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

NCT ID: NCT04838769

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2027-03-31

Brief 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.

Detailed 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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

REZŪM

Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use (IFU). The REZŪM System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men with a prostate volume ≥ 30 ml. The REZŪM System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

1:1 randomization will occur via the electronic data capture (EDC) system.

Group Type: ACTIVE_COMPARATOR

REZŪM

Intervention Type: DEVICE

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

Dual Drug Therapy

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.

Group Type: ACTIVE_COMPARATOR

alpha blocker and 5-alpha reductase inhibitor

Intervention Type: DRUG

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.

Interventions

REZŪM

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

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Other Intervention Names

Dual Drug Therapy

Eligibility Criteria

Inclusion Criteria

1. Sexually active male subjects ≥ 45 years of age who have persistent non-neurogenic lower urinary tract symptoms refractory to first-line treatment with single agent Alpha Adrenoceptor Antagonist therapy

2. Subject is willing and able to answer all domains of MSHQ

3. Completed IPSS questionnaire with score ≥ 13 within 6 months prior to enrollment

4. Peak urinary flow rate (Qmax): ≤ 15 ml/sec with minimum voided volume of ≥ 150 ml within 6 months prior to enrollment

5. Post-void residual (PVR) ≤250 ml within 6 months prior to enrollment

6. Prostate volume ≥ 30 ml as measured by transrectal ultrasound or Magnetic Resonance Imaging within 3 months prior to enrollment

7. Subject is willing and capable of providing informed consent

8. Subject is willing and capable of participating in all visits associated with this study at an approved clinical study site and at the intervals defined by this Clinical Investigational Plan (CIP)

9. France subjects only: subjects must be affiliated to national security insurance

Exclusion Criteria

1. Inability to participate in full duration of study

2. Prior surgical treatment for BPH

3. Increased risk of bleeding

4. Presence of Genitourinary Cancer or other pelvic cancer

5. Functional issues with bladder

6. Presence of active infection in genitourinary tract

7. Structural and Anatomic issues with urinary tract and renal function

8. Concomitant Drug Therapy

9. Temporal restraints and risks for general anaesthesia or comorbidity that would elevate risk of participation

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Romain Mathieu, Professor

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes, Hôpital Pontchaillou

Evanguelos Xylinas, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bichat

Locations

Epworth Healthcare

Melbourne, , Australia

Australian Clinical Trials

Wahroonga, , Australia

Centre Hospitalier du Pays d'Aix

Aix-en-Provence, , France

CHU d'Angers

Angers, , France

CHU de Bordeaux

Bordeaux, , France

CHU Grenoble

Grenoble, , France

Centre Hospitalier Universitaire de Lille

Lille, , France

Hôpital Privé La Louvière

Lille, , France

Hospices Civils de Lyon

Lyon, , France

CHU de Nice

Nice, , France

Hôpital Bichat

Paris, , France

Hôpital Cochin

Paris, , France

Institut Mutualiste Montsouris

Paris, , France

Hôpital privé Francheville

Périgueux, , France

Clinique La Croix du Sud

Quint-Fonsegrives, , France

CHU de Rennes

Rennes, , France

CHU de Rouen

Rouen, , France

Clinique Saint Hilaire

Rouen, , France

Centre Hospitalier Privé Saint Grégoire

Saint-Grégoire, , France

CHU de Toulouse

Toulouse, , France

Clinique Pasteur

Toulouse, , France

Countries

Australia; France

Other Identifiers

U0693

Identifier Type: -

Identifier Source: org_study_id