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

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to manage pain during a treatment called Rezum, which helps men with benign prostatic hyperplasia (BPH), a condition that causes problems with urination. The trial is testing a special device called the Schelin catheter that allows doctors to deliver pain relief directly to the prostate without the need for general anesthesia or more invasive methods. The goal is to see if using this catheter can shorten the time patients spend in the operating room and help them recover more quickly after the procedure.

To participate in this trial, men between the ages of 45 and 80 who have been diagnosed with BPH and are experiencing specific symptoms may be eligible. They need to be able to understand the details of the study and give their consent to participate. Participants can expect a less invasive experience that could lead to faster recovery times, with the added benefit of not needing to rely on traditional anesthesia methods. This study aims to make treatments for BPH easier and more comfortable for patients.

Gender

MALE

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