CHARLESTON, S.C. – Cure rates and patient satisfaction following vaginal prolapse repair were high at 3-year follow-up regardless of whether vaginal mesh or native tissue was used for the repair, according to findings from a prospective randomized trial.
The findings raise questions about the long-term value of vaginal mesh repairs because subjects treated with mesh had more complications without experiencing benefit beyond that observed in the native tissue repair patients, Dr. Robert E. Gutman reported at the annual meeting of the Society of Gynecologic Surgeons.
Dr. Robert Gutman
Of 65 women who were enrolled in the trial before enrollment was halted because of a 15.6% mesh exposure rate, 51 – including 25 in the mesh group and 26 in the no mesh group – had quality of life data available for the planned 3-year final analysis, and 41 had 2- or 3-year pelvic organ prolapse quantification (POP-Q) examination information available.
No differences were noted between the groups with respect to POP-Q stage or individual POP-Q points at 3 years, and the majority in both the mesh and no mesh groups (90% and 86%, respectively) improved in stage from baseline, said Dr. Gutman of MedStar Washington Hospital Center and of the department of obstetrics and gynecology and urology at Georgetown University, both in Washington.
Furthermore, no differences were seen between the groups with respect to symptomatic improvement as assessed by the Pelvic Floor Distress Inventory (PFDI), the Pelvic Floor Impact Questionnaire (PFIQ), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ), including subscale scores. Also, cure rates – using a variety of definitions for cure – did not differ between the groups.
For example, based on a POP-Q stage of 1 or less as a definition of cure, 45% and 43% of those in the mesh and no mesh groups, respectively, were cured. When no prolapse beyond the hymen was used as a definition, 85% and 71% were cured When absence of bulge symptoms (a "no" answer to item 3 on the PFDI) was used as a definition, 92% and 81% were cured. The differences between the groups for these and other definitions – including a rating of very much better or much better on the Patient Global Impression of Improvement Index (PGI-I), having no prolapse reoperation, and composite outcomes using various combinations of these definitions – were not statistically significant, Dr. Gutman said.
Of note, no new mesh exposures occurred between the previously reported 1-year analysis (three cases required surgical excision before 1 year) and the 3-year analysis. The only prolapse reoperation after 1 year was in a woman who also had a reoperation prior to the 1-year analysis, he said at the meeting, which was jointly sponsored by the American College of Surgeons.
Also of note, the anatomic cure rate was lowest for the anterior compartment, and this did not differ between the mesh and no mesh groups.
Patients included in the study were women with stage 2-4 prolapse who were randomized to the mesh or no mesh group at baseline. Three-month and 1-year outcomes were previously reported.
Although the study is underpowered because of the early halting of enrollment, and is limited by the substantial number of patients lost to follow-up, it also has several strengths, including the long-term follow-up, multicenter design, and robust definitions of cure.
Therefore, the findings of a similar cure rate in the mesh and no mesh groups, excellent quality of life improvements in both groups, a mesh exposure rate of 15.6%, and a finding of only one new mesh exposure between 1- and 3-year follow-up, suggest that a "balanced approach is really required for vaginal mesh repairs, including a thorough patient consent," Dr. Gutman concluded.
He reported having no relevant financial disclosures.