Deprescribing DRrugs for Overactive Bladder in General Practice (DROP)

Not Applicable

Recruiting

• Conditions: PIMS; Overactive Bladder; Deprescribing
• Interventions: Other: deprescribing-intervention

• Registration Number: NCT06110975
• Lead Sponsor: Anne Estrup Olesen

Brief Summary

The objective is to understand and evaluate the effectiveness of a deprescribing intervention in primary care, specifically targeting medications for overactive bladder in individuals aged 65 or older.

Detailed Description

Potentially inappropriate medication is prescribed medications with an unfavorable risk-benefit profile, for which there might be better, safer, or more cost-effective alternatives. Anticholinergic drugs for Overactive Bladder (OAB) is an example of a potentially inappropriate medication in the elderly, calling for attention and possible deprescribing. Due to their crucial role in maintaining a patient's medication regimen, primary care settings are widely regarded as the optimal location for conducting medication reviews and deprescribing interventions.

This study utilizes a mixed methods explanatory sequential design, nested in a randomised controlled trial to explore deprescribing drugs for Overactive Bladder (OAB). General practices will be randomized into two groups. The intervention group will then be evaluated in a mixed methods setup and finish the study with a comparison to the control group. The mixed methods approach employs a quantitative approach following the intervention group and investigates the prevalence of deprescribing the drugs in question. Secondly, a qualitative approach will be used to delve into the experiences of general practitioners (GPs), support staff, and patients during the deprescribing process. Finally, the quantitative and qualitative findings are merged to gain a comprehensive understanding of deprescribing for OAB. This integrated approach enhances insights and informs future interventions and recommendations. After the mixed methods studies are completed the control group will be used in an overall comparison of the two groups using registry data

Study Timeline

• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-01
• Study Start: 2023-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• patient must have been prescribed one of the following drugs for OAB within the last 14 months
• patient must be able to speak and understand Danish

Exclusion Criteria

• too cognitively impaired to participate or otherwise unfit to participate as estimated by general practitioner
• receiving neurological or urogenital ambulatory care for their overactive bladder symptoms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	deprescribing-intervention	The primary care clinics in the intervention group will contact and evaluate all patients receiving one or more of the following drugs: G04BD04 Oxybutynin G04BD07 Tolterodine G04BD08 Solifenacin G04BD09 Trospium G04BD10 Darifenacine G04BD11 Fesoterodine G04BD12 Mirabegron The patients will be asked to discontinue the treatment and eventually be deprescribed

Primary Outcome Measures

Name	Time	Method
Difference in proportion of patients receiving drugs for overactive bladder	6 months	The primary outcome will be the difference in the proportion of patients receiving drugs for overactive bladder before and after a 6-month follow-up period.

Secondary Outcome Measures

Name	Time	Method
Changes and distribution of bladder symptoms	6 months	Descriptive characteristics and distribution of bladder symptoms between and within the groups before and after the intervention
The proportion of patients where deprescribing was not initiated	6 months	Descriptive characteristics of the proportion of patients in the intervention group where deprescribing was not initiated.
proportion of patients in the intervention group who had deprescribing initiated but not sustained	6 months	Descriptive characteristics of the proportion of patients in the intervention group who had deprescribing initiated but not sustained.

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark