Presentation Authors: Anna-Maija Freitas, Maarit Mentula, Päivi Rahkola-Soisalo, Sari Tulokas, Tomi Mikkola*, Helsinki, Finland
Introduction: Retropubic tension-free vaginal tape (TVT) is the gold standard treatment for female stress urinary incontinence (SUI). Concerns have been raised about the complications associated with midurethral mesh slings, and medical authorities in several countries have published warnings and even suspended their use. Transurethral injection of polyacrylamide hydrogel (PAHG) is a safe, minimally invasive alternative. However, the efficacy of this treatment in primary SUI is undefined.We conducted a prospective, randomized, controlled, parallel-group, non-inferiority trial comparing TVT and PAHG.
Methods: A total of 224 women with primary SUI were randomized for TVT (n=111) or PAHG (n=113) treatment between September, 28, 2015, and March, 1, 2017. Primary outcomes were patient satisfaction, effectiveness and complications at 1-year follow-up. Data were analysed with an intention-to-treat basis. The trial has been registered with ClinicalTrials.gov, number NCT02538991.
Results: At 1-year follow-up the median (IQR 25-75 percentile) satisfaction score (0-100) for TVT was 99 and for PAHG 85 (p < 001) and thus, PAHG did not meet the non-inferiority criteria. Similarly as with objective cure rates, the cough stress test was negative in 95% of TVT patients versus 66% of PAHG patients (p < 001). However, most peri-operative complications (hematoma, bladder perforation or urinary retention) and all re-operations due to complications were associated with TVT. Furthermore, at 1-year erosions, pelvic /implantation site pain and difficulty to empty bladder were associated only with TVT.
Conclusions: Midurethral TVT-slings show better subjective and objective cure rates than PAHG in primary SUI. However, complications were mainly associated with TVT. Since the majority of PAHG treated women were also cured, primary SUI women can be offered PAHG as a safe first-line treatment, and subsequently TVT if unsuccessful. However, for women who expect to be completely cured by their initial treatment and are willing to accept the complication risks, TVT can be offered as the first line treatment.
Source of Funding: This study was funded by a Helsinki University Hospital research grant and an unrestricted grant from Contura. The funders of the study had no influence in the study design, data collection, data analysis, data interpretation, or writing of the report.