Intermittent Catheterization Versus Trial Without Catheter (NCT05094947) | Clinical Trial Compass
UnknownNot Applicable
Intermittent Catheterization Versus Trial Without Catheter
Russia200 participantsStarted 2021-08-03
Plain-language summary
This is a prospective, comparative, multicenter, randomized controlled trial. The aim of this study is to compare the efficacy, safety and quality of life within patients with acute urinary retention managed by the intermittent catheterization compared or indwelling Foley catheter.
Who can participate
Age range
21 Years – 95 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Men with acute urinary retention due to prostatic hyperplasia
Exclusion Criteria:
* Patient's with serious conditions and incapacity
* Previous urethral or prostate surgery.
* Urethral stricture.
* Urethrorrhagia.
* Injuries of urethra and perineum.
* Attempts of bladder catheterization within 15 days before the acute urinary retention episode.
* Urinary tract infection.
* Neurogenic bladder.
* Chronic urinary retention with a bladder volume of more than 1 liter.
* Obstructive uropathy due to the acute urinary retention.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of the quality of life
Timeframe: 2 months
Trial details
NCT IDNCT05094947
SponsorMoscow State University of Medicine and Dentistry