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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04838769




Registration number
NCT04838769
Ethics application status
Date submitted
6/04/2021
Date registered
9/04/2021

Titles & IDs
Public title
REZUM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men
Scientific 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
Secondary ID [1] 0 0
U0693
Universal Trial Number (UTN)
Trial acronym
VAPEUR RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia (BPH) 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - REZUM
Treatment: Drugs - alpha blocker and 5-alpha reductase inhibitor

Active comparator: REZUM - Subjects randomized to receive the REZUM treatment will receive standardized treatment, following the Instruction for Use (IFU). The REZUM 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 REZUM 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.

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.


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

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
International Prostate Symptom Score (IPSS) change
Timepoint [1] 0 0
From Baseline to 12 months
Primary outcome [2] 0 0
Male Sexual Health Questionnaire (MSHQ) total score change
Timepoint [2] 0 0
From Baseline to 12 months
Secondary outcome [1] 0 0
Disease Progression
Timepoint [1] 0 0
End of available follow-up, up to 24 months

Eligibility
Key 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
Minimum age
45 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Epworth Healthcare - Melbourne
Recruitment hospital [2] 0 0
Australian Clinical Trials - Wahroonga
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Wahroonga
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Aix-en-Provence
Country [2] 0 0
France
State/province [2] 0 0
Angers
Country [3] 0 0
France
State/province [3] 0 0
Bordeaux
Country [4] 0 0
France
State/province [4] 0 0
Créteil
Country [5] 0 0
France
State/province [5] 0 0
Grenoble
Country [6] 0 0
France
State/province [6] 0 0
Lille
Country [7] 0 0
France
State/province [7] 0 0
Lyon
Country [8] 0 0
France
State/province [8] 0 0
Nice
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
Perigueux
Country [11] 0 0
France
State/province [11] 0 0
Quint-Fonsegrives
Country [12] 0 0
France
State/province [12] 0 0
Rennes
Country [13] 0 0
France
State/province [13] 0 0
Rouen
Country [14] 0 0
France
State/province [14] 0 0
Saint-Grégoire
Country [15] 0 0
France
State/province [15] 0 0
Toulouse

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Romain Mathieu, Professor
Address 0 0
CHU Rennes, Hôpital Pontchaillou
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Caroline Beaudoint
Address 0 0
Country 0 0
Phone 0 0
+32479904163
Fax 0 0
Email 0 0
Caroline.Beaudoint@bsci.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04838769