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

NCT06657872 | Recruiting

• 2 other identifiers: RCAPHM24_02632024-A01800-47
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

REZUM; MIST; general anesthesia; local anesthesia

Outcome Measures

Primary Outcomes (1)

• Comparison of the operating room occupancy time between the 2 groups

  Operating room occupancy time during REZUM procedure

  Visit 2: surgery

Secondary Outcomes (5)

• Comparison of the quality of recovery after surgery between the 2 groups

  24h after surgery

• Comparison of the pain post-surgery between the 2 groups

  1 hour, 2 hours and 24 hours after surgery

• Success rate of the local anesthesia for the REZUM procedure

  intraoperative

• Comparison of functional results between the 2 groups

  3 months post-surgery

• Comparison of the average number of side-effects post-surgery between the 2 groups

  30 days post-surgery

Study Arms (2)

general anesthesia

ACTIVE COMPARATOR

REZUM procedure under general anesthesia

Procedure: water vapor therapy under general anesthesia

Local anesthesia

ACTIVE COMPARATOR

REZUM procedure under local anesthesia

Procedure: water vapor therapy under local anesthesia

Interventions

water vapor therapy under local anesthesia PROCEDURE

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).

Local anesthesia

water vapor therapy under general anesthesia PROCEDURE

Water vapor procedure will be performe under conscious intravenous sedation with anesthesia team

general anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: This study focus on benign prostatic hyperplasia
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Service d'urologie, Hôpital Nord (AP-HM)

Marseille, 13015, France

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Michael Baboudjian, MD

CONTACT

04.91.96.87.18; michael.baboudjian@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 26, 2024
• Study Start: March 24, 2025
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): November 24, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)