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

Recruiting now · Not applicable

Conditions studied: Benign Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT06657872

Run by

Assistance Publique Hopitaux De Marseille

People needed

24

Starts

2025-03-24

Expected to finish

2026-11-24

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Service d'urologie, Hôpital Nord (AP-HM) — Marseille, France (enrolling)

Full record on ClinicalTrials.gov

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