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

Primary Purpose

Benign Prostatic Hyperplasia (BPH)

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
REZŪM
alpha blocker and 5-alpha reductase inhibitor
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring Prostate, REZŪM, Water vapor thermotherapy, Lower urinary tract symptoms, BPH, LUTS

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Epworth Healthcare
  • Australian Clinical Trials
  • Centre Hospitalier du Pays d'AixRecruiting
  • CHU d'AngersRecruiting
  • CHU de BordeauxRecruiting
  • CHU Henri Mondor
  • CHU GrenobleRecruiting
  • Centre Hospitalier Universitaire de LilleRecruiting
  • Hôpital Privé La LouvièreRecruiting
  • Hospices Civils de LyonRecruiting
  • CHU de NiceRecruiting
  • Fondation Hôpital Saint-Joseph
  • Hôpital BichatRecruiting
  • Hôpital CochinRecruiting
  • Institut Mutualiste MontsourisRecruiting
  • Hôpital privé FranchevilleRecruiting
  • Clinique La Croix du SudRecruiting
  • CHU de RennesRecruiting
  • CHU de RouenRecruiting
  • Clinique Saint HilaireRecruiting
  • Centre Hospitalier Privé Saint GrégoireRecruiting
  • CHU de ToulouseRecruiting
  • Clinique PasteurRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

REZŪM

Dual Drug Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2021
Last Updated
October 20, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04838769
Brief Title
REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men
Acronym
VAPEUR RCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH)
Keywords
Prostate, REZŪM, Water vapor thermotherapy, Lower urinary tract symptoms, BPH, LUTS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
394 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REZŪM
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dual Drug Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
REZŪM
Intervention Description
Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use.
Intervention Type
Drug
Intervention Name(s)
alpha blocker and 5-alpha reductase inhibitor
Other Intervention Name(s)
Dual Drug Therapy
Intervention Description
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 Measure Information:
Title
International Prostate Symptom Score (IPSS) change
Description
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.
Time Frame
From Baseline to 12 months
Title
Male Sexual Health Questionnaire (MSHQ) total score change
Description
Change in MHSQ score will be compared between groups. MHSQ score ranges from 0 to 125 with higher scores indicating better outcomes.
Time Frame
From Baseline to 12 months
Secondary Outcome Measure Information:
Title
Disease Progression
Description
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
Time Frame
End of available follow-up, up to 24 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Sexually active male subjects
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Beaudoint
Phone
+32479904163
Email
Caroline.Beaudoint@bsci.com
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Takle-Flach
Phone
+19529306000
Email
Teresa.Takle-Flach@bsci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain Mathieu, Professor
Organizational Affiliation
CHU Rennes, Hôpital Pontchaillou
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evanguelos Xylinas, Ass. Prof.
Organizational Affiliation
Hôpital Bichat
Official's Role
Principal Investigator
Facility Information:
Facility Name
Epworth Healthcare
City
Melbourne
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Anderson, Dr.
Facility Name
Australian Clinical Trials
City
Wahroonga
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Symons, Dr.
Facility Name
Centre Hospitalier du Pays d'Aix
City
Aix-en-Provence
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Fourmarier, Dr.
Facility Name
CHU d'Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Souhil Lebdai, Pr.
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire Robert, Pr.
Facility Name
CHU Henri Mondor
City
Créteil
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre de la Taille, Pr.
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quentin Franquet, Dr.
Facility Name
Centre Hospitalier Universitaire de Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Olivier, Dr.
Facility Name
Hôpital Privé La Louvière
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Ballereau, Dr.
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hakim Fassi-Fehri, Dr.
Facility Name
CHU de Nice
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu Durand, Pr.
Facility Name
Fondation Hôpital Saint-Joseph
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quentin Manach, Dr.
Facility Name
Hôpital Bichat
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evanguelos Xylinas, Pr.
Facility Name
Hôpital Cochin
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Barry Delongchamps, Pr.
Facility Name
Institut Mutualiste Montsouris
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Barret, Dr.
Facility Name
Hôpital privé Francheville
City
Perigueux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Mallet, Dr.
Facility Name
Clinique La Croix du Sud
City
Quint-Fonsegrives
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ambroise Salin, Dr.
Facility Name
CHU de Rennes
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain Mathieu, Pr.
Facility Name
CHU de Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Nicolas Cornu, Pr.
Facility Name
Clinique Saint Hilaire
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ismaël Galliot, Dr.
Facility Name
Centre Hospitalier Privé Saint Grégoire
City
Saint-Grégoire
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Vincendeau, Dr.
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Laclergerie, Dr.
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Misrai, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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