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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Service d'urologie, Hôpital Nord (AP-HM)
RECRUITING
Marseille
Contact Information
Primary
Michael Baboudjian, MD
michael.baboudjian@ap-hm.fr
04.91.96.87.18
Time Frame
Start Date: 2025-03-24
Estimated Completion Date: 2026-07-24
Participants
Target number of participants: 24
Treatments
Active_comparator: general anesthesia
REZUM procedure under general anesthesia
Active_comparator: Local anesthesia
REZUM procedure under local anesthesia
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique Hopitaux De Marseille

This content was sourced from clinicaltrials.gov