Trial reportInternational journal of women's health2026
Combined Sensate Focus and Pelvic Floor Muscle Training versus Pelvic Floor Muscle Training Alone for Sexual Function in Women with Stress Urinary Incontinence: A Randomized Controlled Trial.
Trial report in International journal of women's health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Stress urinary incontinence (SUI) is the most common subtype of urinary incontinence among women, with reported prevalence ranging from approximately 15% to 35% depending on population and diagnostic criteria, and it impairs sexual function through physiological and psychological mechanisms. Pelvic floor muscle training (PFMT) addresses anatomical deficits but not psychosocial barriers such as intimacy avoidance and performance anxiety. Sensate focus, a psychobehavioral technique, reduces performance demand and reconnects couples with pleasurable bodily sensations. This trial evaluated whether combining sensate focus with PFMT yields superior improvement in sexual function versus PFMT alone in married women with SUI. Methods: In this parallel-group, superiority randomized controlled trial across private gynecology clinics in Tehran and Qom, Iran, 60 married women (18-49 years) with clinically confirmed SUI were randomized 1:1 to combined sensate focus plus PFMT (n=30) or PFMT alone (n=30). Primary outcome was FSFI score change at baseline, 1, and 2 months; secondary outcome was pelvic floor muscle (PFM) strength (Modified Oxford Grading Scale). Outcome assessment was not blinded. Results: Total FSFI score rose from 16.97±4.21 to 30.68±0.54 with combined treatment but fell from 20.74±4.74 to 16.53±3.20 with PFMT alone (mean change from baseline +13.7 vs -4.2 points), an adjusted between-group difference in change of 17.8 points (95% CI 16.2-19.5; p<0.001), exceeding the minimum clinically important difference (8-10 points). PFM strength improved more with combined treatment, adjusted difference 1.21 grades (95% CI 0.97-1.46; p<0.001). Conclusion: In this single-center trial of 60 women followed for two months, combining sensate focus with PFMT was associated with clinically meaningful improvement in sexual function and PFM strength beyond PFMT alone. Given the limited sample size, single-center design, and short follow-up, this combined approach appears a promising adjunct to standard urogynecological care, pending confirmation in larger, multicenter trials with longer follow-up. Trial Registration: IRCT20240821062824N1 (Registered at the Iranian Registry of Clinical Trials on 2025-02-24).
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