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

Primary Purpose

Prostatitis, Chronic Pain Syndrome

Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Botox
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatitis focused on measuring prostatitis, Botox

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Centre for Advanced Urological Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Botox

Arm Description

300 IU botox

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 12, 2007
Last Updated
March 21, 2019
Sponsor
Queen's University
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00529386
Brief Title
Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
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 Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Allergan

4. Oversight

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
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatitis, Chronic Pain Syndrome
Keywords
prostatitis, Botox

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox
Arm Type
Experimental
Arm Description
300 IU botox
Intervention Type
Drug
Intervention Name(s)
Botox
Other Intervention Name(s)
Botulinem toxin
Intervention Description
300 units
Primary Outcome Measure Information:
Title
GRA
Description
At 12 weeks there were no GRA responders. Study stopped because of futility.
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant has signed and dated the appropriate Informed Consent document. Participant must be ≥ 18 years of age. 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. Participants must report ejaculatory pain and/or perineal discomfort. Participants must have pain or discomfort localized to perineum or prostate during physical examination. 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). Participant must have > 8 on the pain domain sub-score of the NIH-CPSI. Participant must have had empiric treatment with 4 weeks fluoroquinolone, and subsequently failed the antibiotic therapy. Exclusion Criteria: Participant has a history of prostate, bladder or urethral cancer. Participant has inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome). Participant has undergone pelvic radiation or systemic chemotherapy. Participant has undergone intravesical chemotherapy. Participant has been treated for unilateral orchialgia without pelvic symptoms. Participant has a current urethral stricture and/or bladder stones. Participant has a neurological disease or disorder affecting the bladder. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol. Participant has a documented UTI within the last 3 months. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2). Participant has had previous intraprostatic injection of Botox. Participant currently enrolled in an investigational study. Participant interested in future fertility/fathering children. Participant with urinary retention (PVR >200cc). Participant having had prostate surgery in the past 3 months. Participant having had minimally invasive surgical therapy for BPH. Participant with a cystostomy or nephrostomy. Participant with penile or urinary sphincter implants. Participant with previous rectal surgery, current rectal disease or peri-rectal inflammatory disorders except hemorrhoidectomy. Participant with PSA >10 ng/ml(PSA range 4-10, biopsy at PI discretion (deferral).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Curtis Nickel, MD FRCSC
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Advanced Urological Research
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada

12. IPD Sharing Statement

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

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