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

Recruiting N/A Interventional Study
Benign Prostatic Hyperplasia
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Male
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Assistance Publique Hopitaux De Marseille · Other
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About This 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 challenge and may lead to the use of pain control protocols and general anesthesia,…
Trial Locations
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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 inf…
Contacts

Michael Baboudjian, MD

04.91.96.87.18

michael.baboudjian@ap-hm.fr

CONTACT