By Charlotte Libov
HOLLYWOOD, Fla -- October 1, 2009 -- A 6-month follow-up study has found a device for apical and posterior vaginal defect repair to be effective in the treatment of pelvic organ prolapse, with acceptable risk, according to new research presented at the 30th Annual Scientific Meeting of the American Urogynecologic Society (AUGS).
The device utilises self-fixating tips for safe, simple, and precise mesh placement in the sacrospinous ligament through a minimally invasive single vaginal incision.
The report was presented here on September 26 by James Lukban, MD, Eastern Virginia Medical School, Norfolk, Virginia, who noted that the 6-month data are part of an ongoing, prospective, multicentre study involving 16 domestic and European urogynaecologic, urologic, and gynaecologic sites.
This study involved 139 patients (mean age 62.1 years) with posterior vaginal prolapse (stage 2 or greater) and/or apical or uterine descent (stage 2 or greater) who received the device with type 1 polypropylene mesh. Mesh insertion was through a single vaginal incision into the rectovaginal space, affixed without tension to the sacrospinous ligaments employing self-fixation tips.
The primary endpoint of this study was the percentage of subjects with stage 1 or lower ("cure") at follow-up. Patients were seen postoperatively at 6 weeks, 3 months, and 6 months, and will be followed through 2 years.
At baseline, 96.4% of subjects presented with posterior vaginal prolapse, 47.5% had posterior enterocele, and 30.9% had apical or uterine descent. The median procedure time for placing the device only was 42 minutes (15- to 127-minute range). The median estimated blood loss was 50 cc (5- to 340-cc range).
A single intraoperative complication occurred, in the form of injury to the rectum during initial dissection; there were, however, no untoward sequelae.
Anatomic "cure" was seen in 94.5% (120/127) and 95.1% (39/41) of subjects with posterior vaginal and apical prolapse, respectively. One patient receiving the device for posterior prolapse without an apical defect at baseline exhibited advanced cervical descent at follow-up.
Vaginal exposure of mesh was reported in 5.8% of subjects with no device explants.
Additional device-related adverse events included haematoma without transfusion in 3 patients (2.2%), dyspareunia in 2 patients (1.4%), constipation in 3 patients (2.2%), wound separation without extrusion in 2 patients (1.4%), buttock pain in 2 patients (1.4%), and vaginal infection in 2 patients (1.4%), with all other adverse effects at or below 1%.
Significant improvement was seen in all quality-of-life instruments, including the Pelvic Floor Distress Inventory and Colorectal-Anal Distress Inventory subscales of the Pelvic Floor Distress Inventory-Short Form 20; the Pelvic Organ Prolapse Impact Questionnaire and Colo-Rectal-Anal Impact Questionnaire subscales of the Pelvic Floor Impact Questionnaire-Short Form 7; and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12).
Forty-three percent (25/58) and 35% (20/57) of subjects reported no dyspareunia at baseline and 6 months, respectively (PISQ-12, question 5). On a patient-satisfaction survey, 97.7% felt they achieved "some" (21.9%) or "a lot of" (75.8%) improvement, and 99.2% would recommend this type of surgery to a friend.
"The study found very good anatomic durability, and very good quality-of-life improvement with high patient satisfaction," Dr. Lukban said. "There will be follow-up for 2 years for anatomic durability, and to make sure the extrusion rate is stable."
Funding for this study was provided by American Medical Systems.
[Presentation title: A Prospective Multi-Center Clinical Trial Evaluating Elevate Apical and Posterior (Elevate A&P) for Treatment of Posterior and/or Apical Vaginal Wall Prolapse: Six Month Follow-Up. Paper 82]
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