NCT04838769 - REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men | Biotech Hunter

Enrollment

154

Participants

Timeline

Start Date

September 15, 2021

Primary Completion Date

February 28, 2026

Study Completion Date

March 31, 2027

Conditions

Benign Prostatic Hyperplasia (BPH)

Interventions

DEVICE

REZŪM

Subjects randomized to receive the REZŪM 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.

Trial Locations (21)

Unknown

Epworth Healthcare, Melbourne

Australian Clinical Trials, Wahroonga

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