REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Boston Scientific Corporation trials in France
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