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

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”

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.

Intervention(s) in this Clinical Trial

• 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%

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Botulinum Toxin Type A 200 U in 4ml NaCl 0.9%
• Placebo Comparator: 2
  • 4ml NaCl 0.9%

Primary Measures

• NIH-CPSI Total Score
  • Time Frame: 1 year
    Safety Issue?: No

Secondary Measures

• NIH-CPSI Subscales
  • Time Frame: 1 year
    Safety Issue?: No
• Standardized questions for the assessment of the treatment outcome
  • Time Frame: 1 year
    Safety Issue?: No
• International prostate symptom score (I-PSS)
  • Time Frame: 1 year
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Cantonal Hospital of St. Gallen Other

Overall Clinical Trial Officials and Contacts

Daniel S Engeler, MD Principal Investigator Department of Urology, Cantonal Hospital of St. Gallen, St. Gallen, Switzerland  

Overall Contact: Daniel S Engeler, MD +41714941430 daniel.engeler@kssg.ch

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00464373

Study ID Number: BTX-URO-01

ClinicalTrials.gov Identifier: NCT00464373

Health Authority: Switzerland: Swissmedic