The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH). One of the limitations of the technology is the need for post-operative catheterization up to 5 days. The aim of this study is to assess the feasibility of employing Catheterless Rezum post-operatively in patients with normal or strong bladder contractility. Upon a positive outcome of interim analysis, the effectiveness of Catheterless Rezum will be assessed at five sites for the multicenter phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
20
The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH).
Weill Cornell Medicine
New York, New York, United States
Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS).
The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity.
Time frame: Baseline, 36 months
Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax).
The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction.
Time frame: Baseline, 36 months
Changes in urinary symptoms as measured by changes in IPSS.
The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity.
Time frame: Baseline, 36 months
Changes in urinary symptoms as measured by changes in Qmax at 36 months
The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction.
Time frame: Baseline, 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.