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Bladder drug may save kids from second surgery for kidney stones

NCT ID NCT07617896

Symptom relief Sponsor: Beni-Suef University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if a drug called aminophylline, placed directly into the bladder, can help doctors insert a small scope to remove kidney stones in children. About 60 children aged 2 to 17 with a stone in the lower ureter will take part. If the first gentle attempt to pass the scope fails, the child will receive either the drug or a placebo. The goal is to see if the drug makes the second attempt successful, avoiding the need for balloon dilation or a second surgery.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

2 to 18 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Children older than 2 years and younger than 18 years. * Single unilateral lower/distal ureteral stone confirmed by low-dose non-contrast computed tomography according to local policy. * Stone size 5 to 15 mm. * Candidate for definitive treatment by semi-rigid ureteroscopy. * Sterile urine culture before surgery, or previously positive urine culture that has been properly treated before intervention. * Intraoperative failed initial gentle negotiation of the ureteric orifice/intramural ureter according to the study definition. * Written informed consent from the parent or legal guardian, with child assent when appropriate. Exclusion Criteria: * Known hypersensitivity to aminophylline, theophylline, or ethylenediamine. * Use of oral or intravenous aminophylline or theophylline within the previous 24 hours. * Pre-existing ipsilateral JJ ureteral stent. * Stone peeping at the ureteric orifice. * Congenital or acquired abnormality that may affect distal ureteric access, such as ureterocele, obstructive megaureter, distal ureteric stricture, previous ureteric reimplantation, or previous ipsilateral ureteral reconstruction. * Known bladder dysfunction or conditions likely to affect normal bladder capacity. * Multiple ipsilateral ureteral stones or associated renal stones requiring flexible ureteroscopy or a ureteral access sheath strategy. * Febrile urinary tract infection, pyonephrosis, sepsis, or any case requiring urgent decompression instead of definitive ureteroscopy. * Cardiac disease, arrhythmia, uncontrolled hypertension, hyperthyroidism, epilepsy or seizure disorder, or significant hepatic impairment. * Inability to complete follow-up.

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Conditions

The condition(s) this trial relates to.

Ureteral Calculi ureterolithiasis urolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Distal ureteral stone Pediatric urolithiasis Ureteral calculi

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Department of Urology- Beni-Suef University Hospitals

    RECRUITING

    Banī Suwayf, Beni Suweif Governorate, Egypt

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