Optic

ID

Name

StayDry

Description

The primary objective is to investigate if abrupt withdrawal versus gradual withdrawal of pharmacotherapy (solifenacin and/or mirabegron) influences the risk of recurrence of incontinence. Children aged 5-14 years diagnosed with urinary incontinence, treated with pharmacotherapy of solifenacin and/or mirabegron and ready for withdrawal will be randomized 1:1 to either abrupt or gradual withdrawal, according to the medical treatment that the child is receiving.

Trial arms

Trial start

2024-05-27

Estimated PCD

2027-12-01

Trial end

2027-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Solifenacin

Abrupt withdrawal indicates stopping the medication on the date of withdrawal initiation. Gradual withdrawal involves taking the applied dosage of the medication every other day over a period of 14 days, with the complete cessation of the medication occurring 14 days after the gradual withdrawal process begins.

Arms:

Abrupt withdrawal of solifenacin, Gradual withdrawal of solifenacin

Mirabegron

Abrupt withdrawal indicates stopping the medication on the date of withdrawal initiation. Gradual withdrawal involves taking the applied dosage of the medication every other day over a period of 14 days, with the complete cessation of the medication occurring 14 days after the gradual withdrawal process begins.

Arms:

Abrupt withdrawal of mirabegron, Gradual withdrawal of mirabegron

Solifenacin + Mirabegron

Abrupt withdrawal indicates stopping the medication on the date of withdrawal initiation. Gradual withdrawal involves taking the applied dosage of the medication every other day over a period of 14 days, with the complete cessation of the medication occurring 14 days after the gradual withdrawal process begins.

Arms:

Abrupt withdrawal of solifenacin + mirabegron, Gradual withdrawal of solifenacin + mirabegron

Size

216

Primary endpoint

Recurrence of incontinence after withdrawal

Baseline and up to 12 months follow-up

Eligibility criteria

Inclusion Criteria: 1. The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures. 2. Age 5 to 14 years (inclusive) at the time of signing the consent and inclusion. 3. Diagnose with urinary incontinence as per ICCS criteria. 4. Pharmacological treatment with solifenacin and/or mirabegron. 5. Continence has been achieved on pharmacological therapy with solifenacin and/or mirabegron. 6. Previously withdrawal attempts are accepted. 7. Continence remained on the same dosage of medication for a minimum of three months. Exclusion Criteria: 1. Inability of the patent(s) or parental custody holder(s) to understand the Danish written and oral information. 2. Neurogenic detrusor overactivity (neurogenic bladder)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Within each pharmaceutical group, the participant will be randomized 1:1 to the intervention being compared; either abrupt withdrawal or gradual withdrawal.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 216, 'type': 'ESTIMATED'}}

Updated at

2024-06-19

Organization

Product

Indication

Product

Product

Solifenacin + Mirabegron

Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)