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

This study has been terminated.
(Slow accrual.)
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Daniel Stephan Engeler, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00464373
First received: April 20, 2007
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Prostatitis
Drug: Botulinum Toxin Type A
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • NIH-CPSI Total Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NIH-CPSI Subscales [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Standardized questions for the assessment of the treatment outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • International prostate symptom score (I-PSS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: April 2007
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Botulinum Toxin Type A 200 U in 4ml NaCl 0.9%
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)
Other Name: Botox
Placebo Comparator: 2
4ml NaCl 0.9%
Drug: Placebo
4ml NaCl 0.9%

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464373

Locations
Switzerland
Department of Urology, Cantonal Hospital of St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Daniel Stephan Engeler
Allergan
Investigators
Principal Investigator: Daniel S Engeler, MD Department of Urology, Cantonal Hospital of St. Gallen, St. Gallen, Switzerland
Study Director: Hans-Peter Schmid, MD Department of Urology, Cantonal Hospital of St. Gallen
  More Information

No publications provided

Responsible Party: Daniel Stephan Engeler, Dr. med., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00464373     History of Changes
Other Study ID Numbers: BTX-URO-01, EKSG 06/056
Study First Received: April 20, 2007
Last Updated: January 31, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Cantonal Hospital of St. Gallen:
Prostatitis
Chronic Prostatitis with Chronic Pelvic Pain Syndrome
Botulinum Toxin Type A
Drug therapy
Injections, intramuscular

Additional relevant MeSH terms:
Chronic Disease
Pelvic Pain
Prostatitis
Somatoform Disorders
Syndrome
Disease
Disease Attributes
Genital Diseases, Male
Mental Disorders
Pain
Pathologic Processes
Prostatic Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014