The IUGA/ICS classification of synthetic mesh complications in female pelvic floor reconstructive surgery: a multicenter study.

INTRODUCTION AND HYPOTHESIS: The objective was to report patterns of sling and transvaginal mesh-related complications using the IUGA/ICS classification of prosthesis-related complications. METHODS: This was a retrospective chart review of all patients who underwent surgical removal of sling, transvaginal mesh, and sacrocolpopexy for mesh-related complications from 2011 to 2013 at three tertiary referral centers. The International Urogynecological Association (IUGA)/International Continence Society (ICS) classification system was utilized. RESULTS: We identified 445 patients with mesh complications, 506 pieces of synthetic mesh were removed, and 587 prostheses-related complications were classified. 3.7 % of patients had viscus organ penetration or vaginal exposure as their presenting chief complaint and 59.7 % were classified as not having any vaginal epithelial separation or category 1. The most common category was spontaneous pain (1Be: 32.5 %) followed by dyspareunia (1Bc: 14.7 %). The sling group was 20 % more likely to have pain compared with the pelvic organ prolapse (POP) mesh group (OR 1.2, 95 % CI 0.8-1.6). The most commonly affected site (S2) was away from the suture line (49 %). Compared with the sling group, the POP group had a higher rate of mesh exposure, which mostly occurred at the suture line area. The majority of patients presented with mesh-related complications more than 1 year post-insertion (T4; average 3.68 ± 2.47 years). CONCLUSION: Surgeons should be aware that patients with vaginal mesh complications routinely exhibit complications more than 1 year after the implantation with pain as the most common presenting symptom.

Single-incision vaginal approach to treat cystocele and vault prolapse with an anterior wall mesh anchored apically to the sacrospinous ligaments.

INTRODUCTION AND HYPOTHESIS: The safety and early efficacy of a new technique to treat cystocele and/or concomitant apical prolapse through a single vaginal incision with a lightweight mesh anchored apically bilaterally to the sacrospinous ligaments is reported. METHODS: Women with anterior compartment and/or apical prolapse ≥ stage II underwent repair through a single anterior vaginal wall incision with the Anterior Elevate System (AES). The technique utilizes a lightweight (24 g/m(2)) type I mesh anchored to the sacrospinous ligaments via two mesh arms with small self-fixating tips. The bladder neck portion of the graft is anchored to the obturator internus with similar self-fixating tips. The apical portion of the graft is adjustable to vaginal length prior to locking in place. Outcome measures included prolapse degree at last follow-up visit, intra/post-operative complications, and QOL assessments. RESULTS: Sixty patients were implanted with average follow-up of 13.4 months (range 3-24 months). Mean pre-op Ba was +2.04 ± 1.3 and C -2.7 ± 2.9. Average blood loss was 47 cc and average hospital stay was 23 h. Sixty-two percent of patients had concomitant sling for SUI. Mean post-op Ba is -2.45 ± 0.9 and C -8.3 ± 0.9. There was no statistical difference in pre- to post-op TVL. Objective cure rate at current follow-up is 91.7% (≤ stage 1). To date, there have been no mesh extrusions. No patients have reported significant buttock or leg pain. No patients have required surgical revision for any reason. CONCLUSION: The AES is a minimally invasive technique to treat anterior compartment and/or apical prolapse through a single vaginal incision. Initial results show the procedure to be safe and early efficacy is promising. Longer-term follow-up is ongoing.

Nonsurgical transurethral radiofrequency collagen denaturation: results at three years after treatment.

Objective. To assess treatment efficacy and quality of life in women with stress urinary incontinence 3 years after treatment with nonsurgical transurethral radiofrequency collagen denaturation. Methods. This prospective study included 139 women with stress urinary incontinence due to bladder outlet hypermobility. Radiofrequency collagen denaturation was performed using local anesthesia in an office setting. Assessments included incontinence quality of life (I-QOL) and urogenital distress inventory (UDI-6) instruments. Results. In total, 139 women were enrolled and 136 women were treated (mean age, 47 years). At 36 months, intent-to-treat analysis (n = 139) revealed significant improvements in quality of life. Mean I-QOL score improved 17 points from baseline (P = .0004), while mean UDI-6 score improved (decreased) 19 points (P = .0005). Conclusions. Transurethral collagen denaturation is a low-risk, office-based procedure that results in durable quality-of-life improvements in a significant proportion of women for as long as 3 years.

Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18-month results from a prospective long-term study.

AIMS: To evaluate 18-month safety and durability of efficacy of nonsurgical transurethral collagen denaturation as treatment for stress urinary incontinence (SUI) in women. METHODS: Study comprised women with SUI due to bladder outlet hypermobility for at least 12 months who failed conservative treatment and had not undergone surgery or bulking agent treatment. This one-time procedure was performed in a physician's office or ambulatory treatment center. Patients kept voiding diaries and completed the Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), and Patient Global Impression of Improvement measures at baseline and at 3, 6, 12, and 18 months posttreatment. RESULTS: At 18 months, intent-to-treat analysis revealed that patients experienced significant reductions in the median number of stress leaks daily (0.43; P < 0.006) and weekly (3.0; P < 0.006) versus baseline, with 46.7% reporting a 50% or greater reduction in leakage. Mean I-QOL score improved 10.9 points (median 8.5; P < 0.0001), with 47.8% having a 10-point or greater improvement and 50.4% reporting improved symptoms versus baseline. Mean UDI-6 improvement was 13.0 points, with a stress incontinence subscore improvement of 17.0 points. Overall, 47.0% of patients were "somewhat" or "very" satisfied, and 52.9% would recommend the procedure to a friend. The procedure was shown to be safe and effective, with no new treatment-related adverse events reported at 18 months. CONCLUSIONS: Transurethral collagen denaturation resulted in significant improvements in stress leaks and quality of life for at least 18 months. This procedure offers a safe, effective, nonsurgical treatment option for women with SUI.

Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 12-month results from a prospective long-term study.

STUDY OBJECTIVE: To assess efficacy of nonsurgical transurethral collagen denaturation (Renessa) in women with stress urinary incontinence (SUI) caused by bladder outlet hypermobility. DESIGN: Continuing, prospective, 36-month, open-label, single-arm clinical trial. Twelve-month results from intent-to-treat (ITT) analysis are reported. Canadian Task Force classification II-2. SETTING: Thirteen physician offices or ambulatory treatment centers. PATIENTS: Women with SUI secondary to bladder outlet hypermobility for 12 months or longer who failed earlier conservative treatment and had not received earlier surgical or bulking agent therapy. INTERVENTIONS: Women were treated as outpatients and received an oral antibiotic and local periurethral anesthesia before undergoing treatment with transurethral radiofrequency collagen denaturation. MEASUREMENTS AND MAIN RESULTS: Voiding diaries and in-office stress pad weight tests yield objective assessments. Subjective measures include the Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), and Patient Global Impression of Improvement (PGI-I) instruments. In total, 136 women received treatment (ITT population). Patients experienced significant reductions versus baseline in median number of leaks caused by activity/day and activity/week (p <.0026 for both), with 50% of patients reporting 50% or more reduction. Pad weight tests revealed that 69% of women had 50% or more reduction in leakage (median reduction 15.2 g; p <.0001); 45% were dry (29% no leaks; 16% < 1-g leakage). Significant improvements occurred in median scores on the I-QOL (+9.5 [range -66.0 to 91.0]; p <.0001) and mean scores on the UDI-6 (-14.1 +/- 24.7; p <.0001). Furthermore, 71.2% showed I-QOL score improvement, including 50.3% with 10-point or greater improvement, and 49.6% reported on the PGI-I that they were "a little," "much," or "very much" better. CONCLUSION: At 12 months, treatment of SUI with nonsurgical transurethral collagen denaturation resulted in significant improvements in activity-related leaks and quality of life.