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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00464373
Recruitment Status : Terminated (Slow accrual.)
First Posted : April 23, 2007
Last Update Posted : February 3, 2014
Information provided by (Responsible Party):
Daniel Stephan Engeler, Cantonal Hospital of St. Gallen

April 20, 2007
April 23, 2007
February 3, 2014
April 2007
May 2013   (Final data collection date for primary outcome measure)
NIH-CPSI Total Score [ Time Frame: 1 year ]
NIH-CPSI Total Score
Complete list of historical versions of study NCT00464373 on Archive Site
  • NIH-CPSI Subscales [ Time Frame: 1 year ]
  • Standardized questions for the assessment of the treatment outcome [ Time Frame: 1 year ]
  • International prostate symptom score (I-PSS) [ Time Frame: 1 year ]
  • Proportion of patients with a minimal reduction of 25% of their symptoms according to the NIH-CPSI Total Score
  • NIH-CPSI Subscales
  • Standardized questions for the assessment of the treatment outcome
  • International prostate symptom score (I-PSS)
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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
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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Prostatitis With Chronic Pelvic Pain Syndrome
  • Prostatitis
  • 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
  • Drug: Placebo
    4ml NaCl 0.9%
  • Experimental: 1
    Botulinum Toxin Type A 200 U in 4ml NaCl 0.9%
    Intervention: Drug: Botulinum Toxin Type A
  • Placebo Comparator: 2
    4ml NaCl 0.9%
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
EKSG 06/056
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Daniel Stephan Engeler, Cantonal Hospital of St. Gallen
Daniel Stephan Engeler
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
Cantonal Hospital of St. Gallen
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP