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

NCT00464373 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2014-02-03

No results posted yet for this study

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.

Conditions

  • Chronic Prostatitis With Chronic Pelvic Pain Syndrome
  • Prostatitis

Interventions

DRUG

Botulinum Toxin Type A

Single intrasphincteric injection at the 3,6,9, and 12 o'clock positions of the external urethral sphincter (1 ml of drug solution each)

DRUG

Placebo

4ml NaCl 0.9%

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Daniel Stephan Engeler

    lead OTHER

Principal Investigators

  • Daniel S Engeler, MD · Department of Urology, Cantonal Hospital of St. Gallen, St. Gallen, Switzerland

  • Hans-Peter Schmid, MD · Department of Urology, Cantonal Hospital of St. Gallen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2013-05-31
Completion
2013-06-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00464373 on ClinicalTrials.gov