Ireland
--:--IST
Active, not recruiting Not applicable

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

NCT04838769 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-09-15
Last updated
2026-10-13

Condition(s) studied

Benign Prostatic Hyperplasia (BPH)

Investigational drug(s) / intervention(s)

REZŪMalpha blocker and 5-alpha reductase inhibitor

REZŪM: Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use.

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.

Study 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.

Eligibility

Sex
MALE
Min age
45 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (21)

FacilityCityRegionStatus
Epworth Healthcare Melbourne Australia
Australian Clinical Trials Wahroonga Australia
Centre Hospitalier du Pays d'Aix Aix-en-Provence France
CHU d'Angers Angers France
CHU de Bordeaux Bordeaux 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
Hôpital Bichat Paris France
Hôpital Cochin Paris France
Institut Mutualiste Montsouris Paris France
Hôpital privé Francheville Périgueux 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 France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04838769 on ClinicalTrials.gov ↗ ← All trials in France