Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Canada7 participantsStarted 2006-01
Plain-language summary
The objective of this study is to evaluate the safety and efficacy of intraprostatic injection of Botox for the treatment of men diagnosed with chronic nonbacterial prostatitis/chronic pelvic pain syndrome (CP/CPPS).
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Participant has signed and dated the appropriate Informed Consent document.
✓. Participant must be ≥ 18 years of age.
✓. Participant has had a clinical diagnosis of chronic nonbacterial prostatitis (chronic pelvic pain syndrome) (CPPS) defined as symptoms of discomfort or pain in the perineal or pelvic region for at least the past 3 months without evidence of bacterial infection.
✓. Participants must report ejaculatory pain and/or perineal discomfort.
✓. Participants must have pain or discomfort localized to perineum or prostate during physical examination.
✓. Participants must have an aggregate score of greater than or equal to 15 on the National Institutes of Health chronic prostatitis symptom index (NIH-CPSI).
✓. Participant must have \> 8 on the pain domain sub-score of the NIH-CPSI.
✓. Participant must have had empiric treatment with 4 weeks fluoroquinolone, and subsequently failed the antibiotic therapy.
Exclusion criteria
✕. Participant has a history of prostate, bladder or urethral cancer.
✕. Participant has inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).
✕. Participant has undergone pelvic radiation or systemic chemotherapy.
. Participant has undergone intravesical chemotherapy.
✕. Participant has been treated for unilateral orchialgia without pelvic symptoms.
✕. Participant has a current urethral stricture and/or bladder stones.
✕. Participant has a neurological disease or disorder affecting the bladder.
✕. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.