients were unavailable for follow-up after 1 year. In the intention-to-treat analysis, 162 women (95.9%) in the self-cut mesh group had outcomes that met the definition of surgical success; this result was noninferior to the surgical success rate observed in the mesh-kit group (146 women [87.4%]; risk difference, 8.5%; 95% CI, 2.2%-14.3%; P = .006). The frequency of Clavien-Dindo grade 1 to 3 perioperative complications was not significant between groups (12 of 166 women [7.2%] in the self-cut mesh group vs 20 of 161 women [12.4%] in the mesh-kit group; P = .14). Vaginal mesh exposure rates in women examined at 1 year were similar (4 women [2.4%] in the self-cut mesh group vs 8 women [4.8%] in the mesh-kit group; P = .23). Median (IQR) total hospitalization costs were $3663.00 ($3258.90-$4495.10) in the self-cut mesh group vs $6144.00 ($5434.90-$7160.20) in the mesh-kit group (P < .01), representing savings of $2481.00 (40.4%) with the use of self-cut mesh. Conclusions and Relevance: In this clinical trial, the composite surgical success rate of a self-cut mesh procedure was noninferior to that of a commercial mesh-kit procedure using the same titanium-coated polypropylene mesh and reduced hospitalization expenses by 40.4%. These findings suggest that the use of self-cut mesh procedures may be advantageous for the surgical treatment of some women with severe POP, particularly those in countries with low and middle income. Trial Registration: ClinicalTrials.gov identifier: NCT03283124.

The impact of partially absorbable midurethral slings in stress urinary incontinence surgery: A cohort study.

OBJECTIVE: To evaluate the performance of retropubic midurethral slings (MUS) for the treatment of female stress urinary incontinence (SUI) at a certified continence center and to identify risk factors for sling failure. METHODS: This was a single-center cohort study including women who underwent a retropubic MUS procedure for SUI between 2012 and 2019 with a follow up of 12 months. Primary end point was cure of SUI assessed using the validated questionnaire International Consultation of Incontinence Questionnaire-Urinary Incontinence-Short Form. Univariate and multivariate analyses were applied to identify risk factors for sling failure. Wilcoxon signed-rank tests were used as paired samples tests. The significance level was set at 5%. RESULTS: A total of 662 women with a median age of 65 years (interquartile range 19 years) were included in the investigation; 523 (79.0%) presented with complicated SUI. Cure was reported by 213 (32.2%) women. Independent predictors for failure were obesity, pharmacotherapy for overactive bladder, postoperative sling adjustment, and use of partially absorbable mesh, which was correlated with a 56% decrease in the odds for achieving cure. CONCLUSION: This investigation questions the role of partially absorbable mesh for stress urinary incontinence procedures and scrutinizes the use of implants with inadequate clinical evidence.

3 Year outcome after treatment of uterovaginal prolapse with a 6-point fixation mesh.

INTRODUCTION: The aim of this study was to describe the intermediate outcome of a single-incision 6-point fixation transvaginal mesh for the treatment of primary and recurrent pelvic organ prolapse (POP). STUDY DESIGN: This was a prospective cohort study including consecutive patients undergoing POP repair with the InGYNious anterior transvaginal mesh. Inclusion criteria were women with symptomatic stage II POP or higher. Exclusion criteria were the unwillingness or inability to give written informed consent, malignant diseases, neuro-muscular disorders, chronic pain syndrome or previous radiation in the pelvis. Every study participant completed a structured questionnaire, a urogynecological examination according to the IUGA-ICS POP-Q staging system and the validated P-QoL questionnaire before the operation and three years postoperatively. RESULTS: 254 patients were included into the study, 179 were available for the three-year follow-up (70 %). Sixteen patients (8.2 %) had undergone reoperation for recurrent or de novo prolapse (12/16 patients underwent reoperation in the posterior compartment) and were excluded from the objective outcome analysis. In the final study group, all POP-Q measurements, urge urinary incontinence and voiding dysfunction were significantly improved. The de novo SUI rate was 27/ 120 (23 %) in women without reoperation for SUI and/ or POP and without primary SUI. No serious adverse events occurred. Four (1.5 %) patients had mesh exposure at the one-year follow-up and been treated with local oestrogen. At three-year follow-up, no new mesh exposure was seen. De novo dyspareunia rate was low (n = 5 (3 %)). CONCLUSIONS: In this study, the objective outcome three years after anterior POP repair with the InGYNious transvaginal mesh was good. The reoperation rate both for mesh related problems or prolapse were rare.

The international discussion and the new regulations concerning transvaginal mesh implants in pelvic organ prolapse surgery.

The use of transvaginal mesh implants for POP and urinary incontinence is currently being extensively debated among experts as well as the general public. Regulations surrounding the use of these implants differ depending on the country. Although in the USA, the UK, in Canada, Australia, New Zealand, and France, transvaginal mesh implants have been removed from the market, in most mainland European countries, Asia, and South America, they are still available as a surgical option for POP correction. The aim of this review is to provide an overview of the historical timeline and the current situation worldwide, as well as to critically discuss the implications of the latest developments in urogynecological patient care and the training of doctors.

Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial.

BACKGROUND: Pelvic organ prolapse (POP) is a common health problem and has significant negative effects on a woman's quality of life. The transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our previous case-series study showed that the use of self-cut mesh had a good success rate (91.8% at 1-year follow-up) and low complication rate. This trial is designed to compare a self-cut titanium-coated polypropylene mesh procedure with a mesh kit for the treatment of symptomatic stage III-IV anterior or apical prolapse in terms of efficacy, safety and cost-effectiveness. METHODS: The trial is a randomized controlled multicenter non-inferiority trial. The primary outcome measure is the composite success rate at 1-year follow-up. The secondary outcomes are anatomic outcomes of each vaginal segment (anterior, posterior and apical) using the POP-Q score, subjective improvement of quality of life according to questionnaires, intraoperative parameters, complications and costs. Analysis will be performed according to the intention-to-treat principle. Based on a comparable success rate of 90% and 10% as the margin (ß = 0.2 and one-sided α = 0.025), about 312 patients in total from 11 centers will be recruited including 10% dropout. The aims of the research are to demonstrate whether the self-cut mesh procedure is non-inferior to the mesh-kit procedure and to investigate the performance of titanium-coated mesh for vaginal prolapse repair. DISCUSSION: This multicenter non-inferiority trial will evaluate whether the efficacy and safety of self-cut mesh is non-inferior to mesh kits in women with severe symptomatic stage III-IV anterior or apical prolapse. If we are able to show that the self-cut mesh procedure is non-inferior to the mesh-kit procedure in success rates, then the self-cut mesh procedure may be more cost-effective. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03283124. Registered on 17 January 2018.

Significant Improvement in Quality of Life, Positive Effect on Sexuality, Lasting Reconstructive Result and Low Rate of Complications Following Cystocele Correction Using a Lightweight, Large-Pore, Titanised Polypropylene Mesh: Final Results of a National, Multicentre Observational Study.

Introduction Patients who suffer from pelvic organ prolapse can experience severe limitations in their quality of life. To improve the quality of life of women affected and achieve a stable reconstruction, surgical therapy is often indispensable. In conventional prolapse surgery, the rate of recurrence is high. For this reason, alloplastic mesh has been implanted increasingly in recent years to reconstruct the anatomy of the pelvic floor organs. Even if the anatomical result can be significantly improved as a result, the mesh-induced complications have been the subject of controversial discussion. In this national, multicentre study, the quality of life, anatomical result as well as the rate of complications following the implantation of an alloplastic mesh for the correction of a cystocele were investigated. Method Fifty-four patients with symptomatic ≥ grade II were included in this prospective, national, multicentre study. The study participants were implanted with a titanised polypropylene mesh (TiLOOP ® PRO A, pfm medical ag). The follow-up observation period was 12 months. Primary as well as repeat procedures were taken into account. The anatomic result of the pelvic floor reconstruction was quantified using the POP-Q system. Data on quality of life and sexuality were collected using validated questionnaires. All complications which occurred were documented and evaluated by an independent committee. Results On average, the patients were in line with the census. An improvement in quality of life was able to be determined during the study in all domains investigated (p < 0.001, Wilcoxon test). Minus incorrect entries and incorrect reports, a total of 19 reports of adverse events in 15 patients were evaluated by the end of the study. The rate of recurrence in the anterior compartment was 4.3%. Conclusion In the reconstruction of the anatomical position of the pelvic floor organs given the presence of a symptomatic cystocele, the implantation of a third-generation alloplastic mesh achieves very good results. Affected patients benefit from the anatomical stability as well as a significant improvement in quality of life, whereby the risks are justifiable.

Pelvic organ prolapse patients' attitudes and preferences regarding their uterus: comparing German- and Russian-speaking women.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare preferences of patients with pelvic organ prolapse (POP) regarding their uterus between German- and Russian-speaking areas. METHODS: Six urogynecologic tertiary referral centers participated in this prospective study: three centers from German-speaking countries and three from different regions of Russia. To assess the uterus-related preferences as well as the attitude toward hysterectomy versus uterus-sparing prolapse surgery, we developed a structured questionnaire that included 5-point Likert scales related to benefit of uterus (BOU) and benefit of not having uterus (BNU). Each scale consisted of 12 items (range of possible scores: 12-60). Finally, patients were asked if they preferred uterus removal or preservation when undergoing prolapse surgery. RESULTS: One hundred and seventy-eight German-speaking and 206 Russian-speaking patients were included in the study. There was no significant difference in patients' preference before undergoing POP surgery regarding uterus preservation versus hysterectomy between German- and Russian-speaking patients: 40% of German-speaking and 54% of Russian-speaking patients preferred to retain their uterus before undergoing POP surgery. Comparison of BOU mean scores showed a significant difference between groups: 20.6 ± 6.7 for German-speaking compared with 32.5 ± 9.1 for Russian-speaking patients (p < 0.01). The Russian-speaking group had significantly higher mean scores on domains sexuality, body image, and partnership of the BOU scale (2.6 ± 1.0 vs. 1.8 ± 0.9 for sexuality; 2.4 ± 1.1 vs. 1.5 ± 0.7 for body image, and 2.6 ± 0.9 vs. 1.6 ± 0.7 for partnership domains; p < 0.05). CONCLUSIONS: Although a large proportion of German- and Russian-speaking patients prefers uterus preservation when undergoing prolapse surgery, the uterus was more important for sexuality, partnership, and body image in Russian-speaking patients.

1-year outcome after treatment of uterovaginal prolapse with a 6-point fixation mesh.

INTRODUCTION: The aim of this study was to describe the safety and anatomical results of a surgical approach with a single-incision 6-point fixation vaginal mesh for the treatment of pelvic organ prolapse at perioperatively and at 1-year follow-up. MATERIALS AND METHODS: This was a prospective observational study of patients who underwent operation receiving an InGYNious anterior transvaginal mesh. All patients with symptomatic stage II prolapse or higher were included in the study. Exclusion criteria were the unwillingness or inability to give written informed consent, neuromuscular disorders, malignant diseases, previous radiation in the pelvis, or chronic pain syndrome. Every patient completed a structured questionnaire and a full physical examination according to the IUGA-ICS POP-Q staging system before the operation and at 1-year follow-up. RESULTS: Two hundred fifty-four patients (91%) were included in the study. The intraoperative complication rate was 7% with hemorrhage being the most common complication. Six patients (2.4%) had undergone reoperation for prolapse (four out of the six patients had reoperation in the posterior compartment) and were excluded from the objective outcome analysis. In the remaining 248 patients all POP-Q measurements were significantly improved in the anterior and apical compartments. Similarly, urge urinary incontinence and voiding dysfunction improved significantly. CONCLUSIONS: In this series, the objective outcome one year after the InGYNious mesh was good with low numbers of mesh-related problems or reoperation for prolapse.

Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months.

INTRODUCTION: Pelvic organ prolapse can significantly reduce quality of life of affected women, with many cases requiring corrective surgery. The rate of recurrence is relatively high after conventional prolapse surgery. In recent years, alloplastic meshes have increasingly been implanted to stabilize the pelvic floor, which has led to considerable improvement of anatomical results. But the potential for mesh-induced risks has led to a controversial discussion on the use of surgical meshes in urogynecology. The impact of cystocele correction and implantation of an alloplastic mesh on patients' quality of life/sexuality and the long-term stability of this approach were investigated. METHOD: In a large prospective multicenter study, 289 patients with symptomatic cystocele underwent surgery with implantation of a titanized polypropylene mesh (TiLOOP ® Total 6, pfm medical ag) and followed up for 36 months. Both primary procedures and procedures for recurrence were included in the study. Anatomical outcomes were quantified using the POP-Q system. Quality of life including sexuality were assessed using the German version of the validated P-QoL questionnaire. All adverse events were assessed by an independent clinical event committee. RESULTS: Mean patient age was 67 ± 8 years. Quality of life improved significantly over the course of the study in all investigated areas, including sexuality and personal relationships (p < 0.001, Wilcoxon test). The number of adverse events which occurred in the period between 12 and 36 months after surgery was low, with just 22 events reported. The recurrence rate for the anterior compartment was 4.5%. Previous or concomitant hysterectomy increased the risk of recurrence in the posterior compartment 2.8-fold and increased the risk of erosion 2.25-fold. CONCLUSION: Cystocele correction using a 2nd generation alloplastic mesh achieved good anatomical and functional results in cases requiring stabilization of the pelvic floor and in patients with recurrence. The rate of recurrence was low, the patients' quality of life improved significantly, and the risks were acceptable.

Correction of cystocele and stress incontinence with anterior transobturator mesh.

OBJECTIVE: To evaluate the effectiveness and safety of anterior transobturator mesh for treating cystocele with or without urinary stress incontinence. STUDY DESIGN: Eighty-five women with cystocele, with or without USI, underwent anterior transobturator vaginal mesh operation. All patients were examined after 4 months. Seventy-two of them were evaluated via questionnaire after 7 months with respect to complications, the effectiveness of the operation and its influence on their quality of life. Women with urinary stress incontinence in addition to cystocele (62.5%) underwent suburethral mesh placement with the anterior mesh-arms used like a transobturator sling. RESULTS: Recurrence of stage 1 cystoceles were seen in 9.6% of patients but no recurrence of symptomatic cystocele was observed. Mesh erosion of the central anterior vaginal wall appeared in 5.9%. Three revisions but no mesh explantation became necessary. Urinary stress incontinence was cured in 83.3%, while it improved in 9.3%. Urge incontinence was cured in 28.6% of patients and improved in 17.5%. De novo urge incontinence occurred four times and de novo urinary stress incontinence was found in three patients. Among sexually active women, 27% reported improved intercourse, while 24.3% reported a change for the worse. Quality of life improved in 81.9%, and 95.8% would undergo the procedure again. CONCLUSION: Anterior transobturator mesh is a safe method to treat cystocele with or without stress urinary incontinence and yields good initial results.

Surgical repair of posterior compartment prolapse: preliminary results of a novel transvaginal procedure using a four-armed polypropylene mesh with infracoccygeal and pararectal suspension.

BACKGROUND: Anatomical defects of the posterior vaginal compartment are a common reason for pelvic floor reconstructive surgery. The implantation of a four-armed monofilamentous polypropylene mesh with infracoccygeal and pararectal suspension is a recently introduced innovative technique, which is believed to reduce the risk of mesh retraction and prolapse recurrences, and additionally, allows a tension-free adjustment of the mesh. METHODS: In this preliminary case series, we aimed to evaluate feasibility, intraoperative complications and short-term follow-up results of this novel surgical procedure in a multicentre approach. Seventy-three patients undergoing surgery for posterior vaginal compartment prolapse were enrolled. The mean follow-up time was 3.8 months (range: 2-6 months), and follow-up information was available in 60/73 (82.2%) women. RESULTS: Intraoperative complications were observed in 4.2% of cases, 2 patients with blood loss >500 ml, and one bladder injury occurring during concomitant anterior compartment surgery. Importantly, there were no intraoperative complications directly related to the implantation technique (e.g. rectum perforations), and no prolapse recurrences at follow-up examinations 3-6 months postoperatively. Our short-term mesh erosion rate was 3.1%. CONCLUSIONS: We conclude that this innovative procedure is a feasible and safe technique for the treatment of posterior vaginal compartment prolapse. Further prospective and multicentre trials are warranted.