SteamOne - Prospective Registry Database for Rezum water vapor therapy of the prostate - SteamOne

Klinik für Urologie, Universitätsspital Basel0 个研究点目标入组 1,000 人开始时间: 2022年8月5日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•* 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

•* Missing informed consent
•* Lack of ability to answer questionnaires in German language or mentally by oneself (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 (a) or non-urologic procedure
•(a) also the combination with a planned transurethral procedure is not allowed except for bladder stone removal

发起方

Klinik für Urologie, Universitätsspital Basel