NCT00464373

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Daniel Stephan Engeler · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 the major problems is the unknown pathomechanism of the disease. Most patients are suffering from irritative voiding symptoms and a dysfunction of the pelvic floor. By looking at the various (non-) conservative therapeutical strategies it becomes quite clear that there is no unique and convincing therapeutical strategy. At present Botulinum-Toxin Type A (BTX A) is widely used in the urological field especially for para-/tetraplegics patients having trouble with neurogenic bladder dysfunction. It has been reported in case series (doses: 200U and 30U) that BTX A injected into the external urethral sphincter is able to reduce the symptoms without provoking incontinence. This is implied with the hypothesis that obstructive voiding symptoms because of a CP/CPPS are associated with an incomplete relaxation of the bladder neck and the external urethral sphincter. After having given their informed consent, patients undergo a screening visit and baseline evaluation including patients history, clinical examination, NIH-CPSI and IPSS-questionnaires, micturition diary, sonography, 4-glass test and urodynamics. Patients fulfilling the study eligibility criteria are randomized to receive intrasphincteric injection of either BTX A or placebo. There will be 5 follow-up visits including a post-treatment follow-up after 1 year.

Conditions

• Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Prostatitis

Interventions

Type	Name	Description
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%

Timeline

• Start date: 2007-04-01
• Primary completion: 2013-05-01
• Completion: 2013-06-01
• First posted: 2007-04-23
• Last updated: 2014-02-03

Locations

1 site across 1 country: Switzerland