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Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

TerminatedPhase 1NCT00529386
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

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).

Study details

Official title
A Prospective Pilot Study to Evaluate the Safety and Efficacy of Botox™ for the Treatment of Men Diagnosed With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Interventions
Sponsor
Queen's University
Collaborators
Allergan
Start date
2006-01
Primary completion
2009-09
Sex
Male
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Canada
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Participant has signed and dated the appropriate Informed Consent document. 2. Participant must be ≥ 18 years of age. 3. 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. 4. Participants must report ejaculatory pain and/or perineal discomfort. 5. Participants must have pain or discomfort localized to perineum or prostate during physical examination. 6. 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). 7. Participant must have \> 8 on the pain domain sub-score of the NIH-CPSI. 8. Participant must have had empiric treatment with 4 weeks fluoroquinolone, and subsequently failed the antibiotic therapy. Exclusion Criteria: 1. Participant has a history of prostate, bladder or urethral cancer. 2. Participant has inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome). 3. Participant has undergone pelvic radiation or systemic chemotherapy. 4. Participant has undergone intravesical chemotherapy. 5. Participant has been treated for unilateral orchialgia without pelvic symptoms. 6. Participant has a current urethral stricture and/or bladder stones. 7. Participant has a neurological disease or disorder affecting the bladder. 8. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol. 9. Participant has a documented UTI within the last 3 months. 10. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2). 11. Participant has had previous intraprostatic injection of Botox. 12. Participant currently enrolled in an investigational study. 13. Participant interested in future fertility/fathering children. 14. Participant with urinary retention (PVR \>200cc). 15. Participant having had prostate surgery in the past 3 months. 16. Participant having had minimally invasive surgical therapy for BPH. 17. Participant with a cystostomy or nephrostomy. 18. Participant with penile or urinary sphincter implants. 19. Participant with previous rectal surgery, current rectal disease or peri-rectal inflammatory disorders except hemorrhoidecto…

Canadian sites (1)

FacilityCityProvince
Centre for Advanced Urological ResearchKingstonOntario

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00529386