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

Prostatitis Clinical Trial

— BTX-URO-01  

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 Details — Status: Terminated

Administrative data

• NCT number: NCT00464373
• Other study ID #: BTX-URO-01
• Secondary ID: EKSG 06/056
• Status: Terminated
• Phase: Phase 3
• First received: April 20, 2007
• Last updated: January 31, 2014
• Start date: April 2007
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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 5a-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

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

• Chronic Disease
• Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

Intervention

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)
• Placebo
4ml NaCl 0.9%

Locations

Country	Name	City	State
Switzerland	Department of Urology, Cantonal Hospital of St. Gallen	St. Gallen

Sponsors (2)

Lead Sponsor	Collaborator
Daniel Stephan Engeler	Allergan

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIH-CPSI Total Score		1 year	No
Secondary	NIH-CPSI Subscales		1 year	No
Secondary	Standardized questions for the assessment of the treatment outcome		1 year	No
Secondary	International prostate symptom score (I-PSS)		1 year	No