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

Not Applicable

Active, not recruiting

• Conditions: Benign Prostatic Hyperplasia (BPH)
• Interventions: Device: REZŪM; Drug: alpha blocker and 5-alpha reductase inhibitor

• Registration Number: NCT04838769
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-09
• Study Start: 2021-09-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-02
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REZŪM	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.
Dual Drug Therapy	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.

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS) change	From Baseline to 12 months	Primary Statistical Hypothesis: Change in IPSS score will be compared between groups. IPSS score ranges from 0 to 35 with higher scores indicating worse symptoms.
Male Sexual Health Questionnaire (MSHQ) total score change	From Baseline to 12 months	Change in MHSQ score will be compared between groups. MHSQ score ranges from 0 to 125 with higher scores indicating better outcomes.

Secondary Outcome Measures

Name	Time	Method
Disease Progression	End of available follow-up, up to 24 months	Disease progression, defined as occurrence of any of the following: * Surgical retreatment for LUTS/BPH; * Urinary retention requiring urinary catheterization after 90 days post-treatment; * IPSS increase from baseline by ≥ 4 points; * Introduction of a new drug agent to treat LUTS/BPH

Trial Locations

Locations (21)

Centre Hospitalier du Pays d'Aix; 🇫🇷 Aix-en-Provence, France

CHU d'Angers; 🇫🇷 Angers, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU Grenoble; 🇫🇷 Grenoble, France

Epworth Healthcare; 🇦🇺 Melbourne, Australia

Australian Clinical Trials; 🇦🇺 Wahroonga, Australia

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; 🇫🇷 Perigueux, 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