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.
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