Clinical and histologic effect of transrectal intraprostatic injections with botulinum toxin in patients with lower urinary tract symptoms caused by benign prostatic hyperplasia.
Phase 2
Completed
- Conditions
- benign prostatic hyperplasiaprostatic enlargement10018188
- Registration Number
- NL-OMON30514
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
lower urinary tract symptoms
IPSS (international prostatic symptom score) > 7
prostatic volume 30-50 ml
urodynamic infravesical obstruction > grade II according to Schafer
Exclusion Criteria
neuropathic bladder dysfunction
prostatic carcinoma
coagulation disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Symptom relief (IPSS).<br /><br>Urodynamic obstruction (according to Schafer)<br /><br>Histologic changes after 1 month</p><br>
- Secondary Outcome Measures
Name Time Method <p>Post void residual<br /><br>Decrease of prostate volume<br /><br>Change in PSA<br /><br>Other treatment needed</p><br>