Deprescribing dRrugs for Overactive Bladder in General Practice (DROP) (DROP)

Deprescribing dRugs for Overactive Bladder in the Elderly in General Practice - a Randomized Controlled Trial With a Nested Mixed Methods Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overactive Bladder; Deprescribing; PIMS
• Intervention / Treatment: Other: deprescribing-intervention

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg
    • Aalborg, Aalborg, Denmark, 9000
      • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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	Other: deprescribing-intervention; The clinical guideline on "Deprescribing drugs for OAB" in The North Denmark Region serves as the basis for the intervention. The guideline provides recommended procedures for the deprescribing process. The guideline offers procedures for the deprescribing process and includes a deprescribing algorithm and a symptom questionnaire designed to evaluate the impact of medications utilized in the treatment of OAB.; Other Names: DROB (Deprescribing dRugs for Overactive Bladder)
No Intervention: Control group; The primary care clinics in the control group will not contact and evaluate patients and are not informed about the study. Data will be extracted from registries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in proportion of patients receiving drugs for overactive bladder	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.	6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
A qualitative score measuring experiences	Interviews to explore how GPs, staff members, and patients have experienced the intervention and which strategies have been used for the successful deprescribing of drugs for overactive bladder to understand when and how the algorithm is useful using thematic analysis	Approximately 6 months after the study initiates

Collaborators and Investigators

• Sponsor: Anne Estrup Olesen
• Collaborators: University College of Northern Denmark
• Investigators: Principal Investigator: Anne E Olesen, Professor, Aalborg University Hospital

Publications and helpful links

General Publications

• Soerensen AL, Haase Juhl M, Krogh ML, Gronkjaer M, Kristensen JK, Olesen AE. Deprescribing as a Way to Reduce Inappropriate Use of Drugs for Overactive Bladder in Primary Care (DROP): Protocol for a Cluster Randomized Controlled Trial With an Embedded Explanatory Sequential Mixed Methods Study. JMIR Res Protoc. 2024 Jul 23;13:e56277. doi: 10.2196/56277.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Overactive
• Other Study ID Numbers: K2023-012

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