Botulinum Toxin Type A for the Treatment of Male Chronic Pelvic Pain Syndrome
TerminatedPhase 3NCT00464373
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Injection of Botulinum Toxin Type A Into the External Urethral Sphincter for Male Patients Suffering From Chronic Prostatitis/Chronic Pelvic Pain Syndrome (NIH Cat. III): a Prospective, Double-blind and Placebo-controlled Clinical Trial
- Interventions
- Sponsor
- Daniel Stephan Engeler
- Collaborators
- Allergan
- Organization
- Cantonal Hospital of St. Gallen
- Start date
- 2007-04
- Primary completion
- 2013-05
- Sex
- Male
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- Switzerland
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 during last 5 years * Any disease that may influence the results according to the opinion of the medical doctor
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00464373