Status:
TERMINATED
Botulinum Toxin Type A for the Treatment of Male Chronic Pelvic Pain Syndrome
Lead Sponsor:
Daniel Stephan Engeler
Collaborating Sponsors:
Allergan
Conditions:
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Prostatitis
Eligibility:
MALE
18-70 years
Phase:
PHASE3
Brief 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 trea...
Detailed Description
The treatment of the male CP/CPPS is often as unsuccessful as frustrating for patients and doctors. Because of that patients change their general practitioners or urologists quite regularly. One of th...
Eligibility Criteria
Inclusion
- CPPS NIH III (symptoms over 3 months during the last 6 months, 4 glass-test)
- Pain Score ≥ 4
Exclusion
- 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 during last 5 years
- Any disease that may influence the results according to the opinion of the medical doctor
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00464373
Start Date
April 1 2007
End Date
June 1 2013
Last Update
February 3 2014
Active Locations (1)
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1
Department of Urology, Cantonal Hospital of St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007