Summary and Comment
Mesh vs. Traditional Colporrhaphy for Anterior Vaginal Prolapse
Trocar-guided transvaginal mesh kits were more effective but were associated with a higher rate of adverse events.
Anterior vaginal prolapse (cystocele) repair is the most common surgical treatment for pelvic-organ prolapse in U.S. women. Recurrence rates of 40% following traditional repair (colporrhaphy) have spurred development of new techniques involving synthetic materials that have yielded mixed results (
JW Womens Health Aug 19 2010). Trocar-guided transvaginal polypropylene-mesh kits are now widely used, but clinical data are limited. In a partially manufacturer-supported multicenter trial, investigators in the Nordic Transvaginal Mesh Group randomized 389 women with symptomatic anterior vaginal defects to traditional colporrhaphy or to repair using transvaginal mesh kits (Gynecare Prolift Anterior Pelvic Floor Repair System; Ethicon). The primary outcome was treatment success as defined by a composite of objective anatomical outcomes (stage 0 or stage 1 prolapse) and subjective absence of vaginal bulging symptoms at 12 months.
The composite primary outcome was achieved in 61% of participants in the mesh group and 34% in the colporrhaphy group (P<0.001). However, duration of surgery was significantly longer (53 minutes vs. 34 minutes) and intraoperative blood loss was significantly greater (85 mL vs. 35 mL) in the mesh group. Bladder perforation (3.5% and 0.5%) and new-onset stress urinary incontinence (12% and 6%) also were more common in the mesh group, but the differences were not significant. Within 12 months, additional surgery to correct mesh exposure was required in six women; five other women in the mesh group underwent surgery for stress incontinence. One patient in the colporrhaphy group underwent surgery for recurrent prolapse.
Comment: These results show that trocar-guided mesh kits for cystocele repair have better 1-year success rates than does traditional colporrhaphy, although this benefit is offset by higher rates of intra- and postoperative adverse events. We await longer-term risk–benefit follow-up; in the meantime, this study's rigorous inclusion criteria, emphasis on uniform repair techniques, follow-up by independent examiners, and evaluation of both objective and subjective outcomes as well as a broad range of adverse events, go a long way toward putting this particular mesh product through the paces that, some would argue, should have been required before FDA approval and subsequent mass-marketing to gynecologists.
— Brent E. Seibel, MD
Dr. Seibel is an Assistant Professor of Obstetrics and Gynecology at the University of Florida College of Medicine–Jacksonville and has expertise in the evaluation and management of women with pelvic floor prolapse. He has no disclosures regarding companies that manufacture or market synthetic mesh for vaginal reconstructive surgery.
Published inJournal Watch Women's Health May 26, 2011
Altman D et al. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med 2011 May 12; 364:1826.
Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse.
Division of Obstetrics and Gynecology, Department of Clinical Science, Danderyd Hospital, Stockholm, Sweden. email@example.com
The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy.
In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocar-guided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery.
Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P<0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P=0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P=0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group.