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
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.
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) Prior to this visit, the patient will be randomized to either
active medication or placebo. First, the patient will then undergo a physical exam including
a genital and rectal exam. Then, the patient will be brought in to the room and placed in
lithotomy position. The perineum will be prepped with iodine solution. EMG electrodes and a
ground will be placed in the perineum. Three landmarks (1. middle of bulbospongiosus muscle;
2. perineal body; 3. an area equidistant from 1 and 2) will be marked using a skin marker.
The EMG needle will be placed into each landmark and the patient will be asked to squeeze
his perineal muscles. Once in the proper location, 1.3 cc of medication (active drug or
placebo) will be distributed into these landmarks. The remaining 2.6 ccs will be injected
into 2 other painful pelvic muscle sites as determined physical exam. The area will then be
gently massaged.
1. Month Post Injection Mailing:
The patient will be mailed a packet containing follow-up questionnaires.
2. Month Post Injection Mailing: Same as 1 Month Post Injection Visit.
3. Month Post Visit (Visit 3) First, the subject will be asked to fill out follow-up
questionnaires. Next, a physical exam and prostate massage will be performed and
expressed prostatic secretions collected. Finally, the subject will be asked to provide
a semen sample.
Optional open label trial for those patients randomized to placebo section:
Open label injection visit (Visit 4) Injection of open label Botox as in Visit 2.
1. Month Post Open Label Botox Injection Mailing:
The patient will be mailed a packet containing follow-up questionnaires.
2. Month Post Open Label Botox Injection Mailing:
Same as 1 Month Post Injection mailing.
3. Month Post Open Label Injection Visit:
Same as Visit 3.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Suspended |
NCT00194636 -
Effectiveness of Sympathetic Plexus Block on Male Pelvic Pain (Prostatitis, Prostatodynia)
|
Phase 4 |