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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00194623 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Botox as a Treatment for Chronic Male Pelvic Pain Syndrome
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Scientific title:
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Botox (Botulinum Toxin A) as a Treatment for Chronic Male Pelvic Pain Syndrome: A Randomized Placebo Controlled Trial |
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Date of first enrolment:
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August 2003 |
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Target sample size:
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30 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00194623 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Richard E Berger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor of Urology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Chronic Male Pelvic Pain Syndrome
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Intervention(s)
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Drug: Botulinum Toxin A (Botox)
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Primary Outcome(s)
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NIH-CPSI -pain scores at 3 months post-treatment follow-up
[Time Frame: 3 months post treatment]
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Secondary Outcome(s)
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AUA score at 3 months post-treatment follow-up
[Time Frame: 3 months post-treatment]
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Secondary ID(s)
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02-5458-A 04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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