Can a softer stent spare kids from bladder spasms?
NCT ID NCT07742358
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This trial tests whether the design of a ureteral stent—a small tube that drains urine from the kidney to the bladder—affects comfort in children aged 8 to 18 undergoing staged kidney stone treatment. Each participant will receive both a standard Cook stent and a Polaris Ultra stent during two separate procedures, in random order, without knowing which is in place. The study measures bladder spasms, pain, urinary symptoms, and quality of life to see if the Polaris Ultra's softer bladder segment and special coating reduce stent-related discomfort.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Polaris Ultra ureteral stent (a double-J stent with a softer bladder segment and hydrophilic coating) compared to a standard Cook double-J ureteral stent
- What this could lead to
- If the Polaris Ultra stent reduces bladder spasms and discomfort, it could become a preferred choice for children undergoing kidney stone treatment, improving their quality of life during recovery.
- What could go wrong
- This is a small, early-stage crossover trial with only 20 participants, so results may not apply broadly. Stents can still cause symptoms, and individual responses vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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8 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ability of the participant and/or legally authorized representative to provide written informed consent, with assent obtained from the participant when appropriate, in accordance with institutional policy. * Age 8 to 18 years at the time of enrollment. * Undergoing staged ureteroscopic stone management requiring two sequential ureteral stent placements as part of standard clinical care. * Planned placement of unilateral ureteral stents with an anticipated indwelling duration of approximately 4 to 6 weeks per stent. * American Society of Anesthesiologists Physical Status Classification I or II at the time of surgery. * Ability and willingness of the participant and/or caregiver to comply with study procedures, including completion of symptom assessments and questionnaires at specified time points. * Ability to complete study questionnaires in English, either independently or with caregiver assistance. Exclusion Criteria: * American Society of Anesthesiologists Physical Status Classification III or higher at the time of surgery. * Active urinary tract infection, defined as clinical symptoms consistent with infection and a positive urine culture, at the time of screening or before stent placement. * Significant baseline bladder dysfunction, including neurogenic bladder, overactive bladder requiring chronic anticholinergic therapy, or prior bladder augmentation, that could confound assessment of stent-related symptoms. * Requirement for bilateral ureteral stent placement or planned bilateral ureteroscopic procedures. * Known hypersensitivity or allergy to materials used in either ureteral stent included in the study. * Pregnancy or lactation, as determined by clinical assessment and/or institutional testing requirements, where applicable. * Use of chronic opioid therapy, chronic anticholinergic medications, or other medications that, in the investigator's opinion, would substantially interfere with assessment of stent-related pain or urinary symptoms. * Participation in another interventional clinical trial that could interfere with the objectives or outcome assessments of this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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SickKids
RECRUITINGToronto, Ontario, M5G 1E8, Canada
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