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

• Sponsor: Queen's University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00529386
• Collaborator: Allergan (Industry)
• Enrollment: 7
• Location: 1
• Arm: 1
• Duration (Months): 47
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Prostatitis; Chronic Pain Syndrome	Drug: Botox	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botox 300 IU botox	Drug: Botox; 300 units; Other Names: Botulinem toxin

Outcome Measures

Primary Outcome Measures

1. GRA [12 weeks]

   At 12 weeks there were no GRA responders. Study stopped because of futility.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Advanced Urological Research	Kingston	Ontario	Canada	K7L 3J7

Sponsors and Collaborators

• Queen's University
• Allergan

Investigators

• Principal Investigator: J. Curtis Nickel, MD FRCSC, Queen's University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. J. Curtis Nickel, Principal Investigator, Queen's University
• ClinicalTrials.gov Identifier: NCT00529386
• Other Study ID Numbers: BOTOX-CP
• First Posted: Sep 14, 2007
• Last Update Posted: Mar 25, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Dr. J. Curtis Nickel, Principal Investigator, Queen's University: prostatitis; Botox
• Additional relevant MeSH terms: Prostatitis; Syndrome; Chronic Pain; Pelvic Pain; Somatoform Disorders

Study Results

Participant Flow

Arm/Group Title	Botox
Arm/Group Description	300 IU botox Botox: 300 units
Period Title: Overall Study
STARTED	7
COMPLETED	6
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Botox
Arm/Group Description	300 IU botox Botox: 300 units
Overall Participants	7
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	7 100%
Region of Enrollment (participants) [Number]
Canada	7 100%

Outcome Measures

1. Primary Outcome

Title	GRA
Description	At 12 weeks there were no GRA responders. Study stopped because of futility.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

7 CPCPPS patients enrolled and analysed before stopping study because of futility

Arm/Group Title	Botox
Arm/Group Description	300 IU botox Botox: 300 units
Measure Participants	7
Count of Participants [Participants]	0 0%

Adverse Events

Arm/Group Title	Botox
Arm/Group Description	300 IU botox Botox: 300 units
All Cause Mortality
	Botox
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Botox
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	Botox
	Affected / at Risk (%)	# Events
Total	0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.