Botulinum Toxin Type A for the Treatment of Male Chronic Pelvic Pain Syndrome

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel Stephan Engeler
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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