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

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ClinicalTrials.gov Identifier: NCT00529386
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : September 14, 2011
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Centre for Advanced Urological Research, 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 Drug: Lidocaine Phase 2

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 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

Active Comparator: Lidocaine
1% Lidocaine
Drug: Lidocaine
1%




Primary Outcome Measures :
  1. GRA [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 12 Weeks ]
  2. NIH-CPSI [ Time Frame: 12 Weeks ]


Information from the National Library of Medicine

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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
Canada, Ontario
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

Responsible Party: Centre for Advanced Urological Research, Centre, Queen's University
ClinicalTrials.gov Identifier: NCT00529386     History of Changes
Other Study ID Numbers: BOTOX-CP
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: June 2009

Keywords provided by Centre for Advanced Urological Research, Queen's University:
prostatitis
Botox

Additional relevant MeSH terms:
Syndrome
Chronic Pain
Somatoform Disorders
Pelvic Pain
Prostatitis
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Prostatic Diseases
Genital Diseases, Male
Lidocaine
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Acetylcholine Release Inhibitors