Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) - Full Text View

Sponsor:	Queen's University
Collaborator:	Allergan
Information provided by (Responsible Party):	Centre for Advanced Urological Research, Queen's University
ClinicalTrials.gov Identifier:	NCT00529386

Purpose

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	Intervention	Phase
Prostatitis Chronic Pain Syndrome	Drug: Botox Drug: Lidocaine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Botox Pelvic Pain

Drug Information available for: Botulinum toxin A Lidocaine

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:

GRA [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
NIH-CPSI [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	January 2006
Study Completion Date:	December 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Botox 300 IU botox	Drug: Botox 300 units
Active Comparator: Lidocaine 1% Lidocaine	Drug: Lidocaine 1%

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Centre for Advanced Urological Research, Centre, Queen's University
ClinicalTrials.gov Identifier:	NCT00529386 History of Changes
Other Study ID Numbers:	BOTOX-CP
Study First Received:	September 12, 2007
Last Updated:	September 13, 2011
Health Authority:	Canada: Health Canada

Keywords provided by Queen's University:

prostatitis
Botox

Additional relevant MeSH terms:

Pelvic Pain
Prostatitis
Chronic Disease
Somatoform Disorders
Pain
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease Attributes
Pathologic Processes
Mental Disorders
Botulinum Toxins, Type A
Lidocaine

Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012