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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Prostatitis

Intervention / Treatment
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* Drug: Botulinum Toxin Type A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Botulinum Toxin Type A 200 U in 4ml NaCl 0.9% | Drug: Botulinum Toxin Type A<br>* Single intrasphincteric injection at the 3,6,9, and 12 o'clock positions of the external urethral sphincter (1 ml of drug solution each)<br>* Other names: Botox;|
| Placebo Comparator: 2<br>4ml NaCl 0.9% | Drug: Placebo<br>* 4ml NaCl 0.9%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH-CPSI Total Score |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH-CPSI Subscales |  | 1 year | 
| Standardized questions for the assessment of the treatment outcome |  | 1 year | 
| International prostate symptom score (I-PSS) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatitis, Chronic Prostatitis with Chronic Pelvic Pain Syndrome, Botulinum Toxin Type A, Drug therapy, Injections, intramuscular