Adjunctive Immersive Virtual Reality for Urinary Incontinence-Related Quality of Life in Postmenopausal Women with Urinary Incontinence: A Non-Randomized Controlled Pilot Trial.

Background/Objectives: This study examined whether adding relaxation-oriented immersive virtual reality (VR) to pelvic floor muscle electrostimulation with electromyographic (EMG) biofeedback was associated with additional improvement in incontinence-related quality of life among postmenopausal women. Methods: In this exploratory non-randomized controlled pilot trial, 40 postmenopausal women received electrostimulation with EMG biofeedback alone (ES; n = 20) or the same intervention preceded by VR (VR + ES; n = 20). Participants completed eight sessions over 2 weeks and were assessed at baseline (T0), post-intervention (T1), and 2-week follow-up (T2); T1 was the prespecified primary assessment. The primary outcome was the Incontinence Quality of Life Questionnaire (I-QOL) total score. Secondary outcomes included pelvic floor EMG, bladder-diary variables, other quality-of-life measures, perceived stress, and self-esteem. Baseline-adjusted linear mixed models were used. The registry record was submitted before enrollment (NCT07070063). Results: Thirty-six participants contributed to the primary analysis. The adjusted between-group difference in I-QOL was -1.65 points at T1 (95% CI, -10.03 to 6.74; p = 0.70) and -4.00 points at T2 (95% CI, -12.38 to 4.39; p = 0.35). Adjusted contrasts were non-significant for the remaining questionnaire and EMG outcomes. Selected bladder-diary outcomes differed between groups, but these analyses were exploratory, unadjusted for multiple comparisons, and did not directly quantify urinary leakage. Conclusions: The study did not detect a statistically significant additional improvement in incontinence-related quality of life with adjunctive VR. Confidence intervals remained compatible with potentially meaningful effects in either direction. Given the small sample and non-randomized design, the findings are preliminary and hypothesis-generating.