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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00529386
Recruitment Status : Terminated
First Posted : September 14, 2007
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Dr. J. Curtis Nickel, Queen's University

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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 : January 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Pelvic Pain

Arm Intervention/treatment
Experimental: Botox
300 IU botox
Drug: Botox
300 units
Other Name: Botulinem toxin




Primary Outcome Measures :
  1. GRA [ Time Frame: 12 weeks ]
    At 12 weeks there were no GRA responders. Study stopped because of futility.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529386


Locations
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Canada, Ontario
Centre for Advanced Urological Research
Kingston, Ontario, Canada, K7L 3J7
Sponsors and Collaborators
Queen's University
Allergan
Investigators
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Principal Investigator: J. Curtis Nickel, MD FRCSC Queen's University

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Responsible Party: Dr. J. Curtis Nickel, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00529386     History of Changes
Other Study ID Numbers: BOTOX-CP
First Posted: September 14, 2007    Key Record Dates
Results First Posted: March 11, 2019
Last Update Posted: March 11, 2019
Last Verified: November 2018

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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, Queen's University:
prostatitis
Botox

Additional relevant MeSH terms:
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Syndrome
Chronic Pain
Somatoform Disorders
Pelvic Pain
Prostatitis
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Prostatic Diseases
Genital Diseases, Male
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents