Prospective randomized study on non-inferiority analysis/equivalence analysis of the surgical procedures GreenLight and Rezum for benign prostatic hyperplasia (AG BPH)
Not Applicable
Recruiting
- Conditions
- N40Hyperplasia of prostate
- Registration Number
- DRKS00034013
- Lead Sponsor
- Charite- Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 160
Inclusion Criteria
Capacity to consent
Exclusion Criteria
younger 18, female
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method REZUM demonstrates non-inferiority in subvesical deobstruction compared to GreenLight for <80cc prostates.<br>Difference in IPSS + QoL (pre-operative to 30 days post-operative).<br>Difference in IPSS + QoL (pre-operative to 1 year post-operative).
- Secondary Outcome Measures
Name Time Method REZUM demonstrates non-inferiority in subvesical deobstruction compared to GreenLight for >80cc prostates.<br><br>Retrograde Ejaculation<br>Recurrence of urinary retention (on XXth post-operative day)<br>Successful catheter removal (on XXth post-operative day)<br>Clavien-Dindo III-V (clinically relevant)<br>Recurrent infections<br>Surgical duration (to be differentiated in the table)<br>Discharge (on XXth post-operative day)