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

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence in Children
• Intervention / Treatment: Drug: Solifenacin; Drug: Mirabegron; Drug: Solifenacin + Mirabegron

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 Type: Interventional
• Enrollment (Estimated): 216
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Luise Borch, MD, PhD; Phone Number: +45 78433654; Email: luise.borch@rm.dk
• Study Contact Backup: Name: Ann-Kristine Mandøe Svendsen, MD; Phone Number: +45 78430408; Email: ankrso@rm.dk

Study Locations

• Denmark
  • Aalborg
    • Aalborg, Aalborg, Denmark, 9000
      • Recruiting
      • Department of Pediatric and Adolescent Medicine, Aalborg University Hospital
      • Contact: Søren Hagstrøm, Professor; Phone Number: +45 97663374; Email: soha@rm.dk
  • Aarhus N
    • Aarhus, Aarhus N, Denmark, 8200
      • Recruiting
      • Department of Pediatric and Adolescent Medicine, Aarhus University Hospital
      • Contact: Konstantinos Kamperis, MD, PhD; Email: konskamp@rm.dk
      • Sub-Investigator: Ann-Kristine Mandøe Svendsen, MD
  • Esbjerg
    • Esbjerg, Esbjerg, Denmark, 6700
      • Not yet recruiting
      • Department of Pediatric and Adolescent medicine, Esbjerg Hospital
      • Contact: Linda Kuhne-Qvist, MD; Email: Linda.Kuhne-qvist2@rsyd.dk
  • Herning
    • Herning, Herning, Denmark, 7400
      • Recruiting
      • Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
      • Contact: Luise Borch, MD, PhD; Phone Number: +45 78433654; Email: luise.borch@rm.dk
      • Principal Investigator: Ann-Kristine Mandøe Svendsen, MD
  • Kolding
    • Kolding, Kolding, Denmark, 6000
      • Not yet recruiting
      • Department of Pediatric and Adolescent Medicine, Kolding Hospital
      • Contact: Louise Winding, MD; Email: louise.winding1@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abrupt withdrawal of solifenacin	Drug: 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.
Experimental: Gradual withdrawal of solifenacin	Drug: 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.
Experimental: Abrupt withdrawal of mirabegron	Drug: 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.
Experimental: Gradual withdrawal of mirabegron	Drug: 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.
Experimental: Abrupt withdrawal of solifenacin + mirabegron	Drug: 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.
Experimental: Gradual withdrawal of solifenacin + mirabegron	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of incontinence after withdrawal	Assessed by a 14-day calendar of incontinence episodes	Baseline and up to 12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of any symptoms related to abrupt or gradual withdrawal symptoms	Assessed by a questionnaire on withdrawal symptoms	Baseline up to 44 days after initiation of withdrawal

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Director: Luise Borch, MD, PhD, Department of Pediatric and Adolescent Medicine, Gødstrup Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Children; Urinary incontinence; Mirabegron; Withdrawal; Solifenacin
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, Bridged-Ring; Tetrahydroisoquinolines; Isoquinolines; Quinuclidines; Solifenacin Succinate; mirabegron
• Other Study ID Numbers: StayDry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No