Efficacy of vaginal androgen combined with pelvic floor muscle training for stress urinary incontinence in postmenopausal women: a randomized-controlled trial.

OBJECTIVES

Postmenopausal women with stress urinary incontinence (SUI) exhibit low androgen expression. This study aimed to evaluate the efficacy and safety of vaginal androgen combined with pelvic floor muscle training (PFMT) in the treatment of SUI in postmenopausal women.

METHODS

Postmenopausal women with SUI were recruited from Hainan West Central Hospital between January 2024 and March 2025. Participants were randomly assigned in a double-blind manner to receive either vaginal androgen cream combined with PFMT (treatment group) or a visually identical placebo cream (without androgens) combined with PFMT (control group). The vaginal cream was applied to the vaginal wall at a dose of 0.5 g per application, twice weekly for a total of 10 applications, while PFMT was conducted for 8 weeks. The clinical efficacy and safety were compared between the two groups.

RESULTS

A total of 61 patients were finally enrolled, with 31 in the treatment group and 30 in the control group. At both 3-month and 6-month follow-ups, the treatment group demonstrated significantly lower values in daily pad usage (p < 0.05), 24-h pad test scores (p < 0.05), and ICIQ-UI SF scores (p < 0.05) compared to the control group. The improvement rate of urinary incontinence was significantly higher in the treatment group (p < 0.05). Compared to baseline, the treatment group showed statistically significant reductions in all three outcome measures (all p < 0.05). No severe adverse events were reported in either group during the treatment period.

CONCLUSIONS

Androgen therapy combined with PFMT significantly improved the urinary incontinence remission rate in postmenopausal women with SUI, with no severe adverse effects observed. These findings suggest that androgen therapy may represent a novel therapeutic approach for SUI management in postmenopausal women.

CLINICAL TRIAL REGISTRATION NUMBER: ChiCTR2300078752 in the Chinese Clinical Trial Registry.