Clinical Trials Logo
  1. Home
  2. Prostatitis
  3. NCT00464373

Botulinum Toxin Type A for the Treatment of Male Chronic Pelvic Pain Syndrome — BTX-URO-01  

Prostatitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00464373
Study type Interventional
Source Cantonal Hospital of St. Gallen
Contact
Status Terminated
Phase Phase 3
Start date April 2007
Completion date June 2013
View Details
See also
  Status Clinical Trial Phase
Completed NCT02246361 - Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication Phase 4
Recruiting NCT00775515 - Laparoscopic Prostatectomy for Chronic Prostatitis Phase 2
Withdrawn NCT03027076 - Microbiome of Urologic Chronic Pelvic Pain Syndrome N/A
Completed NCT00402688 - An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis Phase 3
Suspended NCT00194636 - Effectiveness of Sympathetic Plexus Block on Male Pelvic Pain (Prostatitis, Prostatodynia) Phase 4
Recruiting NCT03720951 - Applying Pulsed Radiofrequency to the Pudendal Nerve Bilaterally Vs Its Application to Sacral Nerve Roots S2,3 and 4 Bilaterally in Chronic Prostatitis N/A
Completed NCT03879486 - Infectious Outcomes of Povidone-iodine Rectal Cleansing Plus Formalin Disinfection of Needle During Prostate Biopsy N/A
Completed NCT01676857 - Chemokine Mechanisms in Chronic Pelvic Pain
Completed NCT00236808 - A Study to Evaluate the Safety and Effectiveness of Levofloxacin Compared With Ciprofloxacin in Patients With Chronic Bacterial Prostatitis Phase 3
Completed NCT00169585 - Levofloxacin For The Management Of Patients With Abnormal Prostate Specific Antigen (PSA) Phase 3
Completed NCT00277511 - Levofloxacin, Chronic Bacterial Prostatitis Phase 3
Completed NCT01886547 - 2013 Annual National Digital Rectal Exam (DRE) Day Study N/A
Completed NCT00701311 - An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome Phase 2
Terminated NCT00194597 - Trial of Viagra' in Men With Chronic Pelvic Pain Syndrome Type III Phase 4
Completed NCT03931538 - Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study N/A
Terminated NCT00529386 - Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) Phase 1
Completed NCT00675298 - Linkage Analysis in Interstitial Cystitis N/A
Completed NCT00103402 - Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome Phase 3
Completed NCT00260637 - Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis Phase 2/Phase 3
Recruiting NCT01932645 - Etiology Study of Prostatitis