NEJM evidence · 2025
Tension-Free Vaginal Tape versus Polyacrylamide Hydrogel Injection for Stress Urinary Incontinence - 5-Year Follow-Up.
СтатьяРандомизированное исследованиеСравнительное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Freitas Anna-Maija Itkonen, Isaksson Camilla, Rahkola-Soisalo Päivi, Mentula Maarit, Mikkola Tomi S
Аннотация
BACKGROUND: Tension-free vaginal tape has been the gold standard of treatment for female stress urinary incontinence, but concerns have risen about the safety of mesh. Transurethral injection of polyacrylamide hydrogel (PAHG) is a minimally invasive alternative. However, the long-term safety, efficacy, and patient satisfaction of PAHG is undefined.
METHODS: We conducted a randomized, controlled, noninferiority (margin 20%) trial at Helsinki University Hospital, Finland, comparing tension-free vaginal tape with PAHG treatment. The primary outcome was patient satisfaction. Secondary outcomes were effectiveness and complications. The results at 1 and 3 years have been previously reported. Herein, we report the 5-year follow-up.
RESULTS: Of the 223 women originally randomly assigned to a treatment group, 212 women underwent treatment as randomly assigned and, at 5 years, 195 (92.0%) women attended the follow-up. The median satisfaction score (visual analog scale: range, 0 to 100; higher scores indicated higher satisfaction) was 98 (interquartile range, 86 to 100) in the tension-free vaginal tape group, and 90 (interquartile range, 75 to 99) in the PAHG group, whereas a score of 80 or more was reached in 89 (92.7%) and 74 (74.7%) participants (difference, 18.0 percentage points; 95% confidence interval [CI], 7.7 to 28.0), respectively. Thus, PAHG did not meet the noninferiority criteria set in our trial. Within the 5-year follow-up, a peri- or postoperative complication before crossover between the groups was detected in 42 (43.8%) women in the tension-free vaginal tape group and 22 (22.2%) women in the PAHG group (difference, 21.5 percentage points; 95% CI, 8.4 to 33.8).
CONCLUSIONS: In long-term follow-up, treatment of stress urinary incontinence with PAHG was not noninferior to treatment with tension-free vaginal tape with respect to patient satisfaction scores. Complications were twice as common in the tension-free vaginal tape group. (Funded by Helsinki University Hospital and Contura; ClinicalTrials.gov number, NCT02538991.).
METHODS: We conducted a randomized, controlled, noninferiority (margin 20%) trial at Helsinki University Hospital, Finland, comparing tension-free vaginal tape with PAHG treatment. The primary outcome was patient satisfaction. Secondary outcomes were effectiveness and complications. The results at 1 and 3 years have been previously reported. Herein, we report the 5-year follow-up.
RESULTS: Of the 223 women originally randomly assigned to a treatment group, 212 women underwent treatment as randomly assigned and, at 5 years, 195 (92.0%) women attended the follow-up. The median satisfaction score (visual analog scale: range, 0 to 100; higher scores indicated higher satisfaction) was 98 (interquartile range, 86 to 100) in the tension-free vaginal tape group, and 90 (interquartile range, 75 to 99) in the PAHG group, whereas a score of 80 or more was reached in 89 (92.7%) and 74 (74.7%) participants (difference, 18.0 percentage points; 95% confidence interval [CI], 7.7 to 28.0), respectively. Thus, PAHG did not meet the noninferiority criteria set in our trial. Within the 5-year follow-up, a peri- or postoperative complication before crossover between the groups was detected in 42 (43.8%) women in the tension-free vaginal tape group and 22 (22.2%) women in the PAHG group (difference, 21.5 percentage points; 95% CI, 8.4 to 33.8).
CONCLUSIONS: In long-term follow-up, treatment of stress urinary incontinence with PAHG was not noninferior to treatment with tension-free vaginal tape with respect to patient satisfaction scores. Complications were twice as common in the tension-free vaginal tape group. (Funded by Helsinki University Hospital and Contura; ClinicalTrials.gov number, NCT02538991.).