Actively Recruiting
Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial
Led by Assistance Publique Hopitaux De Marseille · Updated on 2026-02-11
24
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients referred for symptomatic benign prostatic hyperplasia (BPH)
- Men between 45 and 80 years of age
- IPSS greater than 13
- Maximum urinary flow rate (Qmax) less than 15 ml/s
- Prostate volume between 30 and 80 grams by 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 will not qualify if you...
- History of prostate cancer
- History of BPH surgery
- History of neurological bladder disease
- History of urethral stricture
- History of penile implants
- History of pelvic irradiation
- Symptomatic urinary tract infection in the 10 days prior to surgery
- Presence of bladder stones on ultrasound
- Allergy to lidocaine 2% or medications used in the pre-operative protocol (anxiolytics, analgesics, NSAIDs)
- Patient under guardianship or curatorship
- Protected patient deprived of liberty
- Neurological or psychiatric disorder making it impossible to understand study terms and sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Service d'urologie, Hôpital Nord (AP-HM)
Marseille, France, 13015
Actively Recruiting
Research Team
M
Michael Baboudjian, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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