Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse.

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT00566917.).

• Authors: Daniel Altman, Tapio Väyrynen, Marie Ellström Engh, Susanne Axelsen, Christian Falconer, Nordic Transvaginal Mesh Group
• Journal: The New England journal of medicine (N Engl J Med) Vol. 364 Issue 19 Pg. 1826-36 (May 12 2011) ISSN: 1533-4406 [Electronic] United States
• PMID: 21561348 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Aged
• Female
• Gynecologic Surgical Procedures (methods)
• Humans
• Logistic Models
• Middle Aged
• Pelvic Organ Prolapse (surgery)
• Postoperative Complications
• Surgical Mesh
• Treatment Outcome
• Urinary Bladder (injuries)
• Vagina (surgery)