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

NCT ID: NCT00464373

Last Updated: 2014-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2013-06-30

Brief 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.

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.

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Prostatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Botulinum Toxin Type A 200 U in 4ml NaCl 0.9%

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

Single intrasphincteric injection at the 3,6,9, and 12 o'clock positions of the external urethral sphincter (1 ml of drug solution each)

2

4ml NaCl 0.9%

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

4ml NaCl 0.9%

Interventions

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)

Intervention Type: DRUG

Placebo

4ml NaCl 0.9%

Intervention Type: DRUG

Other Intervention Names

Botox

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Daniel Stephan Engeler

OTHER

Sponsor Role: lead

Responsible Party

Daniel Stephan Engeler

Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Daniel S Engeler, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Cantonal Hospital of St. Gallen, St. Gallen, Switzerland

Hans-Peter Schmid, MD

Role: STUDY_DIRECTOR

Department of Urology, Cantonal Hospital of St. Gallen

Locations

Department of Urology, Cantonal Hospital of St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Countries

Switzerland

Other Identifiers

EKSG 06/056

Identifier Type: -

Identifier Source: secondary_id

BTX-URO-01

Identifier Type: -

Identifier Source: org_study_id