Database for Rezum Water Vapor Therapy for Prostate Issues

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 observational study aims to collect and analyze clinical data on the efficacy, durability, and safety of Rezum water vapor therapy in treating benign prostate obstruction (BPO) and lower urinary tract symptoms (LUTS) in men. The study will involve a large cohort of 1000 patients across multiple centers, with a follow-up period of five years. Rezum therapy involves the injection of steam into the prostate to reduce tissue size and alleviate symptoms. The study will evaluate patient-reported outcomes and uroflowmetry data to assess treatment effectiveness in a real-world setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All male patients who are treated with Rezum due to prostate obstruction and LUTS in the participating study centers can be included if certain inclusion criteria are met and some exclusion criteria are not present.
* The indication to perform Rezum needs to be made independently from the study. The decision for Rezum treatment is the responsibility of each individual practitioner and patient.
* Age ≥ 18 years
* Operated or supervision of surgery by a certified urologist
* Subgroups of special interest are e.g. catheter-dependent patients, patients with oral anticoagulation, patients with preoperative urodynamic pressure-flow investigation (not older than 6 months) or patients with prostates bigger than 80 ml

Exclusion Criteria:

* Missing informed consent
* Lack of ability to answer questionnaires due to laguage problems or mental incapacity (e.g. in dementia, mental disability)
* Patient does not have a personal email address available and the survey cannot be completed via a relative's email address and the patient is not willing to complete the survey on the tablet at the clinic
* Known or suspected neurogenic bladder dysfunction in e.g. Parkinson's disease, multiple sclerosis or other neurological diseases with possible effects on bladder function
* History of malignant bladder tumor in the last two years (including CIS) or currently present malignant bladder tumor at time of Rezum treatment (including CIS)
* Previous operation(s) on the prostate, except prostate biopsy, if this was performed more than 4 weeks ago at time of Rezum treatment
* Previous operation(s) on the bladder neck
* Presence of bladder neck stenosis requiring treatment at time of Rezum treatment
* Planned combination of Rezum treatment concurrently with another urologic (\*) or non-urologic procedure

(\*) also the combination with a planned transurethral procedure is not allowed except for bladder stone removal

Where it's running

• Alexianer St. Hedwig-Krankenhaus
  Berlin, Germany Recruiting
• Universitätsklinikum Frankfurt
  Frankfurt, Germany Recruiting
• Asklepios Westklinikum Hamburg GmbH
  Hamburg, Germany Recruiting
• Urologische Gemeinschaftspraxis Prüner Gang
  Kiel, Germany Recruiting
• Krankenhaus Maria Hilf - Alexianer Krefeld
  Krefeld, Germany Recruiting
• Klinikum Nürnberg
  Nuremberg, Germany Recruiting

Study contacts

• Principal investigator: Felix Wieland, Dr. med. — University Hospital Basel, Department of Urology
• Study coordinator: Niklas Simon, Study Coordinator
• Email: Niklas.Simon@usb.ch
• Phone: +41 615565616

Similar studies

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

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• Comparing bipolar enucleation versus transurethral resection for enlarged prostate outcomes and patient experience

  This trial will test whether bipolar enucleation or standard transurethral resection gives better urinary symptoms, patient experience, and value for men with enlarged prostates who are referred for surgery.

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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.