N/A
Completed N=22
To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China
Benign Prostatic Hyperplasia (BPH)
Source: ClinicalTrials.gov NCT04823221 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: International Prostate Symptom Score (IPSS) Change From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure. — 14.9 scores on a scale
Summary
A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY International Prostate Symptom Score (IPSS) Change From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure. |
14.9 | — |
| PRIMARY Device Related Serious Complications From Rezūm Procedure to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure. |
— | — |
| SECONDARY Rezūm Procedure Time |
3.9 | — |
| SECONDARY Length of Catheterization |
4.8 | — |
| SECONDARY The Change of Peak Flow Rate (Qmax) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure. |
13.3 | — |
| SECONDARY Post Void Residual Urine Volume (PVR） |
11.6 | — |
| SECONDARY Quality of Life (Qol) |
2.5 | — |
| SECONDARY Ejective Function (MSHQ-EjD) |
2.6 | — |
| SECONDARY The Change of International Index of Erectile Function(IIEF) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 |
2.7 | — |
Eligibility Criteria
Inclusion Criteria
- The subjects will provide written informed consent form and agree to data collection.
- The subjects who were diagnosed as BPH and treated by Rezūm procedure in Hainan medical pilot zone will be enrolled in this study.
Exclusion Criteria
- This is a retrospective study without any formal exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT04823221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.