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.
RCT Entities:
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.