Can Low Dose Tadalafil Improve the Sexual Functions in Women with Genital Mutilation?
Abstract
Introduction and hypothesis: Female genital mutilation (FGM) is associated with female sexual dysfunction (FSD) through anatomical disruption and impaired genital vascular function. Phosphodiesterase-5 inhibition may enhance genital perfusion via nitric oxide-mediated pathways. We hypothesized that tadalafil improves sexual function and clitoral vascular parameters in women with FGM-related FSD.
Methods: In this randomized, single-blind, placebo-controlled trial, 66 women with FGM-related FSD were randomized; 52 completed follow-up and were included in a modified intention-to-treat analysis (tadalafil 5 mg once daily, n = 25; placebo, n = 27) for 8 weeks. Sexual function was assessed using the Female Sexual Function Index (FSFI). Their FGM type was classified on the basis of WHO criteria. Clitoral color Doppler ultrasonography measured peak systolic velocity (PSV), resistance index (RI), and pulsatility index (PI). The primary endpoint was the between-group difference in change in total FSFI score from baseline to 8 weeks.
Results: Baseline characteristics were comparable between groups. Tadalafil significantly improved total FSFI score compared with placebo (mean change +5.47 vs -0.41; p < 0.001). Improvements were observed across all FSFI domains except lubrication. Significant increases in clitoral PSV, RI, and PI were detected in the tadalafil group, whereas no significant changes occurred in the placebo group. Greater benefit was observed in women with type I FGM.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 66 participants or records.
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