Benign Prostatic Hyperplasia (BPH)VAPEURNCT04838769
REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men
A study testing REZŪM and alpha blocker and 5-alpha reductase inhibitor in people with Benign Prostatic Hyperplasia (BPH), run by Boston Scientific Corporation at 21 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- REZŪM and alpha blocker and 5-alpha reductase inhibitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 15 Sep 2021to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
France19 sites
Centre Hospitalier du Pays d'Aix
Aix-en-Provence
CHU d'Angers
Angers
CHU de Bordeaux
Bordeaux
CHU Grenoble
Grenoble
Centre Hospitalier Universitaire de Lille
Lille
Hôpital Privé La Louvière
Lille
Hospices Civils de Lyon
Lyon
CHU de Nice
Nice
Hôpital Bichat
Paris
Hôpital Cochin
Paris
Institut Mutualiste Montsouris
Paris
Hôpital privé Francheville
Périgueux
Clinique La Croix du Sud
Quint-Fonsegrives
CHU de Rennes
Rennes
CHU de Rouen
Rouen
Clinique Saint Hilaire
Rouen
Centre Hospitalier Privé Saint Grégoire
Saint-Grégoire
CHU de Toulouse
Toulouse
Clinique Pasteur
Toulouse
Australia2 sites
Epworth Healthcare
Melbourne
Australian Clinical Trials
Wahroonga
About this study
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
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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- REZŪM, alpha blocker and 5-alpha reductase inhibitor
- Keywords
- Prostate, REZŪM, Water vapor thermotherapy, Lower urinary tract symptoms, BPH, LUTS
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REZŪMDevice
Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use.
alpha blocker and 5-alpha reductase inhibitorDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| REZŪM | Active comparator | 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. Receives: Device: REZŪM |
| Dual Drug Therapy | Active comparator | 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. Receives: Drug: alpha blocker and 5-alpha reductase inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From Baseline to 12 months
Secondary outcomes (1)
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
Measured: End of available follow-up, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start15 Sep 2021
- Primary completion11 Dec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Romain Mathieu, Professor, Principal investigator, CHU Rennes, Hôpital PontchaillouEvanguelos Xylinas, Ass. Prof., Principal investigator, Hôpital Bichat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838769
- Sponsor's protocol ID
- U0693
- Acronym
- VAPEUR
- Status last verified
- Oct 2026
- First submitted
- 6 Apr 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No