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

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04838769

Collaborator

(none)

394

Enrollment

Locations

Arms

51.5

Anticipated Duration (Months)

39.4

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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	N/A

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

Anticipated 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 :

Sep 15, 2021

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

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 Names: Dual Drug Therapy

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

Other Names:

Dual Drug Therapy

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	Country
1	Centre Hospitalier du Pays d'Aix	Aix-en-Provence	France
2	Centre Hospitalier Universitaire de Lille	Lille	France
3	Hôpital Bichat	Paris	France
4	Institut Mutualiste Montsouris	Paris	France
5	Hôpital privé Francheville	Perigueux	France
6	Clinique La Croix du Sud	Quint-Fonsegrives	France
7	CHU de Rennes	Rennes	France
8	Clinique Saint Hilaire	Rouen	France
9	Centre Hospitalier Privé Saint Grégoire	Saint-Grégoire	France
10	Clinique Pasteur	Toulouse	France

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

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