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JU INSIGHT Tension-Free Vaginal Tape and Polyacrylamide Hydrogel Injection for Primary Stress Urinary Incontinence: 3-Year Followup from a Randomized Clinical Trial
By: Anna-Maija Itkonen Freitas, MD; Camilla Isaksson, MD; Paivi Rahkola-Soisalo, MD; Sari Tulokas, MD; Maarit Mentula, MD; Tomi S. Mikkola, MD | Posted on: 01 Sep 2022
Freitas A-MI, Isaksson C, Rahkola-Soisalo P et al. Tension-free vaginal tape and polyacrylamide hydrogel injection for primary stress urinary incontinence: 3-year followup from a randomized clinical trial. J Urol. 208(3)658-667.
Study Need and Importance
Retropubic tension-free vaginal tape (TVT) has been the gold standard treatment for female stress urinary incontinence (SUI). Concerns have been raised about the long-term complications associated with mid urethral mesh slings, and medical authorities in some countries have published warnings and even suspended their use. Transurethral injection of polyacrylamide hydrogel (PAHG) is a minimally invasive alternative; however, the long-term patient satisfaction, safety and efficacy of this treatment in primary SUI are undefined.
What We Found
In this randomized noninferiority trial with 223 randomized patients at 3-year followup the satisfaction score (visual analogue scale 0–100) median was 98.5 in the TVT group and 90.0 in the PAHG group, whereas a score ≥80 was reached in 95% and 68%, respectively (see Figure). Thus, PAHG did not meet the noninferiority criteria set in our study. Within the 3-year followup period, any peri- or postoperative complication before crossover between the groups was detected in 44% of women in the TVT group and 24% of women in the PAHG group.
Limitations
According to our normal clinical practice, we did not perform invasive urodynamics in all women after detailed office evaluation for SUI. Although our data cannot be fully generalized to other mid urethral slings or bulking agents, we studied TVT, which is the gold standard for SUI, and PAHG, being currently the most commonly used bulking agent in Europe.
Interpretations for Patient Care
In midterm followup, PAHG did not reach in patient satisfaction the noninferiority set in our study. However, since most PAHG-treated women considered themselves cured or improved and the vast majority of women were satisfied without the need for further invasive treatment, PAHG can be offered as a safe and durable alternative treatment for women with SUI.