CompletedNot Applicable

Effectiveness of Drainage by PCN vs. JJ in Patients With Symptoms of Obstructive Kidney Disease Caused by Urolithiasis

Netherlands204 participantsStarted 2020-07-15

Plain-language summary

To investigate the effectiveness of percutaneous nephrostomy catheter placement versus retrograde double J catheter placement in patients with symptoms of obstructive kidney disease (with either infection and/or pain and/or kidney function deterioration) caused by urolithiasis.

Who can participate

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: \- In order to be considered eligible to participate in this study, a subject must meet all of the following criteria: * Male/female \>18 year * Symptoms and/or laboratory results indicating obstructive kidney disease with or without infection. * A kidney or ureteral stone is present on ultrasound or CT (max 3 months old prior to presentation) * Both drainage techniques are feasible and safe in opinion of the treating physician (from logistics point of view and in the best interest of the patient). * Willing and able to comply with filling in questionnaires and follow-up regiment Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Analphabetic or not mastering the Dutch language * Pregnancy * Usage of anticoagulation agents other than acetylsalicylic acid. * Contraindication for either technique looking at history and anatomy (e.g. kidney transplant, pouch, Bricker deviation, urethral or ureteral stenosis)

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

time (hours) to clinical recovery regarding infection

Timeframe: 3 months

time (hours) to clinical recovery regarding infection

Timeframe: 3 months

time (hours) to clinical recovery regarding pain

Timeframe: 3 months

time (in hours) to clinical recovery regarding kidney function

Timeframe: 3 months

Trial details

NCT IDNCT04594161

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-01

View on ClinicalTrials.gov More Urolithiasis trials

Who can participate

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.