Uroial Plus in the Management of Infections and Urinary Symptoms Associated With Ureteral Stents (NCT06251336) | Clinical Trial Compass
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Uroial Plus in the Management of Infections and Urinary Symptoms Associated With Ureteral Stents
78 participantsStarted 2024-03-01
Plain-language summary
Double-blind randomised interventional pilot study. To evaluate whether therapy with UroialTM Plus has a role in rebalancing homeostasis in ureteral stent patients, improving symptoms related to the presence of the ureteral stent in place.
Ureteral stent patients will be randomised into two groups:
* the experimental group will receive UroialTM Plus sachets, one sachet daily at bedtime after urinating, for 30 days
* the control group will receive a placebo, one sachet daily in the evening before going to bed after urinating, for 30 days.
At each visit, the investigator will assess the possible occurrence of urinary symptoms, their severity and their impact on quality of life by administering the following questionnaires: IPSS, USSQ, AIA, SF-36, VAS, EQ-5D-5L.
Who can participate
Age range
18 Years
Sex
ALL
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:
* age \> 18 years
* patients with ureteral stents after endourological treatment for stone disease or abdominal surgery
* ability to sign informed consent
Exclusion Criteria:
* positive urine culture 1 month before enrolment
* recurrent urinary tract infections (3 episodes in the last 12 months, or 2 episodes in the last 6 months)
* previous pelvic radiotherapy
* history of transitional cell carcinoma (TCC)
* history of painful bladder syndrome, actinic cystitis, chronic pelvic pain
* symptomatic benign prostatic hypertrophy under treatment (for males)
* presence of indwelling bladder catheter, suprapubic cystostomy, percutaneous nephrostomy, percutaneous cystostomy, urinary diversion
* pregnancy or lactation
* life expectancy \< 1 year
* patients unable to give or refusing to sign informed consent
* inability to follow protocol procedures
* any condition that the investigator believes may be hazardous to the health of the Patient
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.