Botox as a Treatment for Chronic Male Pelvic Pain Syndrome
Status:
Terminated
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
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, 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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Washington
Collaborator:
Paul G. Allen Family Foundation
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA