Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial
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 cha
| Condition(s) | Benign Prostatic Hyperplasia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 ca |
| Who can participate | 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 |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
| Locations | Marseille, France |
| Start date | 2025-03-24 |
| NCT ID | NCT06657872 |
| Official listing | https://clinicaltrials.gov/study/NCT06657872 |