ISRCTN42633050
Completed
Not Applicable
Clinical and histologic effect of transrectal intraprostatic injections with botulinum toxin A in patients with lower urinary tract symptoms caused by benign prostatic hyperplasia
niversity Medical Center Utrecht (UMCU) (The Netherlands)0 sites20 target enrollmentNovember 22, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Benign prostatic hyperplasia
- Sponsor
- niversity Medical Center Utrecht (UMCU) (The Netherlands)
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age more than 55
- •2\. Signed informed consent
- •3\. Lower Urinary Tract Symptoms (LUTS) with International Prostatic Symptom Score (IPSS) more than seven
- •4\. Insufficient response to oral medication
- •5\. Prostatic volume 30 to 50 ml
- •6\. Urodynamic infravesical obstruction more than grade II according to Schafer
- •7\. Willing and able to fill out questionnaires and voiding diaries
- •8\. Willing and able to attend proposed investigations
Exclusion Criteria
- •1\. Neuropathic bladder dysfunction
- •2\. Prostatic carcinoma
- •3\. Coagulation disorder
- •4\. Urinary tract infection
- •5\. Bladder calculus
- •6\. Post\-renal renal insufficiency
- •7\. Myopathic disorder
- •8\. Anatomical defects preventing transrectal approach
Outcomes
Primary Outcomes
Not specified
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