Introduction and hypothesis: Most patients suffering from vaginismus feel sinful, anxious, and incompetent, with reduced self-confidence. This study was aimed at comparing the effectiveness of the physiotherapy of pelvic floor muscles as a standard treatment and local injection of botulinum toxin on the sexual functioning of patients with primary vaginismus.
Methods: In this randomized clinical trial (RCT), the study population included women with primary vaginismus referred to the Sexual Health and Gynecologic Clinics of Imam Khomeini Hospital during 2013-2014. They were diagnosed according to DSM-5 criteria and underwent treatments with botulinum injection (intervention group) and physiotherapy as the current treatment (control group). The participants' primary and secondary outcomes were measured based on successful intercourse and sexual functioning of each group.
Results: The results indicated that the overall standard physiotherapy, along with other measurements, such as functional electrical stimulation and desensitization, could effectively improve the patients' Female Sexual Function Index compared with botulinum treatment. At the end of the study, it was found that 20 and 26 patients out of the 30 and 28 patients in the intervention and control groups managed to have successful intercourse respectively (P = 0.014). Also, sexual dysfunction frequencies were seen to be decreased by 26.6% and 50% in the mentioned groups respectively (p = 0.008 and p < 0.001).
Conclusions: Considering the higher efficacy of physiotherapy procedures compared with those of the desensitization and electrical stimulation techniques, this therapeutic method should be considered the first-line treatment of vaginismus (IRCT2016061828486N1).
Keywords: Botulinum toxin; Functional electrical stimulation; Lifelong vaginismus; Physiotherapy; Sexual function.