Chronic Male Pelvic Pain Syndrome Clinical Trial
Official title:
Botox (Botulinum Toxin A) as a Treatment for Chronic Male Pelvic Pain Syndrome: A Randomized Placebo Controlled Trial
Verified date | October 2007 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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, there is associated voiding, sexual, and ejaculatory dysfunction. The
impact of patient well-being is thought to be equivalent to patients with congestive heart
failure. The etiology of this condition is unknown, thus making treatment very difficult.
Researchers have pursued an infectious cause for the disease; however, studies have failed
to substantiate this theory. Despite this, the main treatment offered to patients is
long-term antibiotic therapy. Results from this treatment modality have been unsatisfactory.
Other groups have postulated that the symptoms of CPPS may be secondary to neuromuscular
factors. Some studies have demonstrated increases in pelvic muscular tone. Maneuvers such as
prostate massage and levator massage have shown some benefit in relieving symptoms.
Treatment with alpha-blockers to relax prostate smooth muscle has brought about improvement
in a portion of patients. Use of generalized muscle relaxants has produced mediocre results.
However, many of these neuromuscular treatments are generalized and do not target the
perineal musculature directly. It is theorized that spasm of the perineal muscles triggered
by an unknown noxious stimuli (e.g. infection) cause the pain and symptoms of CPPS. At our
center, we have performed pilot studies using botulinum toxin A. Four patients were treated
with Botox". 100 U were injected in three locations in the midline of the bulbocavernosus
muscle. The bulbocavernosus muscle is easily accessible and shares innervation with the
pelvic musculature. Patient's response to medication was measured by the NIH Prostatitis
pain scale and as well as the University of Washington prostatitis pain scale. All patients
reported resolution of symptoms. Remission lasted for duration of 10-12 weeks. No patients
reported adverse events.
HYPOTHESIS
Botulinum toxin A is effective in the treatment of chronic pelvic pain syndrome in men.
Status | Terminated |
Enrollment | 30 |
Est. completion date | August 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Paul G. Allen Family Foundation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NIH-CPSI -pain scores at 3 months post-treatment follow-up | 3 months post treatment | ||
Secondary | AUA score at 3 months post-treatment follow-up | 3 months post-treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT00194636 -
Effectiveness of Sympathetic Plexus Block on Male Pelvic Pain (Prostatitis, Prostatodynia)
|
Phase 4 |