Urinary Incontinence in ChildrenPhase 4NCT06465576
Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)
A Phase 4 study testing Solifenacin, Mirabegron and Solifenacin + Mirabegron in people with Urinary Incontinence in Children, run by University of Aarhus at 5 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Urinary Incontinence in Children
- What is being tested?
- Solifenacin, Mirabegron and Solifenacin + Mirabegron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 5 sitesDenmark
- Study dates
- 27 May 2024to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures.
- Age 5 to 14 years (inclusive) at the time of signing the consent and inclusion.
- Diagnose with urinary incontinence as per ICCS criteria.
- Pharmacological treatment with solifenacin and/or mirabegron.
- Continence has been achieved on pharmacological therapy with solifenacin and/or mirabegron.
- Previously withdrawal attempts are accepted.
- Continence remained on the same dosage of medication for a minimum of three months.
Who cannot join
- Inability of the patent(s) or parental custody holder(s) to understand the Danish written and oral information.
- Neurogenic detrusor overactivity (neurogenic bladder)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Department of Pediatric and Adolescent Medicine, Aalborg University Hospital
Aalborg, Aalborg, 9000
Department of Pediatric and Adolescent Medicine, Aarhus University Hospital
Aarhus, Aarhus N, 8200
Department of Pediatric and Adolescent medicine, Esbjerg Hospital
Esbjerg, Esbjerg, 6700
Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
Herning, Herning, 7400
Department of Pediatric and Adolescent Medicine, Kolding Hospital
Kolding, Kolding, 6000
About this study
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.
Read the detailed description
Background and rationale: The pharmacological handling of pediatric incontinence is considered temporary and withdrawal attempts are recommended after continence has been achieved. There is no generally accepted withdrawal strategy for solifenacin and/or mirabegron in children. Currently, two different withdrawal strategies are being employed in the clinical setting, namely abrupt withdrawal, and gradual withdrawal, wherein the dosage of the drug prescribed is reduced or the interval between dosages given is increased. Studies report on the differences in withdrawal strategies of antidiuretic therapy targeted at enuresis in pediatric populations. Several studies have reported on the application of structured withdrawal of desmopressin, indicating that gradual withdrawal of desmopressin therapy results in prolonged intervals of continence without relapse. However, to the best of our knowledge, no studies have investigated the strategy of withdrawal of pharmacological treatment with solifenacin and/or mirabegron in children diagnosed with urinary incontinence that have achieved continence on these pharmaceuticals. Our study is proposed to ensure an evidence-based approach to a withdrawal of strategy for pharmacological treatment with solifenacin and/or mirabegron in children with urinary incontinence.
Objectives: 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. We hypothesize that gradual withdrawal is superior to abrupt withdrawal regarding the risk of recurrence of incontinence.
Study design: This is an open-label prospective randomized trial, allocating participant to each of the three pharmaceutical groups, according to the medical treatment that the child is receiving (solifenacin, mirabegron or solifenacin in combination with mirabegron). Within each pharmaceutical group, the participant will be randomized 1:1 to the intervention being compared; either abrupt withdrawal or gradual withdrawal.
Perspectives:The results are expected to influence the withdrawal strategy of pharmacological treatment with solifenacin and/or mirabegron in children with daytime urinary incontinence.
Ethics: All pharmacological side effects will be handled in accordance with the Danish legislation. No risk or unknown side effects are expected to medical treatment or withdrawal. The therapeutic potential for future patients justifies the project to be carried out. Participation in this study will not lead to any disadvantages for the patient in their treatment. The study will be conducted in accordance with the protocol, applicable regulatory requirements according to Good Clinical Practice and the ethical principles of the Declaration of Helsinki. The study has been approved by the authorities and was initiated in May 2024. Significant additions or changes to the protocol may be conducted after the application for amendment is approved by the Regulatory Authority and the Ethics Committee. Information regarding the participants is protected according to the General Data Protection Regulation and the actual law. The study is registered at the research inventory of the Regions of Denmark (1-16-02-211-24) and at Aarhus University (ARG-2024-731-23833). The study is registered at CTIS (EU CT 2023-510187-13-00).
- Conditions
- Urinary Incontinence in Children
- Being tested
- Solifenacin, Mirabegron, Solifenacin + Mirabegron
- Keywords
- Urinary incontinence, Withdrawal, Children, Solifenacin, Mirabegron
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolifenacinDrug
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.
MirabegronDrug
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.
Solifenacin + MirabegronDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Abrupt withdrawal of solifenacin | Experimental | Not described Receives: Drug: Solifenacin |
| Gradual withdrawal of solifenacin | Experimental | Not described Receives: Drug: Solifenacin |
| Abrupt withdrawal of mirabegron | Experimental | Not described Receives: Drug: Mirabegron |
| Gradual withdrawal of mirabegron | Experimental | Not described Receives: Drug: Mirabegron |
| Abrupt withdrawal of solifenacin + mirabegron | Experimental | Not described Receives: Drug: Solifenacin + Mirabegron |
| Gradual withdrawal of solifenacin + mirabegron | Experimental | Not described Receives: Drug: Solifenacin + Mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of incontinence after withdrawal
Assessed by a 14-day calendar of incontinence episodes
Measured: Baseline and up to 12 months follow-up
Secondary outcomes (1)
Development of any symptoms related to abrupt or gradual withdrawal symptoms
Assessed by a questionnaire on withdrawal symptoms
Measured: Baseline up to 44 days after initiation of withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start27 May 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence in ChildrenStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Within each pharmaceutical group, the participant will be randomized 1:1 to the intervention being compared; either abrupt withdrawal or gradual withdrawal.
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luise Borch, MD, PhD, Study director, Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465576
- Sponsor's protocol ID
- StayDry
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Svendsen AM, Hagstrom S, Kamperis K, Andersen AE, Henneberg NC, Van Batavia J, Olesen AE, Borch L. Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry): Protocol for an Open-Label Prospective Randomized Trial. JMIR Res Protoc. 2025 Jul 9;14:e63226. doi: 10.2196/63226.
PubMed 40633093
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)
- ClinicalTrials.gov ID
- NCT06465576
- Acronym / sponsor ID
- StayDry
- Conditions
- Urinary Incontinence in Children
- Keywords
- Urinary incontinence, Withdrawal, Children, Solifenacin, Mirabegron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and rationale: The pharmacological handling of pediatric incontinence is considered temporary and withdrawal attempts are recommended after continence has been achieved. There is no generally accepted withdrawal strategy for solifenacin and/or mirabegron in children. Currently, two different withdrawal strategies are being employed in the clinical setting, namely abrupt withdrawal, and gradual withdrawal, wherein the dosage of the drug prescribed is reduced or the interval between dosages given is increased. Studies report on the differences in withdrawal strategies of antidiuretic therapy targeted at enuresis in pediatric populations. Several studies have reported on the application of structured withdrawal of desmopressin, indicating that gradual withdrawal of desmopressin therapy results in prolonged intervals of continence without relapse. However, to the best of our knowledge, no studies have investigated the strategy of withdrawal of pharmacological treatment with solifenacin and/or mirabegron in children diagnosed with urinary incontinence that have achieved continence on these pharmaceuticals. Our study is proposed to ensure an evidence-based approach to a withdrawal of strategy for pharmacological treatment with solifenacin and/or mirabegron in children with urinary incontinence.
Objectives: 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. We hypothesize that gradual withdrawal is superior to abrupt withdrawal regarding the risk of recurrence of incontinence.
Study design: This is an open-label prospective randomized trial, allocating participant to each of the three pharmaceutical groups, according to the medical treatment that the child is receiving (solifenacin, mirabegron or solifenacin in combination with mirabegron). Within each pharmaceutical group, the participant will be randomized 1:1 to the intervention being compared; either abrupt withdrawal or gradual withdrawal.
Perspectives:The results are expected to influence the withdrawal strategy of pharmacological treatment with solifenacin and/or mirabegron in children with daytime urinary incontinence.
Ethics: All pharmacological side effects will be handled in accordance with the Danish legislation. No risk or unknown side effects are expected to medical treatment or withdrawal. The therapeutic potential for future patients justifies the project to be carried out. Participation in this study will not lead to any disadvantages for the patient in their treatment. The study will be conducted in accordance with the protocol, applicable regulatory requirements according to Good Clinical Practice and the ethical principles of the Declaration of Helsinki. The study has been approved by the authorities and was initiated in May 2024. Significant additions or changes to the protocol may be conducted after the application for amendment is approved by the Regulatory Authority and the Ethics Committee. Information regarding the participants is protected according to the General Data Protection Regulation and the actual law. The study is registered at the research inventory of the Regions of Denmark (1-16-02-211-24) and at Aarhus University (ARG-2024-731-23833). The study is registered at CTIS (EU CT 2023-510187-13-00).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Within each pharmaceutical group, the participant will be randomized 1:1 to the intervention being compared; either abrupt withdrawal or gradual withdrawal.
| Arm | Type | Receives |
|---|---|---|
| Abrupt withdrawal of solifenacin | Experimental | Drug: Solifenacin |
| Gradual withdrawal of solifenacin | Experimental | Drug: Solifenacin |
| Abrupt withdrawal of mirabegron | Experimental | Drug: Mirabegron |
| Gradual withdrawal of mirabegron | Experimental | Drug: Mirabegron |
| Abrupt withdrawal of solifenacin + mirabegron | Experimental | Drug: Solifenacin + Mirabegron |
| Gradual withdrawal of solifenacin + mirabegron | Experimental | Drug: Solifenacin + Mirabegron |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures.
- Age 5 to 14 years (inclusive) at the time of signing the consent and inclusion.
- Diagnose with urinary incontinence as per ICCS criteria.
- Pharmacological treatment with solifenacin and/or mirabegron.
- Continence has been achieved on pharmacological therapy with solifenacin and/or mirabegron.
Key exclusion criteria (2 listed)
- Inability of the patent(s) or parental custody holder(s) to understand the Danish written and oral information.
- Neurogenic detrusor overactivity (neurogenic bladder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SolifenacinAbrupt 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. | Drug | Abrupt withdrawal of solifenacin, Gradual withdrawal of solifenacin |
| MirabegronAbrupt 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. | Drug | Abrupt withdrawal of mirabegron, Gradual withdrawal of mirabegron |
| Solifenacin + MirabegronAbrupt 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. | Drug | Abrupt withdrawal of solifenacin + mirabegron, Gradual withdrawal of solifenacin + mirabegron |
Primary outcome
Recurrence of incontinence after withdrawal
Time frame: Baseline and up to 12 months follow-up
Assessed by a 14-day calendar of incontinence episodes
1 secondary outcome
Development of any symptoms related to abrupt or gradual withdrawal symptoms
Time frame: Baseline up to 44 days after initiation of withdrawal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 40633093Svendsen AM, Hagstrom S, Kamperis K, Andersen AE, Henneberg NC, Van Batavia J, Olesen AE, Borch L. Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry): Protocol for an Open-Label Prospective Randomized Trial. JMIR Res Protoc. 2025 Jul 9;14:e63226. doi: 10.2196/63226.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luise Borch, MD, PhD study director
Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solifenacin, Mirabegron and Solifenacin + Mirabegron in people with Urinary Incontinence in Children, run by University of Aarhus at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of incontinence after withdrawal (time frame: Baseline and up to 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06465576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.