- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00464373
Botulinum Toxin Type A for the Treatment of Male Chronic Pelvic Pain Syndrome (BTX-URO-01)
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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St. Gallen, Switzerland, 9007
- Department of Urology, Cantonal Hospital of St. Gallen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Botulinum Toxin Type A 200 U in 4ml NaCl 0.9%
|
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 Names:
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Placebo Comparator: 2
4ml NaCl 0.9%
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4ml NaCl 0.9%
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
NIH-CPSI Total Score
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
NIH-CPSI Subscales
Time Frame: 1 year
|
1 year
|
Standardized questions for the assessment of the treatment outcome
Time Frame: 1 year
|
1 year
|
International prostate symptom score (I-PSS)
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Pain
- Neurologic Manifestations
- Disease Attributes
- Disease
- Prostatic Diseases
- Syndrome
- Chronic Disease
- Somatoform Disorders
- Pelvic Pain
- Prostatitis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- BTX-URO-01
- EKSG 06/056
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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