Botulinum Toxin Type A for the Treatment of Male Chronic Pelvic Pain Syndrome (NCT00464373) | Clinical Trial Compass
TerminatedPhase 3
Botulinum Toxin Type A for the Treatment of Male Chronic Pelvic Pain Syndrome
Stopped: Slow accrual.
Switzerland11 participantsStarted 2007-04
Plain-language summary
The aim of this randomized placebo-controlled study is to demonstrate the efficiency and safety of the injection of Botulinum Toxin Type A (200 Units) into the external urethral sphincter for the treatment of chronic prostatitis/chronic pelvic pain.
Who can participate
Age range18 Years – 70 Years
SexMALE
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Inclusion Criteria:
* CPPS NIH III (symptoms over 3 months during the last 6 months, 4 glass-test)
* Pain Score ≥ 4
Exclusion Criteria:
* During the last month: intake of antibiotics, alpha receptor blockers, anticholinergics; intake of analgesics containing opioids (longer than 4 days); participating in a different clinical trial
* During the last 3 months:documented urinary infection, epididymitis, positive urinary culture; status post biopsy of the prostate gland; STD: Gonorrhea, Chlamydia, Mycoplasm, Trichomonads
* During the last 6 months: Finasteride or any other 5α-reductase inhibitor
* During the last 12 months: status post any surgery on the prostate gland; genital herpes; not adjustable hypertension, angina pectoris, heart failure (NYHA III-IV), Status post myocardial infarction, coronary bypass surgery or coronary dilatation
* During the last 24 months: cerebral insult, TIA; active disease of the liver
* Other urological diseases like prostate cancer, bladder cancer, status post radiation of the small pelvis, chemotherapy (intravesical or systemic)
* Urinary catheter
* Residual urine \> 200ml
* Serum creatinine \> 200µmol/l
* Status post injection of BTX A, hypersensitivity concerning any substances of content of BTX, myasthenia gravis
* Any kind of cancer
* Active inflammation (except the prostate gland)
* Neurological or psychological disease making signing of a consent form or behaving according to a study protocol impossible
* Abuse of drugs or alcohol durin…