'H'-sling for prolapse repair appears safe, effective

August 1, 2006

Atlanta-An approach to transvaginal total pelvic reconstruction that uses a single piece of polypropylene mesh with four-point fixation is proving to be safe and efficacious during long-term follow-up, according to an outcomes analysis undertaken by urologists at North Shore-Long Island Jewish Medical Center, New Hyde Park, NY.

Surgeons have named the procedure the "H-sling mesh technique" because the synthetic mesh is fashioned into an H-shape that can be fixed at four points to afford tension-free support of the mid-urethra, bladder, vaginal vault, and anterior vaginal wall.

In a retrospective study of 96 consecutive patients operated on from January 2000 to June 2005, data from a telephone survey of 76 of the women were supplemented with chart review. Thirty-six women had undergone hysterectomies at the time of prolapse repair.

"In a previously published paper, we reported 5-year outcomes showing that polypropylene mesh was safe and efficacious when used in a tension-free synthetic sling technique for stress urinary incontinence. Subsequently, we reported encouraging results during short-term follow-up using this material in our novel technique for transvaginal repair of complete prolapse," Dr. Eisenberg said.

"The H-sling mesh allows concomitant repair of pelvic organ prolapse and stress urinary incontinence in a minimally invasive approach that is not too technically challenging," he said. "With lengthening follow-up, the efficacy and safety continue to be favorable, and despite concerns relating to the use of synthetic mesh, there have been no urethral or bladder erosions."

The H-sling mesh technique was introduced by Gopal H. Badlani, MD, the primary surgeon for all cases in the study.

Results of the retrospective analysis showed four women (5.2%) developed recurrence, and 68 women (89%) reported being completely or almost dry on a modified Urogenital Distress Inventory (UDI-6) questionnaire. Among 36 patients with stress urinary incontinence preoperatively, a statistically significant reduction in average daily pad usage, from 2.1 to 0.8, was seen (p<.005).

New-onset urge incontinence occurred in 12 women (15.7%). Of 21 sexually active patients, only two (9.6%) reported any dyspareunia. Mean score for overall patient satisfaction was 7.9 on a scale of 1 (least satisfied) to 10 (most satisfied).

Long-term complications that emerged during follow-up included a single case of urethrolysis. In addition, two women (2.1%) developed vaginal mucosal erosions that were treated with excision of the exposed mesh and raising of vaginal flaps for repair. In 1 year of follow-up, neither woman developed further erosion. A fourth patient underwent excision of a retained vaginal suture.

Resolving erosion concerns

Dr. Eisenberg explained that, despite concerns that synthetic mesh is associated with erosion and infection, the decision to use that material stems from a theory suggesting an underlying biochemical basis for the development of stress urinary incontinence, organ prolapse, and the relatively high failure rates of surgical repair techniques that rely on the patient's anatomy alone for success.

"Our laboratory data show there is an increase in systemic and localized activity of elastase and collagenase in these women that leads to a decrease in collagen in pelvic supporting tissue and structures in the vaginal vault," Dr. Eisenberg said.

The urologists said they use the BioArc Sling System (American Medical Systems, Minnetonka, MN) for their procedures because it features a special wing connection that allows placement of the support material in any configuration required.