Safety of Vaginal Mesh Surgery Versus Laparoscopic Mesh Sacropexy for Cystocele Repair: Results of the Prosthetic Pelvic Floor Repair Randomized Controlled Trial.

BACKGROUND: Laparoscopic mesh sacropexy (LS) or transvaginal mesh repair (TVM) are surgical techniques used to treat cystoceles. Health authorities have highlighted the need for comparative studies to evaluate the safety of surgeries with meshes. OBJECTIVE: To compare the rate of complications, and functional and anatomical outcomes between LS and TVM. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized controlled trial from October 2012 to April 2014 in 11 French public hospitals. Women with cystocele stage ≥2 (pelvic organ prolapse quantification), aged 45-75 yr, without previous prolapse surgery. INTERVENTION: Synthetic nonabsorbable mesh placed in the vesicovaginal space, sutured to the promontory (LS) or maintained by arms through pelvic ligaments (TVM). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Rate of surgical complications ≥grade II according to the modified Clavien-Dindo classification at 1 yr. Secondary outcomes were reintervention rate, and functional and anatomical results. RESULTS AND LIMITATIONS: A total of 130 women were randomized in LS and 132 in TVM; five women withdrew before intervention, leaving 129 in LS and 128 in TVM. The rate of complications ≥grade II was lower after LS than after TVM, but did not meet statistical significance (17% vs 26%, treatment difference 8.6% [95% confidence interval, CI -1.5 to 18]; p=0.088). The rate of complications of grade III or higher was nonetheless significantly lower after LS (LS=0.8%, TVM=9.4%, treatment difference 8.6% [95% CI 3.4%; 15%]; p=0.001). LS was converted to TVM in 6.3%. The total reoperation rate was lower after LS but did not meet statistical significance (LS=4.7%, TVM=10.9%, treatment difference 6.3% [95% CI -0.4 to 13.3]; p=0.060). There was no difference in symptoms, quality of life, improvement, composite definition of success, anatomical results rates between groups except for the vaginal apex and length, and dyspareunia (in favor of LS). CONCLUSIONS: LS is a valuable option for primary repair of cystocele in sexually active patients. LS is safer than TVM, but may not be feasible in all cases. Both techniques offer same functional outcomes, success rates, and anatomical outcomes, but sexual function is better preserved by LS. PATIENT SUMMARY: Our study demonstrates that laparoscopic sacropexy (LS) is a valuable option for primary repair of cystocele. LS offers equivalent success rates to vaginal mesh procedures, but is safer with a lower rate of complications and reoperations, and sexual function is better preserved.

Tension-free vaginal tape (TVT) in the treatment of urinary stress incontinence: 3 years experience involving 256 operations.

OBJECTIVES: To report the outcome and complications of a series of tension-free vaginal tape (TVT) operations and compare the results with the literature. MATERIALS AND METHODS: A total of 256 cases with a minimum follow-up time of 3 months (May 1998-September 2001) were included (193 isolated TVT, 23 combined with vaginal hysterectomy and 63 combined with prolapse surgery). These cases included 21% of the patients presenting with mixed incontinence, 14% with sphincter deficiency and 9.8% with recurrent incontinence. The isolated TVT were carried out under local anesthesia an ambulatory procedure, the others were done under spinal anesthesia. RESULTS: Almost all the patients underwent a clinical check-up after 3 months and 1 year and also underwent urodynamic exploration; they were then questioned by means of a questionnaire after 2 and 3 years. The global cure rate was 90, 91, 83 and 87%, respectively. The authors observed 6.4% of recurrences between 3 months and 1 year and 7.2% between 2 and 3 years. For mixed incontinence at the three first check-ups, the cure rate was 75, 85 and 60%, respectively, with 7.4 and 20% of recurrences between these two intervals. The cure rates of the patients who had presented with sphincter deficiency were 76, 79 and 73%, respectively, with 16% recurrences during the first year. In the case of recurrent incontinence, a cure was obtained in 72 and 71% of cases, with 18% of recurrences. The complications consisted of 5.5% cases of perforated bladder, 0.4% hematomas of the Retropubic space, 3.1% urinary infections, 0.4% urethral injuries, 5.1% transient urine retention, 12.0% de novo urinary urgency and 20% de novo dysuria. It should be noted that half of the pre-operative urgencies had disappeared after the operation. No defective healing and rejection phenomenon was observed. DISCUSSION: The authors reviewed the results reported in 35 articles, and compare these with their own results. They also reviewed all the complications encountered, account for them and suggested how they can be avoided. There are discrepancies between the various studies, particularly with regard to the complications. CONCLUSION: This minimally invasive operation should be further assessed so that it can demonstrate its effectiveness, and become the "Gold standard". Randomized studies are awaited with this in view.