NCT05495633 SteamOne - Prospective Database for Rezum Water Vapor Therapy of the Prostate
| NCT ID | NCT05495633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Benign Prostate Obstruction (BPO) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-12-16 |
| Primary Completion | 2031-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2022-12-16 with a primary completion date of 2031-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is to assess the clinical data of Rezum (water vapor therapy) in patients with BPO (benign prostate obstruction) and male LUTS (lower urinary tract symptoms) in terms of efficacy, durability and safety in a large, prospective, multi-center cohort consisting of 1000 "real-life" patients with a follow-up of 5 years.
Eligibility Criteria
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
Contact & Investigator
Jan Ebbing, PD Dr. med.
PRINCIPAL INVESTIGATOR
University Hospital Basel, Department of Urology
Frequently Asked Questions
Who can join the NCT05495633 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Benign Prostate Obstruction (BPO). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05495633 currently recruiting?
Yes, NCT05495633 is actively recruiting participants. Contact the research team at Niklas.Simon@usb.ch for enrollment information.
Where is the NCT05495633 trial being conducted?
This trial is being conducted at Graz, Austria, Berlin, Germany, Frankfurt, Germany, Hamburg, Germany and 11 additional locations.
Who is sponsoring the NCT05495633 clinical trial?
NCT05495633 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Jan Ebbing, PD Dr. med. at University Hospital Basel, Department of Urology. The trial plans to enroll 1,000 participants.