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

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen's University
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; Lidocaine; onabotulinumtoxinA

Criteria

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 hemorrhoidectomy.

20. Participant with PSA >10 ng/ml(PSA range 4-10, biopsy at PI discretion (deferral).