Paravaginal bests xenograft for anterior prolapse.
There were no significant differences in symptomatic prolapse recurrence, operative time, or sexual function outcomes, Dr. Keisha Dyer said.
Recurrence rates of up to 40%-50% are commonly reported after anterior vaginal wall prolapse repair, with about 30% of these women requiring a reoperation, she said.
Although paravaginal repairs and graft augmentation can decrease the number of failures, more data are needed about the optimal material, said Dr. Dyer of the division of female pelvic medicine and reconstructive surgery at the University of California, San Diego.
Dr. Dyer and her associates assessed 99 women with symptomatic prolapse. In the operating room on the day of surgery, 32 were randomized to anterior colporrhaphy; 31, to porcine dermal graft; and the remaining 36, to polypropylene mesh.
At baseline, patients enrolled in this Optimal Anterior Repair Study (OARS) had a mean of stage III anterior prolapse and a mean age of 63 years. They were enrolled from January 2006 to September 2008. The researchers tracked patients' outcomes at 6 weeks and at 6, 12, and 24 months.
Dr. Dyer presented interim results for 78 women followed for at least 1 year (mean, 20 months) at the annual meeting of the American Urogyneco-logic Society.
Anatomic success was achieved by 14 of 26 women (54%) in the colporrhaphy group, 15 of 24 women (63%) in the porcine graft group, and 25 of 28 (89%) women in the synthetic mesh group. The difference in this primary outcome between the colporrhaphy and synthetic mesh groups was statistically significant, Dr. Dyer said. Anatomic success was defined as prolapse stage I or 0 on the pelvic organ prolapse quantification (POP-Q) examination.
There was no significant difference between groups in symptomatic recurrence, a secondary aim of the study. A total of 12% of the colporrhaphy group, 13% of the porcine graft group, and 4% of the mesh group had a return of prolapse symptoms, such as complaint of "bulge." Two patients in the porcine graft group had reoperations, Dr. Dyer said.
The erosion rate was higher in the synthetic mesh group. This outcome was experienced by four patients in this group (14%), compared with one patient (4%) who received the porcine graft repair.
There were no significant differences in terms of operative time. However, there was a trend toward approximately 50 mL more blood loss with augmentation, Dr. Dyer said. Estimated blood loss was 171 mL in the colporrhaphy cohort, 229 mL in the porcine graft group, and 225 mL in the synthetic mesh patients.
In terms of subjective outcomes, women in all three groups reported a reduction in prolapse and urinary symptoms at follow-up on subscales of the pelvic floor impact questionnaire (PFIQ) and the pelvic floor distress inventory (PFDI). There were no statistical differences between groups.
In addition, postoperative sexual function scores on the pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ) were not significantly different between groups, Dr. Dyer said.
The randomized, double-blind, multicenter design was a strength of the study, she said. 'A major limitation is that a majority of our subjects underwent concomitant procedures," which were permitted at the discretion of the surgeon.
"We look forward to sharing our 2-year data in the future," Dr. Dyer said. Time to failure and any differences in reports of pain are planned to be released with the 24-month data.
Major Finding: Paravaginal repair of anterior prolapse with synthetic mesh had a higher anatomic success rate than xenograft repair; both beat standard colporrhaphy at 1 year after surgery.
Data Source: Interim results of a double-blind, randomized, controlled study in 78 women with symptomatic prolapse.
Disclosures: The study was supported by an unrestricted grant from Boston Scientific Corp. Dr. Dyer and her coauthors said they had no relevant disclosures.
ARTICLES BY DAMIAN McNAMARA
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|Title Annotation:||WOMEN'S HEALTH|
|Publication:||Internal Medicine News|
|Date:||Feb 1, 2010|
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