NEW ORLEANS — A polypropylene mesh was found effective for repair of anterior vaginal prolapse, a 12-month, single-arm multicenter study showed.
In initial data from the ongoing prospective trial, 96 women with stage II or greater anterior vaginal wall prolapse who underwent placement of the mesh had stage I or less prolapse at 12 months' follow-up.
During placement of the mesh, the cystocele was not reduced or repaired. If additional reconstructive or incontinence repair was needed, it was completed at that time. Women with a history of anterior wall graft or concomitant hysterectomy were excluded, Dr. R.D. Moore, a gynecologic surgeon in private practice in Alpharetta, Ga., reported at the annual meeting of the Society of Gynecologic Surgeons.
The trial was funded by American Medical Systems of Minnetonka, Minn., maker of the Perigee system with IntePro mesh used in the study. All of the surgeons already had experience with using this macroporous type I soft polypropylene mesh.
Dr. Moore presented 12-month data on 96 of the 114 patients studied. Twenty-three percent (22) had prior cystocele repair, 87% (83) were postmenopausal, and 54% (52) had a prior hysterectomy. With the Perigee only, the procedure took about 29 minutes. If there was a concomitant repair, overall operative time averaged 87 minutes. Sixty-four percent (61) had a concomitant vault suspension, 70% (67) had an incontinence procedure, and 65% (62) had a rectocele repair.
Thirty-seven patients were discharged on the same day and 33 on day 1.
Follow-up was conducted at 6 weeks, 3 months, 6 months, 12 months, and 24 months. The mean follow-up was 18 months. Eleven patients (11%) had a mesh extrusion into the vagina, a mean of 133 days after surgery. Dr. Moore said this extrusion rate was consistent with findings in the literature for this type of material. Nine (9%) of the extrusion cases required surgical intervention; two (2%) healed with conservative treatment, including trimming of exposed mesh in the office. Not a single mesh system was removed to try to resolve an extrusion, said Dr. Moore.
Five (5%) patients had postoperative pain. Almost 3% of women reported de novo urge with incontinence and dyspareunia, but those cases all resolved. One patient had a reoperation for a device system failure.
The researchers looked to see whether use of vaginal estrogen postoperatively had any protective effect, and found that it did not change the extrusion rate, said Dr. Moore.
There was a significant improvement in all the quality of life scales used. And there was a decrease in dyspareunia, from 46% (44) to 31% (29) at the 12-month mark. Sexual activity remained consistent, with 52% (50) of women reporting they were active.
Despite its limitation as a single-arm study, the trial did show consistent and good anatomic results and minimum morbidity, said Dr. Moore. He said he expected to report data soon on the 2-year follow-up.
Dr. Moore disclosed that he received honoraria, and speaking and teaching fees from American Medical Systems. He also is on some AMS advisory committees.
In discussing the paper, Dr. Charles R. Rardin of Brown University, Providence, R.I., lauded the study for its relatively large numbers, but said the lack of a comparison group hindered its conclusions. Also, he said there were no data on women who were implanted but excluded from follow-up, and he was also concerned that results for women who had concomitant apical suspension might be confounding. He questioned whether the results were generalizable, given that the procedures in the trial were conducted by experienced surgeons.
Dr. Rardin made no disclosures.
Dr. Moore replied that the results were not likely to be reproducible in the general surgeon population, and suggested it was up to the Society of Gynecologic Surgeons and other professional groups to determine whether there should be minimum qualifications for conducting mesh procedures.