Effect of bulbospongiosus muscle injection with botulinum-A toxin for treatment of primary premature ejaculation. A preliminary results of randomized controlled trial

Background: Premature ejaculation is a common sexual disorder that significantly impacts the quality of life for both men and their partners. Various treatment options have been explored, including behavioral techniques, selective serotonin reuptake inhibitors (SSRIs), and local anesthetics. However, the outcomes of these treatments have been inconsistent for many patients. This study aimed to evaluate the effectiveness and safety of injecting botulinum-A toxin into the bulbospongiosus muscle for treating premature ejaculation (PPE) in Egyptian patients. Materials and methods: Sixty patients with PPE were randomly assigned prospectively to two groups: one receiving botulinum-A toxin injections and the other receiving saline injections as a placebo. The injection was done under US guidance to localize the site of bulbospongiosus muscle. Results: After the follow-up period, 57 patients completed the study. Initially, there were no significant differences between the two groups in terms of age, baseline Intravaginal Ejaculation Latency Time (IELT), Premature Ejaculation Profile (PEP) score, or partner satisfaction. Throughout the study, there were no statistically significant differences between the two groups in terms of IELT, PEP score, or female partner satisfaction at 1, 3, and 6 months after the intervention. However, the treatment group did show a significant increase in the median PEP score at 1 and 3 months compared to baseline. Unfortunately, no significant change was observed at 6 months, and there was no improvement in IELT or female partner satisfaction at any of the time points. Conclusion: While the treatment was found to be safe, this study did not demonstrate significant efficacy of botulinum-A toxin injections into the bulbospongiosus muscle for managing PPE symptoms when compared to a placebo. Further research with larger sample sizes is needed to validate these findings and explore alternative treatment options for PPE.