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

• ClinicalTrials.gov Identifier: NCT04838769
• Recruitment Status: Recruiting
• First Posted: April 9, 2021
• Last Update Posted: March 2, 2022
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Benign Prostatic Hyperplasia (BPH)	Device: REZŪM; Drug: alpha blocker and 5-alpha reductase inhibitor	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 394 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: September 15, 2021
• Estimated Primary Completion Date: January 2024
• Estimated Study Completion Date: January 2025

Arms and Interventions

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 Name: Dual Drug Therapy

Outcome Measures

Primary Outcome Measures :

1. International Prostate Symptom Score (IPSS) change [ Time Frame: 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.
2. Male Sexual Health Questionnaire (MSHQ) total score change [ Time Frame: 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 :

1. Disease Progression [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Sexually active male subjects
• Accepts Healthy Volunteers: No

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. IPSS score ≥ 13 within 6 months prior to enrollment
4. Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 15 ml/sec with minimum voided volume of ≥ 150 ml within 6 months prior to enrollment on two separate measurements
5. Post-void residual (PVR) ≤250 ml within 6 months prior to enrollment
6. Prostate volume ≥ 30 ml as measured by transrectal ultrasound 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

Contacts and Locations

Contacts

Contact: Caroline Beaudoint; +32479904163; Caroline.Beaudoint@bsci.com

Contact: Teresa Takle-Flach; +19529306000; Teresa.Takle-Flach@bsci.com

Locations

France

Centre Hospitalier du Pays d'Aix; Recruiting

Aix-en-Provence, France

Principal Investigator: Marc Fourmarier, Dr.

Centre Hospitalier Universitaire de Lille; Not yet recruiting

Lille, France

Principal Investigator: Jonathan Olivier, Dr.

Clinique La Croix du Sud; Recruiting

Quint-Fonsegrives, France

Principal Investigator: Ambroise Salin, Dr.

CHU de Rennes; Recruiting

Rennes, France

Principal Investigator: Romain Mathieu, Pr.

Clinique Saint Hilaire; Recruiting

Rouen, France

Principal Investigator: Ismaël Galliot, Dr.

Centre Hospitalier Privé Saint Grégoire; Recruiting

Saint-Grégoire, France

Principal Investigator: Sébastien Vincendeau, Dr.

Clinique Pasteur; Recruiting

Toulouse, France

Principal Investigator: Vincent Misrai, Dr.

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

• Principal Investigator: Romain Mathieu, Professor; CHU Rennes, Hôpital Pontchaillou
• Principal Investigator: Evanguelos Xylinas, Ass. Prof.; Hôpital Bichat

More Information

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT04838769
• Other Study ID Numbers: U0693
• First Posted: April 9, 2021
• Last Update Posted: March 2, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Boston Scientific Corporation:

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

Additional relevant MeSH terms:

Prostatic Hyperplasia; Hyperplasia; Pathologic Processes; Prostatic Diseases; Adrenergic alpha-Antagonists; 5-alpha Reductase Inhibitors; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists