Tension-Free Vaginal Tape More Effective Than Polyacrylamide Hydrogel for Stress Urinary Incontinence: NEJM

Against the above background, Anna-Maija Itkonen Freitas, Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki, Finland, and colleagues conducted a randomized, controlled, noninferiority trial (with a margin of 20%) at Helsinki University Hospital, Finland, to compare the effectiveness of tension-free vaginal tape and PAHG treatment.

The study's primary outcome was patient satisfaction, with secondary outcomes focusing on treatment effectiveness and complications. While the results at 1 and 3 years have been previously published, this report presents the findings from the 5-year follow-up.

The key findings of the study were as follows:

• Of the 223 women initially randomized to a treatment group, 212 women received the assigned treatment, and 195 (92.0%) attended the 5-year follow-up.
• The median satisfaction score on the visual analog scale was 98 for the tension-free vaginal tape group and 90 for the PAHG group.
• A satisfaction score of 80 or higher was achieved by 92.7% of participants in the tension-free vaginal tape group, compared to 74.7% in the PAHG group, with a difference of 18.0 percentage points.
• PAHG did not meet the noninferiority criteria set in the trial.
• In the 5-year follow-up, peri- or postoperative complications occurred in 43.8% of women in the tension-free vaginal tape group and 22.2% of women in the PAHG group, with a difference of 21.5 percentage points.

"In the long-term follow-up, treatment for stress urinary incontinence with polyacrylamide hydrogel was found to be less effective than tension-free vaginal tape in terms of patient satisfaction scores," the researchers wrote. "Additionally, complications occurred twice as often in the TVT group compared to the PAHG group."

Reference: https://evidence.nejm.org/doi/full/10.1056/EVIDoa2400216