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

NCT04838769 | Active Not Recruiting FDA Device

• 1 other identifier: U0693
• Study Type: interventional
• Target: 155
• Locations: 2 countries
• Sites: 21

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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

Prostate; REZŪM; Water vapor thermotherapy; Lower urinary tract symptoms; BPH; LUTS

Outcome Measures

Primary Outcomes (2)

• International Prostate Symptom Score (IPSS) change

  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.

  From Baseline to 12 months

• Male Sexual Health Questionnaire (MSHQ) total score change

  Change in MHSQ score will be compared between groups. MHSQ score ranges from 0 to 125 with higher scores indicating better outcomes.

  From Baseline to 12 months

Secondary Outcomes (1)

• Disease Progression

  End of available follow-up, up to 24 months

Study Arms (2)

REZŪM

ACTIVE COMPARATOR

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.

Device: REZŪM

Dual Drug Therapy

ACTIVE COMPARATOR

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.

Drug: alpha blocker and 5-alpha reductase inhibitor

Interventions

REZŪM DEVICE

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

REZŪM

alpha blocker and 5-alpha reductase inhibitor 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.

Also known as: Dual Drug Therapy

Dual Drug Therapy

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Sexually active male subjects
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subject is willing and able to answer all domains of MSHQ
• Completed IPSS questionnaire with score ≥ 13 within 6 months prior to enrollment
• Peak urinary flow rate (Qmax): ≤ 15 ml/sec with minimum voided volume of ≥ 150 ml within 6 months prior to enrollment
• Post-void residual (PVR) ≤250 ml within 6 months prior to enrollment
• Prostate volume ≥ 30 ml as measured by transrectal ultrasound or Magnetic Resonance Imaging within 3 months prior to enrollment
• Subject is willing and capable of providing informed consent
• 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)
• France subjects only: subjects must be affiliated to national security insurance

You may not qualify if:

• Inability to participate in full duration of study
• Prior surgical treatment for BPH
• Increased risk of bleeding
• Presence of Genitourinary Cancer or other pelvic cancer
• Functional issues with bladder
• Presence of active infection in genitourinary tract
• Structural and Anatomic issues with urinary tract and renal function
• Concomitant Drug Therapy
• Temporal restraints and risks for general anaesthesia or comorbidity that would elevate risk of participation

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (21)

Epworth Healthcare

Melbourne, Australia

Location

Australian Clinical Trials

Wahroonga, Australia

Location

Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France

Location

CHU d'Angers

Angers, France

Location

CHU de Bordeaux

Bordeaux, France

Location

CHU Grenoble

Grenoble, France

Location

Centre Hospitalier Universitaire de Lille

Lille, France

Location

Hôpital Privé La Louvière

Lille, France

Location

Hospices Civils de Lyon

Lyon, France

Location

CHU de Nice

Nice, France

Location

Hôpital Bichat

Paris, France

Location

Hôpital Cochin

Paris, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

Hôpital privé Francheville

Périgueux, France

Location

Clinique La Croix du Sud

Quint-Fonsegrives, France

Location

CHU de Rennes

Rennes, France

Location

CHU de Rouen

Rouen, France

Location

Clinique Saint Hilaire

Rouen, France

Location

Centre Hospitalier Privé Saint Grégoire

Saint-Grégoire, France

Location

CHU de Toulouse

Toulouse, France

Location

Clinique Pasteur

Toulouse, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Adrenergic alpha-Antagonists; 5-alpha Reductase Inhibitors

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Romain Mathieu, Professor

  CHU Rennes, Hôpital Pontchaillou

  PRINCIPAL INVESTIGATOR

• Evanguelos Xylinas, Ass. Prof.

  Hôpital Bichat

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 9, 2021
• Study Start: September 15, 2021
• Primary Completion: December 11, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (19); AU (2)