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Introduction and Hypothesis: Following health notification by the FDA in 2008 of serious complications with transvaginal mesh for anterior pelvic organ prolapse, there has been a return to native tissue repairs. Earlier work with a self-retaining support (SRS) implant showed a high anatomical success rate with minimal implant-related complications over a medium-term follow-up. It is proposed that post-implant complications are more a consequence of the method of mesh anchoring rather than the implant itself. Our system incorporates an ultralight mesh with a frame that provides level I, II, and III support without the need for fixation. The first long-term outcomes of SRS implantation are presented., Methods: A prospective multicenter trial was conducted using two consecutive identical protocols of the use of the SRS implant in women with symptomatic anterior compartment prolapse extending their follow-up to 36 months. Anatomical success (Pelvic Organ Prolapse Quantification stage 0 or 1 or a Ba ≤ -2) was recorded along with subjective success as defined by regular quality-of-life (PFDI-20 and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) assessments., Results: Sixty-seven patients completed 36 months of follow-up. Mean Ba measurements improved from 3.1 (-1 to 6) cm to -2.8 (-1 to -3) cm and C point from 0.4 (-8 to 6) cm to -6.9 (-10 cm to 1) cm. accumulating to a significant anatomical success rate of 94.3%. Subjective success based on question #3 of the PFDI-20, analyzed for the index surgical compartment, reached 95.7%. Post-operative complications included 2 cases of urinary retention, 1 minor frame exposure, 1 case of delayed voiding dysfunction, and 2 cases of de novo stress urinary incontinence. Untreated pre-operative second-degree Bp measurements had increased in 27% at follow-up., Conclusion: The long-term outcome of the SRS implant shows an excellent subjective and objective success with minimal risk of complications or need for reintervention., (© 2021. The International Urogynecological Association.)

Introduction: This study investigated perioperative and mid-term clinical outcomes after laparoscopic sacrocolpopexy (LSCP) with light titanium-coated polypropylene (TCP) mesh in a large group of patients affected by International Continence Society stage II-IV pelvic organ prolapse (POP)., Methods: This multicenter retrospective study included 217 patients treated with LSCP using TCP mesh. We aimed to (1) analyze the intra- and postoperative complication rates according to the ICS/IUGA Complication Classification Code guidelines, (2) evaluate the anatomical results and (3) assess postoperative patient satisfaction with the Patient Global Impression Improvement questionnaire. Nonparametric Wilcoxon signed-rank tests, χ2 test and Fisher's exact test were used where appropriate., Results: The intraoperative complications were two (0.9%) cases of hemorrhage, two (0.9%) cases of incidental cystotomy and four (1.8%) cases of incidental colpotomy. During the postoperative follow-up, we recorded mesh exposure in 3 (1.4%) out of 217 patients. These 3 patients were from a group of 22 women who underwent vaginal opening during surgery, while in the remaining 195 patients without incidental colpotomy, no mesh exposure was observed (13.6% vs. 0.0%, p < 0.001). No failure of the apical compartment was observed, while 3 (1.4%) out of 217 patients experienced isolated anterior recurrence, and 1 (0.4%) patient had isolated posterior recurrence. All patients reported PGI-I scores ≥ 3, and 209 patients (96.3%) had a PGI-I score ≥ 2., Conclusions: The use of light TCP mesh is safe and effective during LSCP for POP repair from both an anatomical and a functional point of view, posing a very low postoperative mesh-related complication risk.

Introduction and Hypothesis: The present video shows a rare case of erosion through the full rectal wall into the rectum after a transperineal implant of a double-arm polypropylene kit., Methods: A 70-year-old woman underwent a transperineal implant of a double-arm polypropylene kit. One year after surgery, she developed bothersome symptoms in the posterior perineum including heaviness, pain and rectal bleeding during defecation. A clinical examination showed the presence of a part of the prothesis traversing the rectal cavity. A minimally invasive transanal approach was performed to remove the mesh and restore the rectal integrity., Results: This surgical technique demonstrates rectal mesh removal with a transanal approach., Conclusions: To our knowledge, this is a rare complication of rectal erosion of a posterior transperineal mesh kit. The aim of this video is to show a complete transanal approach to treating this serious complication avoiding the more invasive and traumatic abdominal procedure.

Introduction and Hypothesis: Uterovaginal prolapse treatment is a challenge for the urogynecologist. Surgical management for apical prolapse can be successful with native tissue and uterosacral ligament (USL) fixation. However, some complications have been described, especially with use of the vaginal approach. The aim of this video is to describe an alternative laparoscopic approach to a traditional vaginal procedure to reduce nerve injury and ureteral complications., Methods: A 75-year-old woman was referred to our unit for symptomatic stage III apical prolapse and underwent laparoscopic USL fixation, according to the technique described herein., Results: This surgical technique was successful in correcting apical prolapse., Conclusions: This video tutorial may be useful to urogynecologists for improving surgical technique, thus leading to a reduction in the risk of nerve and ureteral complications. The technique offers the possibility of a correct under-vision suture positioning. Laparoscopic USL fixation can be safely performed to treat apical prolapse.

Introduction and Hypothesis: The search for an improved vaginal mesh prompted the development of a new anchorless implant. The objective was to report on outcome after 2 years of a technique using a self-retaining support (SRS) implant., Methods: Patients with anterior vaginal wall prolapse, with/without apical prolapse, were recruited. Participants underwent surgical repair using the SRS device. Demographic data, pre-surgical Pelvic Organ Prolapse Quantification (POP-Q) scoring, quality of life (QoL) questionnaires (Pelvic Floor Distress Inventory Short Form 20 [PFDI-20], Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 [PISQ-12]), and surgical data were collected. Patients were followed at 2 weeks, 2, 6, 12, and 24 months after surgery. Objective anatomical success was defined using the NIH criteria., Results: Twenty women were recruited for the study with an average age of 62.1 years and an average parity of 4.0 deliveries. Average BMI was 28. Pre-operative mean POP-Q measurements were Aa =1.40 (-1 to 3) cm, Ba = 2.3 (-1 to 6) cm and C = 0.4 (-7 to 6) cm. Surgical time averaged 31.2 min. Estimated blood loss averaged 165 ml. No intra-operative complications were observed. One case (5%) of frame erosion was documented 8 months after surgery. At 2 years' follow-up, mean POP-Q measurements were: Aa = -2.95 (-3 to -2) cm, Ba = -2.85 (-3 to -2) cm, and C point -6.90 (-10 to -3) cm. Seventeen (85%) patients had stage 0 and 3 patients (15%) had stage 1. No mesh erosions or chronic pelvic pain were documented at follow-up. The total PFDI score at follow-up was decreased by 92.8 points (p < 0.0001)., Conclusions: At 2 years' follow-up, the SRS implant was found to be safe, showing no intra-operative or immediate post-operative complications. All women presented with POP-Q measurements of the anterior and apical compartment at normal value (Ba ≤ -2 cm) and statistically significant subjective improvement.

Over the past decade, a huge number of new implants and ancillary devices have been introduced to the market. Most of these have become clinically available with little or no clinical data or research. This is a less-than-ideal situation, and this subgroup of the ad hoc IUGA roundtable conference wants to open the discussion to change this, by proposing a pragmatic minimum clearance track for new products being introduced to the market. It consists of an accurate and more standardized product description, data on the biological properties gathered in animal experiments, anatomical cadaveric studies, and upfront clinical studies followed by a compulsory registry on the first 1,000 patients implanted. Ideally, manufacturers should support well-designed prospective (randomized) clinical trials that can support the claimed benefits of the new product.

Introduction and Hypothesis: This is an observational multicentre prospective study into the complications and effectiveness of TVT SECUR™., Methods: One hundred forty-seven patients with urodynamic or occult Stress Urinary Incontinence (SUI) were enrolled. Outcome measures at 6, 12 and 24 months were: objective cough test; subjective responses to PGI-S questionnaire and Visual Analogue Score., Statistical Analysis: Wilcoxon Test; Monte Carlo Exact Test., Results: Ninety-five urodynamic SUI and 41 occult SUI patients were treated using transobturator (H-position) or retropubic (U-position) approach (110 vs. 26 patients). Cure rates at 6, 12, and 24 months were 87.5%, 88.6% and 89.5%. Failure rates at all follow-ups were similar for urodynamic and occult SUI. The U-position failure rate was comparable to H-position at short-term but significantly higher at mid-term. Familiarity with the technique brought significantly higher success rates., Conclusions: TVT SECUR is safe, effective and versatile, but has an appreciable learning curve.

Introduction and Hypothesis: Our study compared high levator myorrhaphy (HLM) and uterosacral ligament suspension (USLS) for vaginal apex fixation from both an anatomical and functional point of view, and assessed the impact of surgery on quality of life (QoL) and sexuality., Methods: Two hundred twenty-nine patients with symptomatic stage >or=2 apical prolapse were randomized to USLS or HLM. Those patients who also needed cystocele repair additionally underwent an anterior prosthetic reinforcement. We defined as cure no prolapse of stage 2 or greater in any compartments according to the POP-Q system., Results: Correction of apical prolapse was observed in 96.6% of the HLM group and 98.3% of the USLS group. However, a persistent anterior wall prolapse occurred in 29.2% of the HLM group and in 35.4% of the USLS group. Both groups reported improvement in storage, voiding, and prolapse-related symptoms. Urodynamics of patients in the HLM group showed post-operative reduction in detrusor pressure at maximum flow and an increase in maximum flow. Both groups saw similar improvement in QoL. We did not encounter any serious side effects, except for nine cases of intraoperative ureteral occlusion following USLS., Conclusion: This study demonstrates similar efficacy of HLM and USLS for vaginal apex suspension; however, USLS has a higher incidence of complications involving the upper urinary tract.