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 range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.