NCT06657872View on ClinicalTrials.gov

Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial

NARecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 24, 2025

Primary Completion Date

July 24, 2026

Study Completion Date

July 24, 2026

Conditions
Benign Prostatic Hyperplasia
Interventions
PROCEDURE

water vapor therapy under general anesthesia

Water vapor procedure will be performe under conscious intravenous sedation with anesthesia team

PROCEDURE

water vapor therapy under local anesthesia

Water vapor procedure will be performe under local anethesia administrated with Schelin® catheter via the trans-urethral route : injection of 20cc of lidocaine 2% intra-prostatically via the schelin catheter at 4 injection points (3cc at 1h, 3cc at 11h, 7cc at 4h, and 7cc at 8h).

Trial Locations (1)

13015

RECRUITING

Service d'urologie, Hôpital Nord (AP-HM), Marseille

All Listed Sponsors
lead

Assistance Publique Hopitaux De Marseille

OTHER