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Botox doses compared for Kids' bladder control

NCT ID NCT02816151

Disease control Sponsor: CHU de Reims Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at children aged 3 to 15 with overactive bladder caused by nerve problems. It compared two different doses of Botox injections into the bladder muscle to see if a lower dose works just as well as a higher dose. The goal was to improve bladder capacity and reduce pressure, helping children stay dry and protect their kidneys.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

29 people

The number who actually took part.

Start date

Feb 2011

Finished

May 2016

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

3 to 15 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 * Old ≥3 years and ≤15 years * Syndrome of vesical hyperactivity associated with a manometric detrusor hyperactivity * Neurogenic vesico-sphincter disorders * Anticholinergic treatment total/partial Failure/ intolerance * Native Bladder and TB virgin * Bladder patient or ready to be it, or possibly straight bladder * 3 months delay if TB injection in another site * Agreement to stop anticholinergic treatment 1 month before and throughout all protocol non- inclusion criteria * Toxin Botulinic use counter-indication (myasthenia, infantil spinal amyotrophy) * General anaesthesia counter-indication * Haemostasis disorders * Children less than 3 years and more than 16 years * non-neurogenic vesical hyperactivity * Good tolerance and effectiveness of the anticholinergic treatment * Bladder increased or already treated by one or more Toxin injections * Having toxin injection in another site since less than 3 months * Child wouldn't sondered

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Conditions

The condition(s) this trial relates to.

overactive bladder

As listed by the trial registrant

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

Neurogenic vesical hyperactivity syndrom

Contacts and locations

Locations

  • Chu Reims

    France, Reims, 51092, France