A pilot study of botulinum toxin A for male chronic pelvic pain syndrome

Objective. Male chronic pelvic pain syndrome (CPPS) has been the subject of numerous clinical trials, but so far, no uniformly effective treatment has been identified. A commonly reported tender spot in men with CPPS is the bulbospongiosus muscle. A randomized placebo controlled pilot trial of botulinum toxin A (BTX-A) injection into the perineal skeletal musculature for the treatment CPPS was conducted. Material and methods. Twenty-nine men with CPPS were identified from a urology clinic. Symptom evaluation was performed using a Global Response Assessment (GRA) and the Chronic Prostatitis Symptom Index (CPSI). All subjects were randomized to receive either BTX-A 100 U or normal saline injected into the perineal body and bulbospongiosus muscle. Results. BTX-A injection was administered in 13 men. At the 1 month follow-up there was a 30% response rate for BTX-A treatment compared with 13% for placebo (p = 0.0002), based on GRA results. Total CPSI score did not reach significance in the BTX-A-treated group, compared with controls. The CPSI pain subdomain score reached statistical significance in the BTX-A patients compared with controls (p = 0.05). The injections were well tolerated. There were no complications from the injections and no patients reported side-effects. Conclusions. BTX-A injection into the perineal body and bulbospongiosus muscle results in a modest response rate on the GRA compared with placebo for overall symptoms associated with CPPS. The treatment is well tolerated and safe. BTX-A use may enhance polytherapeutic pain management.