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

NCT06657872 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique Hopitaux De Marseille

Phase

Not applicable

Started

2025-03-24

Last updated

2026-02-11

Condition(s) studied

Benign Prostatic Hyperplasia

Investigational drug(s) / intervention(s)

water vapor therapy under general anesthesiawater vapor therapy under local anesthesia

water vapor therapy under general anesthesia: Water vapor procedure will be performe under conscious intravenous sedation with anesthesia team

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).

Study summary

In a pilot study, water vapor therapy (RezumTM, Boston Scientific Corporation, Marlborough, MA) was proposed as a minimally invasive procedure for benign prostatic hyperplasia, but often requiring oral ± intravenous sedation or a transrectal prostatic block. Therefore, pain management during Rezum therapy remains a challenge and may lead to the use of pain control protocols and general anesthesia, limiting in some ways the concept of a minimally invasive ambulatory surgical approach. The Schelin® catheter (ProstaLund AB, Lund, Sweden), approved by the European Medicines Agency, is a device for injecting analgesic drugs directly into the prostate via the trans-urethral route, providing more effective local anesthesia and avoiding the need for transrectal route or general anesthesia. This catheter is therefore of crucial importance in offering to our patients an ultra-minimally invasive treatment, associated with a reduction in room occupancy time, outpatient surgery time, a procedure performed independently of the anesthesia team, and for the patient, an accelerated post-operative recovery. Our hypothesis is that the REZUM procedure under local anesthesia could be associated with a \>20% reduction in operating room occupancy time compared to procedures performed under general anesthesia.

Eligibility

Sex

MALE

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Patients referred for symptomatic benign prostatic hyperplasia (BPH) * Men between 45 and 80 years of age * IPSS \> 13 * Qmax \<15 ml/s * Prostate volume between 30 and 80 g on ultrasound * Patient able to understand study details, benefits and risks * Patient able to give informed consent * Beneficiary of or affiliated to the French social security system * Patient having signed an informed consent form Exclusion Criteria: * Patients with a history of prostate cancer * Patient with history of BPH surgery * Patients with a history of neurological bladder disease * Patient with history of urethral stricture * Patient with history of penile implants * Patient with history of pelvic irradiation * Patient with a symptomatic urinary tract infection in the 10 days prior to surgery * Presence of bladder stones on ultrasonography * Patient allergic to lidocaine 2% or any medication used in the pre-operative protocol (anxiolytics, analgesics and non-steroidal anti-inflammatory drugs) * Patient under guardianship or curatorship * Protected patient, deprived of liberty * Patient with a neurological and/or psychiatric disorder making it impossible to understand the terms of the study and to sign an informed consent form

Primary outcome measure(s)

Comparison of the operating room occupancy time between the 2 groups — Visit 2: surgery
Operating room occupancy time during REZUM procedure

Trial sites (1)

Facility	City	Region	Status
Service d'urologie, Hôpital Nord (AP-HM)	Marseille	France	Recruiting

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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 NCT06657872 on ClinicalTrials.gov ↗ ← All trials in France