BTCanada

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 Description: ≥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

Citation(s):

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.

Altman D, Väyrynen T, Engh ME, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group.

Collaborators (59)

Source

Division of Obstetrics and Gynecology, Department of Clinical Science, Danderyd Hospital, Stockholm, Sweden. daniel.altman@ds.se

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.).


------------------------------------------------------------------------------------------------------------------------

New Clues to Pregnancy-Associated Breast Cancer

FRIDAY, April 2 (HealthDay News) — Inflammation-related genes that are more likely switched on after pregnancy may be linked to pregnancy-associated breast cancer, U.S. researchers have discovered.

Getting pregnant at a young age reduces the long-term risk of breast cancer, but women are at increased risk for breast cancer during pregnancy and for up to 10 years after giving birth. These pregnancy-associated breast cancers are highly aggressive, said the University of Illinois at Chicago team.

They analyzed the level of expression of 64 genes in tissue from women aged 18 to 45 who had had benign breast biopsies and breast reduction surgeries. The researchers found that 22 percent of the genes showed significant differences in expression in the breast tissue of women who had never given birth and those who had children. Inflammation-related genes were more active in women who had given birth.

“Our results showed an increase in immune/inflammatory activity in the post-pregnant breast. Interestingly, this response was not limited to the recently pregnant group, but also characterized more distant pregnancies as well,” lead researcher Debra Tonetti, an associate professor of pharmacology, said in a news release.

The study, published in the March issue of Cancer Prevention Research, may help lead to new prevention and treatment approaches to pregnancy-related breast cancer.

— Robert Preidt

SOURCE: University of Illinois at Chicago, news release, March 29, 2010

Last Updated: April 02, 2010

--------------------------------------------------------------------------------------------------


NEXT