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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Device: REZŪM; Drug: alpha blocker and 5-alpha reductase inhibitor

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 Type: Interventional
• Enrollment (Estimated): 394
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Beaudoint; Phone Number: +32479904163; Email: Caroline.Beaudoint@bsci.com
• Study Contact Backup: Name: Teresa Takle-Flach; Phone Number: +19529306000; Email: Teresa.Takle-Flach@bsci.com

Study Locations

• Australia
  • Melbourne, Australia
    • Recruiting
    • Epworth Healthcare
    • Principal Investigator: Paul Anderson, Dr.
  • Wahroonga, Australia
    • Not yet recruiting
    • Australian Clinical Trials
    • Principal Investigator: James Symons, Dr.
• France
  • Aix-en-Provence, France
    • Recruiting
    • Centre Hospitalier du Pays d'Aix
    • Principal Investigator: Marc Fourmarier, Dr.
  • Angers, France
    • Recruiting
    • CHU d'Angers
    • Principal Investigator: Souhil Lebdai, Pr.
  • Bordeaux, France
    • Recruiting
    • CHU de Bordeaux
    • Principal Investigator: Grégoire Robert, Pr.
  • Créteil, France
    • Not yet recruiting
    • CHU Henri Mondor
    • Principal Investigator: Alexandre de la Taille, Pr.
  • Grenoble, France
    • Recruiting
    • CHU Grenoble
    • Principal Investigator: Quentin Franquet, Dr.
  • Lille, France
    • Recruiting
    • Centre Hospitalier Universitaire de Lille
    • Principal Investigator: Jonathan Olivier, Dr.
  • Lille, France
    • Recruiting
    • Hôpital Privé La Louvière
    • Principal Investigator: Charles Ballereau, Dr.
  • Lyon, France
    • Recruiting
    • Hospices Civils de Lyon
    • Principal Investigator: Hakim Fassi-Fehri, Dr.
  • Nice, France
    • Recruiting
    • CHU de Nice
    • Principal Investigator: Matthieu Durand, Pr.
  • Paris, France
    • Recruiting
    • Hopital Cochin
    • Principal Investigator: Nicolas Barry Delongchamps, Pr.
  • Paris, France
    • Recruiting
    • Institut Mutualiste Montsouris
    • Principal Investigator: Eric Barret, Dr.
  • Paris, France
    • Recruiting
    • Hôpital Bichat
    • Principal Investigator: Evanguelos Xylinas, Pr.
  • Paris, France
    • Not yet recruiting
    • Fondation Hôpital Saint-Joseph
    • Principal Investigator: Quentin Manach, Dr.
  • Perigueux, France
    • Recruiting
    • Hôpital privé Francheville
    • Principal Investigator: Richard Mallet, Dr.
  • Quint-Fonsegrives, France
    • Recruiting
    • Clinique La Croix du Sud
    • Principal Investigator: Ambroise Salin, Dr.
  • Rennes, France
    • Recruiting
    • CHU de Rennes
    • Principal Investigator: Romain Mathieu, Pr.
  • Rouen, France
    • Recruiting
    • CHU de Rouen
    • Principal Investigator: Jean-Nicolas Cornu, Pr.
  • Rouen, France
    • Recruiting
    • Clinique Saint Hilaire
    • Principal Investigator: Ismaël Galliot, Dr.
  • Saint-Grégoire, France
    • Recruiting
    • Centre Hospitalier Privé Saint Grégoire
    • Principal Investigator: Sébastien Vincendeau, Dr.
  • Toulouse, France
    • Recruiting
    • Clinique Pasteur
    • Principal Investigator: Vincent Misrai, Dr.
  • Toulouse, France
    • Recruiting
    • CHU de Toulouse
    • Principal Investigator: Florian Laclergerie, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: REZŪM; Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use.
Active Comparator: 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.	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.; Other Names: Dual Drug Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Progression	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	End of available follow-up, up to 24 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Romain Mathieu, Professor, CHU Rennes, Hôpital Pontchaillou; Principal Investigator: Evanguelos Xylinas, Ass. Prof., Hôpital Bichat

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Estimated): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Lower urinary tract symptoms; LUTS; Prostate; BPH; REZŪM; Water vapor thermotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Adrenergic alpha-Antagonists; 5-alpha Reductase Inhibitors
• Other Study ID Numbers: U0693

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes