The Effectiveness of Therapeutic Interventions on Sexual Function in Women with Vaginismus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Objectives: Vaginismus is a complex sexual pain disorder that severely impairs sexual function and quality of life. Evidence regarding the effectiveness of therapeutic interventions remains fragmented and inconsistent. This systematic review and meta-analysis aimed to evaluate the effects of therapeutic interventions applied to women diagnosed with vaginismus on penetration-related outcomes and multidimensional sexual function, as assessed by validated outcome measures. Methods: The meta-analysis research and study selection were conducted independently by two researchers. The final literature search was completed on July 28, 2025. Studies published between January 2013 and July 2025 were searched in PubMed, Scopus, Web of Science, Cochrane Library, PsycINFO, and TR Dizin databases. Study quality was assessed using the GRADE approach, and risk of bias was evaluated using the Risk of Bias tool. Data synthesis and analyses were performed using Review Manager software. Results: Fifteen RCTs (n = 950; 494 intervention, 456 control) were included. Therapeutic interventions significantly improved overall sexual function in women with vaginismus (FSFI total score(SMD = 0.94; 95% CI:0.37-1.51, p = 0.001; I-2=93%) and penetration success (SMD = 0.61; 95% CI:0.38-0.84, p < 0.00001; I-2=43%). Mindfulness/ACT (SMD = 0.33; 95% CI: 0.07-0.60; I-2=0%) and technology-based interventions (SMD = 0.49; 95% CI:0.15-0.83; I-2 = 0%) showed consistent, moderate effects. Pelvic floor-based approaches had the largest effect (SMD = 4.49; 95% CI: 0.10-8.87; I-2=98%). FSFI subdomains improved significantly, except orgasm. Independent pain outcomes were non-significant (SMD = 0.02; 95% CI:-1.12 to 1.16, p = 0.97; I-2=91%), while combined psychological outcomes showed small improvements (SMD=-0.35; 95% CI:-0.64 to -0.05, p = 0.02; I-2=48%). Conclusion: Therapeutic interventions for vaginismus are associated with meaningful improvements in penetration-related outcomes and multiple dimensions of sexual function, without implying complete resolution of the condition. Mindfulness/ACT-based and technology-assisted approaches appear to offer the most consistent benefits. These findings highlight the importance of integrating evidence-based, multidisciplinary strategies into clinical practice and underscore the need for well-designed, standardized randomized controlled trials to optimize treatment outcomes.