Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial.

AIMS: To evaluate the safety and efficacy of the Uphold LITE mesh in the treatment of pelvic organ prolapse at 12-month follow-up. METHODS: Women undergoing a mesh surgery due to an anterior prolapse plus a symptomatic anterior prolapse (classed as pelvic organ prolapse quantification stage ≥2) were included in this prospective, multicentre, observational study. The primary endpoint was a composite outcome including a good anatomical correction, no prolapse symptoms, and no reintervention for an anterior or apical recurrent prolapse within 12 months of surgery. Secondary outcomes included safety, improvements in quality of life (QoL), and risk factor for recurrence. This study was registered with ClinicalTrials.gov, number NCT01559168. RESULTS: A total of 121 patients were included. Symptomatic and anatomic cure rates were 94% (95 of 101) and 76.8% (76 of 99), respectively. The composite success rate was 72.4% (71 of 98). The rate of reoperation for apical or anterior recurrent prolapse was 3.9% (4 of 103). Anatomical anterior or apical recurrence occurred in 18.2% (18 of 97) and 7.2% (7 of 97) of patients, respectively. The composite success rate was significantly higher in centres where more than 30 patients had been treated (80% vs 50%; P = .045). The rate of serious complication was 5.4% (6 of 111). Improvements were recorded in QoL including sexual function. CONCLUSIONS: The Uphold LITE mesh procedure provides satisfactory outcomes in the treatment of anterior and apical prolapse, particularly in high-volume centres. The rates of adverse effects and reintervention for recurrent prolapse were acceptable.

A retrospective comparison of two vaginal mesh kits in the management of anterior and apical vaginal prolapse: long-term results for apical fixation and quality of life.

INTRODUCTION AND HYPOTHESIS: To compare apical correction in stage ≥3 cystocele between two mesh kits. METHODS: This was a retrospective, nonrandomized study that compared two groups matched on anterior/apical POP-Q stage: 84 received Elevate Ant™ single-incision mesh (Elevate Ant group) and 42 Perigee™ transvaginal mesh (Perigee group). Follow-up at 1 and 2 years comprised objective (POP-Q) and subjective (PFDI-20, PFIQ-7, PISQ-12) assessments. The primary endpoint was objective success: 2-year apical POP-Q stage ≤1. Secondary endpoints were anterior POP-Q stage, subjective results and complications. RESULTS: Groups were comparable in terms of age (66.6 and 64.7 years, respectively; p = 0.19), BMI (both 25.4 kg/m2; p = 0.93), and history of hysterectomy (7.2 % and 14.3 %; p = 0.21) or prolapse surgery (12 % and 14.3 %; p = 0.72). Operative time was shorter in the Elevate Ant group (54.1 vs. 62.5 min; p = 0.048), and the 2-year objective apical success rate was higher (92.9 % vs. 66.7 %; p < 0.0001), with better point C correction (-5 vs. -3.8; p = 0.006). Function improved in both groups, with significantly better PFIQ-7 (p = 0.03) and PFDI-20 (p = 0.02) scores in the Elevate Ant group at 2 years. Vaginal exposure was not seen in the Elevate Ant group but occurred in two patients in the Perigee group (p = 0.33). Factors associated with success were age >65 years (OR 7.16, 95 % CI 1.83 - 27.97) and treatment with Elevate Ant mesh (OR 10.16, 95 % CI 2.78 - 37.14). Postoperative stress urinary incontinence rate was greater with the Elevate Ant group (29.8 % and 16.7 %; p = 0.11). CONCLUSIONS: The use of the Elevate Ant mesh was associated with significantly better apical correction at 2 years. Function improved in both groups, but with a significantly better PFDI-20 score in the Elevate Ant group at 1 and 2 years. The postoperative stress urinary incontinence rate, however, tended to be greater in the Elevate Ant group. The results need confirming with longer follow-up of these cohorts and in randomized studies.

Outpatient vaginal surgery for pelvic organ prolapse: a prospective feasibility study.

BACKGROUND: In the light of recent progress in pelvic organ prolapse surgery, the modalities of hospital admission need reconsidering. This work aims to assess success rate of outpatient (ambulatory) vaginal mesh surgery for genital prolapse. METHODS: A prospective observational study was conducted between January 2015 and July 2017, including all patients presenting with POP-Q stage ≥3 anterior and/or apical prolapse. RESULTS: Sixty-nine of the 89 eligible patients were treated on an ambulatory basis (group A); 20 required overnight admission (group B): i.e., ambulatory success rate, 77.5%. Mean operative time was 44.9±2.5 min in group A and 62±6.5 min in group B. Reasons for ineligibility for ambulatory management comprised organizational issues at home (10.5%) and excessive home-to-hospital distance (5.7%). The postoperative urinary retention rate was 4.5%. Rates for successful cystocele correction (POP-Q <2) at 2 months were similar in the two groups: 94.2% in group A and 94.4% in group B (P=ns). Mean satisfaction score was 8.6±0.3/10. CONCLUSIONS: Outpatient anterior vaginal mesh surgery for prolapse is safe and effective. The current medical-economic context favors ambulatory management. Patient selection, prior information and continuity of care seem primordial.

Prospective feasability study of ambulatory surgery for pelvic organ prolapse.

STUDY OBJECTIVE: The aim of this study was the evaluation of ambulatory surgery (AS) rate for pelvic organ prolapse (POP). DESIGN: It was a prospective observational study. DESIGN CLASSIFICATION: Level II-2. SETTING: Patients were divided in two groups: Group EAS: patients eligible to ambulatory surgery and Group NEAS: patients not eligible to AS. PATIENTS: all patients from August 2015 to November 2016 undergoing surgery for POP in our institution. MEASUREMENTS: The main outcome was overall AS rate in the population. Secondary outcomes were in NEAS group: reasons for ineligibility; in EAS group: AS success rate, reasons of failure and patient satisfaction related to AS; in each group: post operative re-admission or consultation, morbidity and global satisfaction. MAIN RESULTS: There was 157patients included in the study. Eligibility criteria for AS was met for 111/157 (707%). Overall AS rate was 58% and success rate of AS was 82%. Reasons for ineligibility to AS were lack of home support (50%), home >1 h from hospital (109%), poor home conditions (2,2%), associated comorbidity (21.7%), associated procedure (4,3%) and refusal for AS (109%). Reasons for failure (20/111, 18%) of AS were unsuccessful trial of void (TOV) (65%), post operative nausea-vomiting (PONV) (15%), sub-cutaneous emphysema (5%), post-operative bleeding (5%) and faulty organization (10%). There was no unscheduled re-admission the night after surgery in EAS group. 7,2% in EAS group and 13% in the NEAS group had an unscheduled consultation. There were 4 re-admissions (3,6%) in the EAS group and 1 (2,2%) in the NEAS group during follow-up. Patient satisfaction to AS was 100% on next-day call and 923% at 6 weeks. CONCLUSION: Ambulatory surgery rate was 58% in this population of surgically managed prolapses; AS success rate was 82%. There was no adverse events related to AS and patient satisfaction to AS at 6 weeks is high.

Long-term follow-up of patients treated by transvaginal mesh repair for anterior prolapse.

OBJECTIVE: The aim of the study was to assess 5 years outcome of transvaginal single incision mesh surgery (SIMS) for anterior pelvic organ prolapse (POP). STUDY DESIGN: This was a prospective study including all patients from January 2009 to December 2012 who underwent SIMS for symptomatic anterior prolapse stage ≥2, according to POP Quantification (POP-Q). Symptoms and quality of life were assessed using validated questionnaires: Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact questionnaire (PFIQ-7), and Prolapse/ Incontinence Sexual Questionnaire (PISQ-12). Main outcome was subjective success (question 3 of PFDI-20 score = 0). Mesh-related complications, objective and functional outcomes were used as the secondary outcomes. RESULTS: 270 patients were included in the study. Median follow-up was 5,7 years [4,5-8,2]. Subjective success rate was 86,6% at 5 years. Objective success rate was 53,1% at 5 years. At 5 years, composite failure (subjective + objective) occurred for 17 patients (12%), 7 patients with direct recurrence and 10 with indirect recurrence. Re-treatment was performed in six patients (2,8%; 3 hysterectomies for apical recurrence and 3 posterior repairs for posterior recurrence). One case (0,4%) of asymptomatic mesh exposure occurred. The reoperation rate for mesh-related complications was 3,4%. At 5 years, de novo dyspareunia rate was 11,7%, 3,9% considered as mesh-related. A significant improvement was noted for symptoms and quality of life. CONCLUSION: Five-year results demonstrate that vaginal mesh surgery provides a durable and safe repair of anterior compartment prolapse with a low rate of mesh-related complications and reoperations. Between the 2- and 5-year follow-up, patient satisfaction and associated improvements in prolapse-specific symptoms were sustained and minimal new morbidity occurred.

Two years follow up of 270 patients treated by transvaginal mesh for anterior and/or apical prolapse.

OBJECTIVE: The aim of this study was to assess the 1 and 2 years outcomes of transvaginal single incision mesh surgery (SIMS) for anterior pelvic organ prolapse (POP). MATERIAL AND METHODS: This was a prospective study including all patients from November 2008 to December 2012 who underwent SIMS for symptomatic anterior prolapse stage≥2, according to the POP Quantification (POP-Q). Symptoms and quality of life were assessed using validated questionnaires: Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact questionnaire (PFIQ-7), and Prolapse/Incontinence Sexual Questionnaire (PISQ-12). The main outcome was subjective success (question 3 of PFDI-20 score=0). Safety, anatomic and functional outcomes were used as the secondary outcomes. RESULTS: A total of 270 patients were included in the study. Subjective success rate was 95,4% and 92,2% at 1 and 2 years. Objective success rate was 65,9%and 60,5% at 1 and 2 years. At 1year, composite failure (subjective+objective) occurred for 11 patients (4,6%), 5 patients with direct recurrence and 6 with indirect recurrence. At 2 years, composite failure was reported for 14 patients (6,4%): 6 direct recurrences and 8 indirect recurrences. Re-treatment was performed in one case (0,4%). One case (0,4%) of asymptomatic mesh exposure occurred. The reoperation rate for mesh-related complications was 3%. We reported a de novo dyspareunia rate of 8,4%, 5,3% considered as mesh-related. A significant improvement was noted for symptoms and quality of life. CONCLUSION: POP repair using SIMS is a safe and efficient treatment of anterior compartment prolapse in the medium term with a low rate of mesh-related complications. Longer-term follow-up is ongoing.

Elevate anterior/apical: 12-month data showing safety and efficacy in surgical treatment of pelvic organ prolapse.

OBJECTIVE: This study aimed to assess the safety and efficacy of the Elevate Anterior/Apical transvaginal mesh procedure in pelvic organ prolapse (POP) repair at 12-months follow-up. METHODS: This prospective, multicenter, multinational study enrolled 142 patients experiencing anterior vaginal prolapse with or without apical descent (POP-Q ≥ stage II). Each patient received a single-incision transvaginal polypropylene mesh implantation anchored to the sacrospinous ligaments bilaterally. Primary outcome was treatment success defined as POP-Q less than or equal to stage I at 1 year using the Last Failure Carried Forward method. Secondary outcomes included validated quality-of-life measures. Fourteen subjects who received a concomitant posterior apical support procedure were excluded from the analysis. RESULTS: Of the 128 subjects, 112 (87.5%) completed the 12-months follow-up. The mean age was 64.7 years. The anatomic success rate was 87.7% (95% confidence interval, 80.3%-93.1%) for the anterior compartment and 95.9% (95% confidence interval, 88.5%-99.1%) for the apical compartment. POP-Q measurements (Aa, Ba, and C) improved significantly (P < 0.001) with no significant changes to TVL (P = 0.331). Related adverse events reported at greater than 2% were mesh exposure (8; 6.3%), urinary tract infection (7; 5.5%), transient buttock pain (5; 3.9%), de novo stress incontinence (5; 3.9%), retention (5; 3.9%), dyspareunia (3; 3.2%), and hematoma (3; 2.3%). All quality-of-life scores significantly improved from baseline (P < 0.001). CONCLUSIONS: Twelve-month data show that Elevate Anterior/Apical support procedure completed through a single vaginal incision yields favorable objective and subjective outcomes.

How to advise a woman who wants to get pregnant after a sub-urethral tape placement?

Our objective was to make recommendations for the follow-up of pregnancies and the choice of delivery route for patients becoming pregnant after surgical treatment of stress urinary incontinence (SUI) by tension-free vaginal tape (TVT) or trans-obturator tape (TOT). We performed a retrospective survey on pregnancies after surgical treatment of SUI. Nineteen physicians out of 3,400 contacted reported a total of 20 pregnancies after TVT or TOT. Three patients had recurrent SUI during pregnancy. No major complications of the tape occurred during pregnancy. Ten patients out of 20 delivered vaginally, and nine had a caesarean section. Mean follow-up after delivery was 13.8 months (1 to 52). Recurrence of SUI was observed in 3 of 20 (15%) during pregnancy and in 3 of 18 (16.7%) after delivery. The global rate of recurrence was 4 of 18 (22.2%). Recurrence of SUI was two of ten cases after vaginal delivery (20%) and in one of eight after caesarean section (12.5%; p=0.58). Vaginal delivery did not increase the risk of recurrence.