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

Condition(s) targeted: Prostatitis; Chronic Pelvic Pain Syndrome

Intervention: Botox (Drug); Lidocaine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Queen's University

Official(s) and/or principal investigator(s):
J. Curtis Nickel, MD FRCSC, Principal Investigator, Affiliation: Queen's University

Overall contact:
J. Curtis Nickel, MD FRCSC, Phone: (613) 548-2497, Email: jcn@post.queensu.ca

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).

Official title: A Prospective Pilot Randomized Sham Controlled Study to Evaluate the Safety and Efficacy of Botox™ for the Treatment of Men Diagnosed With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: GRA

Secondary outcome:

Safety

NIH-CPSI

Detailed description: This is a blinded prospective randomized design comparing the efficacy and safety of intraprostatic Botox vs. intraprostatic lidocaine injection, with an optional open label extension. Men with a clinical diagnosis of chronic nonbacterial prostatitis/CPPS will be treated with intraprostatic Botox™ or 1% lidocaine and followed for 12 weeks (primary efficacy analyses), and 24 weeks (long term follow-up) for responders. An open label extension will be offered to non-responders.

A total of 40 males will be enrolled. There will be seven (7) research clinic visits and two phone contacts: Visit 1 (screening), Visit 2 (baseline/treatment), Visit 3 (2-week safety

evaluation - clinic contact), Visit 4 (4-week safety evaluation - phone contact), Visit 5

(6-week interim efficacy/safety), Visit 6 (12-week primary endpoint evaluation), Visit 7 (14-week clinic follow up), Visit 8 (16 week phone contact) and Visit 9 (24-week clinic close out).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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).

J. Curtis Nickel, MD FRCSC, Phone: (613) 548-2497, Email: jcn@post.queensu.ca

Centre for Advanced Urological Research, Kingston, Ontario K7L 3J7, Canada; Recruiting
Joseph Downey, MSc CCRP, Phone: (613) 548-7832, Email: downeyj@post.queensu.ca
J. Curtis Nickel, MD FRCSC, Principal Investigator
Alvaro Morales, MD FRCSC, Sub-Investigator

Starting date: January 2006
Ending date: September 2009
Last updated: November 5, 2008