drugset / Trial / NCT06867315
The Safety and Effectiveness of Steep Pulse Therapy System for the Ablation of Benign Prostatic Hyperplasia
Recruiting
10 enrolled
First Affiliated Hospital of Zhejiang University
First People's Hospital of Hangzhou · collabFujian Provincial Hospital · collabShanghai Jiao Tong University Affiliated Sixth People's Hospital · collabThe First Affiliated Hospital of University of Science and Technology of China · collab
RandomizedParallel-groupOpen-labelDevice feasibility
Summary
The goal of this clinical trial is to assess the efficacy of steep pulse ablation in treating benign prostatic hyperplasia (BPH) and to evaluate its safety profile in treating BPH. The main questions it aims to answer are: 1. whether steep pulse ablation can effectively manage BPH symptoms and to investigate any potential safety concerns associated with its use in treating BPH. 2. If steep pulse ablation can perform superior effect than Tamsulosin Hydrochloride in treating BPH. Participants will be asked to do: 1. Participants will be given Tamsulosin Hydrochloride or undergo steep pulse ablation. 2. Participants will be followed up after 1 month and 3 month after taking drug or undergo ablation for test and relative examinations.
Timeline
- Start
- 2024-05-29
- Primary completion
- 2026-05-29
- Completion
- 2026-05-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tamsulosin | Other / unclassified | 0.2 mg | — |