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

Chronic Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00529386
• Other study ID #: BOTOX-CP
• Status: Terminated
• Phase: Phase 1
• Start date: January 2006
• Est. completion date: December 2009

Study information

• Verified date: March 2019
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

This is a prospective open label study examining the efficacy and safety of intraprostatic Botox . Men with a clinical diagnosis of chronic nonbacterial prostatitis/CPPS will be treated with intraprostatic Botox™ and followed for 12 weeks (primary efficacy analyses), and 24 weeks (long term follow-up) for responders.

It is proposed that 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).

Outcome measures include Chronic Prostatitis Symptom Index (CPSI 0-35), NRS pain (0-10), Global Response Assessment (GRA) at 12 weeks. Safety to be monitored during the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• Botox
300 units

Locations

Country	Name	City	State
Canada	Centre for Advanced Urological Research	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GRA	At 12 weeks there were no GRA responders. Study stopped because of futility.	12 weeks