Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04838769

REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men — VAPEUR RCT  

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:
Water Vapor Thermotherapy vs. Combination Pharmacotherapy for Symptomatic Benign Prostatic Hyperplasia Refractory to Alpha Blocker Monotherapy in Sexually Active Men: A Multicenter Randomized Controlled Trial

Clinical Trial Summary

The study objective is to compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.

Clinical Trial Description

STUDY OBJECTIVE - To compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men. STUDY DESIGN - Multicenter open-label randomized controlled parallel-group post-market trial. STUDY TREATMENTS AND RANDOMIZATION - Subjects will be randomly assigned to REZŪM or dual drug therapy treatments; 1:1 randomization via the electronic data capture (EDC) system. Both treatments are commercially available. Subjects randomized to receive the REZŪM treatment will receive standardized treatment and subjects randomized to dual drug therapy will receive the local formulary preferred choice of urinary selective alpha blocker and 5-alpha reductase inhibitor. VISIT SCHEDULE - Study visits are at: enrollment/baseline, treatment, 3 months, 6 months, and yearly follow-up through 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04838769
Study type Interventional
Source Boston Scientific Corporation
Contact Caroline Beaudoint
Phone +32479904163
Email Caroline.Beaudoint@bsci.com
Status Recruiting
Phase N/A
Start date September 15, 2021
Completion date October 2026
View Details
See also
  Status Clinical Trial Phase
Completed NCT03052049 - Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres N/A
Recruiting NCT04757116 - Post-Market Study to Assess iTind Safety in Comparison to UroLift N/A
Completed NCT03460873 - Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate
Completed NCT01218243 - An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia Phase 2
Completed NCT01566292 - Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy Phase 2/Phase 3
Active, not recruiting NCT00407953 - PROLIEVE® Post-Marketing Study TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) Phase 4
Completed NCT03191734 - French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue N/A
Completed NCT03856242 - Benign Prostatic Hyperplasia and Ischemic Heart DIsease Phase 4
Completed NCT04032067 - Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH) Phase 3
Completed NCT02505919 - Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER) N/A
Completed NCT02855892 - A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH Phase 2
Completed NCT02145208 - Study to Assess the Efficacy of Medi-Tate iTind Device N/A
Completed NCT00970632 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Phase 3
Recruiting NCT02592473 - Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia N/A
Completed NCT00945490 - Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018 Phase 3
Completed NCT00759135 - Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate) Phase 2
Completed NCT00224107 - A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo Phase 3
Recruiting NCT04648176 - Application of MOSES Technology in BPH N/A
Terminated NCT00651807 - A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806) Phase 2
Recruiting NCT04766268 - Prostate Artery Embolization: Single Center Experience N/A