Clinical Trials Logo
  1. Home
  2. Benign Prostatic Hyperplasia
  3. NCT01912339

Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate) — REZUM  

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Minimally Invasive Prostatic Vapor Ablation - Multicenter, Controlled Study for the Treatment of BPH (Rezūm II)

Clinical Trial Summary

To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).

Clinical Trial Description

This study is a prospective, controlled, randomized single blind clinical trial of subjects with benign prostatic hyperplasia, which will allow for an interim analysis for sample size adjustment. Subjects first will be randomized in a 2:1 proportion in favor of the Treatment arm. Subjects in the Control arm will be allowed to crossover to have the Rezūm treatment after the 3-month follow-up examination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01912339
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date July 2013
Completion date October 17, 2016
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04807296 - Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP) N/A
Recruiting NCT05574244 - Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction N/A
Recruiting NCT04288427 - 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy N/A
Not yet recruiting NCT04245566 - Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH Phase 3
Completed NCT03246880 - Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients Phase 3
Completed NCT02509975 - Safety and Efficacy of OCL 503 in Prostate Artery Embolization N/A
Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
Completed NCT02206243 - Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
Completed NCT02283684 - GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT Phase 4
Completed NCT01454349 - Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH) Phase 1/Phase 2
Completed NCT01438775 - Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) Phase 3
Completed NCT01139762 - A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms Phase 3
Completed NCT01152190 - A Study in Benign Prostatic Hyperplasia Phase 3
Active, not recruiting NCT00400894 - Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma N/A
Unknown status NCT00381108 - Study of the Effects of Pomegranate Tablets on Enlarged Prostates Phase 1
Completed NCT00701779 - Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia Phase 4
Completed NCT00224133 - The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months Phase 3
Terminated NCT02962674 - To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH. N/A
Active, not recruiting NCT05415748 - Deprescribing Tamsulosin in Older Men Phase 4
Recruiting NCT04853914 - Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound. N/A