Ignite Creation Date:
2024-07-17 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465576
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-13
Brief Title:
Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children StayDry
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children StayDry
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to investigate if abrupt withdrawal versus gradual withdrawal of pharmacotherapy solifenacin andor mirabegron influences the risk of recurrence of incontinence
Children aged 5-14 years diagnosed with urinary incontinence treated with pharmacotherapy of solifenacin andor mirabegron and ready for withdrawal will be randomized 11 to either abrupt or gradual withdrawal according to the medical treatment that the child is receiving
Children aged 5-14 years diagnosed with urinary incontinence treated with pharmacotherapy of solifenacin andor mirabegron and ready for withdrawal will be randomized 11 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 andor 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 andor 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 andor mirabegron in children with urinary incontinence
Objectives The primary objective is to investigate if abrupt withdrawal versus gradual withdrawal of pharmacotherapy solifenacin andor 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 11 to the intervention being compared either abrupt withdrawal or gradual withdrawal
PerspectivesThe results are expected to influence the withdrawal strategy of pharmacological treatment with solifenacin andor 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
Objectives The primary objective is to investigate if abrupt withdrawal versus gradual withdrawal of pharmacotherapy solifenacin andor 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 11 to the intervention being compared either abrupt withdrawal or gradual withdrawal
PerspectivesThe results are expected to influence the withdrawal strategy of pharmacological treatment with solifenacin andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None