Objectives: The objective of the study was to assess the effectiveness and complication rates for the transvaginal (TVM) technique in the treatment of pelvic organ prolapse (POP).
Methods: Women with symptomatic POP (POP-Q stage II-IV) were invited to participate in this institutional review board-approved 5-year study at 3 US centers. All enrolled patients underwent prolapse repair surgery with GYNEMESH PS Prolene Nonabsorbable Soft Mesh using the TVM technique. Success was defined as International Continence Society (ICS) POP-Q stage I or less. The Prolapse-Specific Inventory and quality-of-life questionnaire was used as a subjective outcome measure.
Results: Eighty-five women were included. Sixty-six patients were available for follow-up at 5 years. Overall anatomic success rates were 88% (90% confidence interval [CI], 80%-93%), 69% (90% CI, 59%-78%), and 67% (95% CI, 56%-76%) at 1, 3, and 5 years, respectively. Anatomic success rates in treated compartments were 89% (90% CI, 82%-94%), 76% (90% CI, 66%-84%), and 77% (90% CI, 67%-85%) at 1, 3, and 5 years, respectively. When defined as treated side leading edge above the hymen, success rates were 89% at 5 years. Five patients required reoperation for prolapse by 5 years. Statistically significant improvements in quality-of-life and Prolapse-Specific Inventory scores were sustained over 5 years. Mesh exposure was observed in 16 of 85 patients over the 5 years. Nine required partial mesh excision. There were 3 patients with some degree of dyspareunia, reported between 3 and 5 years, whereas in 8, preexisting dyspareunia resolved. There was 1 rectovaginal fistula reported and 2 reported ureteral injuries, one of which resulted in a ureteral-vaginal fistula; all resolved after repair.
Conclusions: Five-year results indicated that TVM provided a stable anatomic repair. Improvements in quality of life and associated improvements in specific prolapse symptoms were sustained over the 5-year period. Mesh exposure was the most common complication.