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

NCT04838769 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Benign Prostatic Hyperplasia (BPH)

Interventions

DEVICE

REZŪM

Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use.

DRUG

alpha blocker and 5-alpha reductase inhibitor

Subjects assigned to dual drug therapy will be treated with the local formulary preferred choice of commercially available urinary selective alpha blocker and 5-alpha reductase inhibitor. This arm will therefore represent local standard of care.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Romain Mathieu, Professor · CHU Rennes, Hôpital Pontchaillou

  • Evanguelos Xylinas, Ass. Prof. · Hôpital Bichat

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2025-12-11
Completion
2027-03-31
FDA Device
Yes

Countries

  • Australia
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04838769 on ClinicalTrials.gov