Local anesthesia for water vapor therapy in treating benign prostatic hyperplasia
Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial
This study is testing if using a special catheter for local anesthesia during water vapor therapy can help men with benign prostatic hyperplasia feel less pain and improve their quality of life compared to general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06657872 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Schelin catheter for providing local anesthesia during water vapor therapy (Rezum) for benign prostatic hyperplasia (BPH). The study aims to compare the outcomes of this minimally invasive procedure under local anesthesia versus general anesthesia. By using the Schelin catheter, the trial seeks to enhance pain management and reduce the need for more invasive sedation methods, thereby promoting outpatient treatment. The trial includes men aged 45 to 80 with symptomatic BPH and aims to improve their quality of life through effective symptom relief.
Who should consider this trial
Good fit: Ideal candidates are men aged 45 to 80 with symptomatic benign prostatic hyperplasia and specific urinary flow metrics.
Not a fit: Patients with a history of prostate cancer or previous BPH surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management during BPH treatment, allowing for quicker recovery and outpatient procedures.
How similar studies have performed: Other studies have shown promise with minimally invasive techniques for BPH, but the use of the Schelin catheter in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Marseille
- Service d'urologie, Hôpital Nord (AP-HM) — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Michael Baboudjian, MD
- Email: michael.baboudjian@ap-hm.fr
- Phone: 04.91.96.87.18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.