Status:
TERMINATED
Botox as a Treatment for Chronic Male Pelvic Pain Syndrome
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Paul G. Allen Family Foundation
Conditions:
Chronic Male Pelvic Pain Syndrome
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
Chronic pelvic pain syndrome (CPPS) is thought to affect approximately 8% of men aged 18 and older. Patients with this condition experience pain in the perineum, the genitalia, and the rectum. As well...
Detailed Description
Visit 1 Patient will review and sign the study consent form. Subject will be asked to complete questionnaires. Then, patient will then be asked to give a semen sample. Visit 2 (1 week after Visit I) ...
Eligibility Criteria
Inclusion
- Men aged 18 and older
- History of chronic pelvic pain syndrome (NIH type IIIA and IIIB) for at least 3 months
- No antibiotics or new treatment for prostatitis for at least 30 days
- Written informed consent and written authorization for use or release of health and research study information have been obtained.
- Subject has severity/stage of disease: pain areas must include perineum.
- Laboratory findings required : negative urine cultures.
- Ability to follow study instructions and likely to complete all required visits.
Exclusion
- Documented urinary tract infection
- Bacteria isolated to the prostate from segmental urine cultures
- Pain from another source in the genitourinary tract (e.g. renal colic)
- Genitourinary (GU) malignancy
- History of radiation to the GU tract
- Previous or current botulinum therapy
- Known allergy or sensitivity to any study medication (Botox, lidocaine)
- Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, spinal cord injury or any other significant disease which might interfere with neuromuscular transmission
- Concurrent use of aminoglycoside antibiotics or agents that interfere with neuromuscular transmission
- Profound atrophy or excessive weakness of the muscles to be injected
- Infection at the injection site or systemic infection
- Concurrent participation in another investigational drug study
- Is overtly psychotic or suicidal.
- Has post-surgical pain
- Has back or rectal pain only.
- Was treated for prostate, bladder, renal or other genitourinary malignancy
- Had in the past or is currently undergoing radiation therapy
- Has a history of genitourinary tuberculosis
- Is currently taking antibiotics.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00194623
Start Date
August 1 2003
End Date
August 1 2007
Last Update
October 19 2007
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