Background: Female sexual dysfunction (FSD) is a prevalent and multifaceted condition affecting women's sexual well-being. This randomized controlled trial aimed to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS) compared to a validated sham control in the treatment of FSD.
Methods: We conducted a single-center randomized controlled trial. Participants with FSD were recruited and randomly assigned at a 1:1 allocation ratio to either PTNS or a validated sham control using transcutaneous nerve stimulation (TENS). Treatment was performed through weekly 30-min session for 12 weeks total. Sexual function was assessed at baseline, 6 weeks, and 12 weeks primarily using the Female Sexual Function Index (FSFI) questionnaire. Urogenital distress inventory-6 was collected to evaluate for any baseline urinary incontinence/voiding dysfunction. Linear mixed-effect models for longitudinal data were used to compare FSFI scores across different time points. Statistical analysis was performed using SAS 9.4 (SAS Institute Inc. Cary, NC).
Results: In total, 34 PTNS and 31 TENS subjects were included in our final analysis. Overall, 48% (16/34) of PTNS subjects versus 29% (11/33) of TENS subjects were no longer at risk for FSD (FSFI > 26.55) after 12 weekly treatments. Both PTNS and TENS subjects demonstrated similar improvements in FSFI total scores after 12 weeks of treatments. Interestingly, patients who did not present with baseline urogenital distress symptoms reported a statistically significant larger improvement in sexual satisfaction after PTNS treatments as compared to placebo (p = 0.017).
Conclusion: This study demonstrated a sustained efficacy of PTNS in improving sexual function. Specifically, patients who did not have coexisting urinary dysfunction reported significant improvement in sexual satisfaction after PTNS. Our study suggested that PTNS may have a direct neuromodulation effect on sexual dysfunction and may hold promise as a treatment modality for FSD.
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