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

Benign Prostatic Hyperplasia (BPH) Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04838769
• Other study ID #: U0693
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: Boston Scientific Corporation
• Contact: Caroline Beaudoint
• Phone: +32479904163
• Email: Caroline.Beaudoint[@]bsci.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 394
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• REZUM
Subjects randomized to receive the REZUM treatment will receive standardized treatment, following the Instruction for Use.

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.

Locations

Country	Name	City	State
Australia	Epworth Healthcare	Melbourne
Australia	Australian Clinical Trials	Wahroonga
France	Centre Hospitalier du Pays d'Aix	Aix-en-Provence
France	CHU d'Angers	Angers
France	CHU de Bordeaux	Bordeaux
France	CHU Henri Mondor	Créteil
France	CHU Grenoble	Grenoble
France	Centre Hospitalier Universitaire de Lille	Lille
France	Hôpital Privé La Louvière	Lille
France	Hospices Civils de Lyon	Lyon
France	CHU de Nice	Nice
France	Fondation Hôpital Saint-Joseph	Paris
France	Hôpital Bichat	Paris
France	Hôpital Cochin	Paris
France	Institut Mutualiste Montsouris	Paris
France	Hôpital privé Francheville	Perigueux
France	Clinique La Croix du Sud	Quint-Fonsegrives
France	CHU de Rennes	Rennes
France	CHU de Rouen	Rouen
France	Clinique Saint Hilaire	Rouen
France	Centre Hospitalier Privé Saint Grégoire	Saint-Grégoire
France	CHU de Toulouse	Toulouse
France	Clinique Pasteur	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Australia,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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