To evaluate whether polyacrylamide hydrogel (PAHG) is non-inferior to tension-free vaginal tape (TVT) in treatment of women with primary stress urinary incontinence (SUI).
In this, controlled, non-inferiority clinical trial, primary SUI patients were randomized to TVT or PAHG treatments. The primary outcome was patient satisfaction, and secondary outcomes were effectiveness in reducing urinary leakage and complications at 1-year follow-up. For statistical power, the significance level was set at 5%, power at 80% and non-inferiority limit at 20%, with a 10% expected dropout rate.
Between September, 28, 2015 and March, 1, 2017, 224 women with primary SUI were randomized for TVT (n=111) or PAHG (n=113) treatment. At 1-year, a satisfaction score of ≥80 (VAS 0-100) was reached in 95.0 % of TVT and 59.8 % of PAHG patients, and thus, PAHG did not meet the non-inferiority criteria set in our study. In secondary outcomes, the cough stress test was negative in 95.0% of TVT patients versus 66.4% of PAHG patients (difference 28.6%, 95% CI 18.4%-38.5%), whereas most peri-operative complications (TVT n=23 versus PAHG n=3, difference 20.0%, 95 % CI 11.2%-29.2%) and all (n=6) re-operations (difference 5.9%, 95 % CI 1.2%-12.4%), due to complications were associated with TVT.
Midurethral TVT-slings show better satisfaction and cure rates than PAHG in primary SUI. However, complications were mainly associated with TVT. Thus, for women who expect to be completely cured by their initial treatment and are willing to accept the complication risks, TVT should be offered as the first line treatment. Since PAHG treatment also provides high satisfaction and cure rates, primary SUI women can be offered PAHG as an alternative treatment.
ClinicalTrials.gov, number NCT02538991.
The Journal of urology. 2019 Sep 03 [Epub ahead of print]
Anna-Maija Itkonen Freitas, Maarit Mentula, Päivi Rahkola-Soisalo, Sari Tulokas, Tomi S Mikkola
Helsinki University, Department of Obstetrics and Gynecology, Helsinki University Hospital., Helsinki University, Doctoral Programme in Clinical Research., Helsinki University, Department of Obstetrics and Gynecology, Helsinki University Hospital and Folkhälsan Research Center Biomedicum, Helsinki.