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
Overview
- Phase
- Phase 3
- Intervention
- Botulinum Toxin Type A
- Conditions
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome
- Sponsor
- Daniel Stephan Engeler
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- NIH-CPSI Total Score
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
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.
Investigators
Daniel Stephan Engeler
Dr. med.
Cantonal Hospital of St. Gallen
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
Arms & Interventions
1
Botulinum Toxin Type A 200 U in 4ml NaCl 0.9%
Intervention: Botulinum Toxin Type A
2
4ml NaCl 0.9%
Intervention: Placebo
Outcomes
Primary Outcomes
NIH-CPSI Total Score
Time Frame: 1 year
Secondary Outcomes
- NIH-CPSI Subscales(1 year)
- Standardized questions for the assessment of the treatment outcome(1 year)
- International prostate symptom score (I-PSS)(1 year)