NCT06657872 Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial

Eligibility & Interventions

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You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 24 participants in total. It began in 2025-03-24 with a primary completion date of 2026-11-24.

Brief 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 Criteria

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

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