Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT05495633
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05495633
Study Brief:
Protocol Section:
NCT05495633