Local anesthesia for water vapor therapy in treating benign prostatic hyperplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tamsulosin alone vs. tamsulosin with tadalafil for troublesome urinary symptoms from enlarged prostate

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• Tamsulosin With or Without Tadalafil for a Trial Without Catheter After Acute Urinary Retention

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• Tamsulosin dose change or switch to silodosin before catheter removal in men with BPH-related acute urinary retention

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  Recruiting Phase 4 Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07650968

• Water Vapor Therapy vs Ejaculation-Sparing Enucleation for Benign Prostatic Hyperplasia

  This study tests whether Water Vapor Thermal Therapy (Rezum) or an ejaculation-sparing enucleation procedure better helps sexually active men with bothersome BPH symptoms.

  Recruiting Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07648888

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.