Efficacy and Safety of Polyacrylamide Hydrogel for Stress Urinary Incontinence: A Retrospective Longitudinal US Study...

Polyacrylamide hydrogel (PAHG) is a urethral bulking agent for stress urinary incontinence (SUI) that received FDA approval in 2020. In mixed urinary incontinence (MUI), PAHG may be used concomitantly with onabotulinumtoxinA to address both urinary stress and urgency components. We sought to evaluate symptom outcomes and safety after PAHG treatment for SUI and to assess outcomes after concomitant onabotulinumtoxinA.

We retrospectively reviewed women treated with PAHG for SUI as an outpatient procedure at a single institution between December 2021 and September 2025. Outcomes were compared between baseline and postoperative follow-up intervals of ≤12, 12-24, and 24-45 months. Primary outcomes were changes in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and SUI visual analog scale (VAS). Statistical analyses were conducted with p < 0.05 considered significant.

Among 173 women, ICIQ-SF and SUI-VAS scores significantly improved from baseline across all follow-up intervals (p < 0.001). Pad use decreased at follow-up, and nocturia improved at the first and second follow-up intervals. In the overall cohort, urinary frequency and cough-test positivity numerically improved but did not reach statistical significance. Patients treated with concomitant onabotulinumtoxinA also improved from baseline; however, repeated-measures analysis of variance (ANOVA) did not demonstrate a significant between-group difference compared with PAHG alone.

In this study, PAHG was associated with clinically meaningful improvement in SUI symptoms and few complications. Concomitant onabotulinumtoxinA appeared feasible in selected patients with MUI, although superiority over PAHG alone was not demonstrated. Extended follow-up findings should be interpreted cautiously because of attrition at later time points.