Deprescribing dRrugs for Overactive Bladder in General Practice (DROP)

NCT ID: NCT06110975

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-12-01

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

Conditions

Overactive Bladder; Deprescribing; PIMS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

deprescribing-intervention

Intervention Type: OTHER

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

DROB (Deprescribing dRugs for Overactive Bladder)

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College of Northern Denmark

OTHER

Sponsor Role: collaborator

Anne Estrup Olesen

OTHER

Sponsor Role: lead

Responsible Party

Anne Estrup Olesen

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anne E Olesen, Professor

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

Aalborg University Hospital

Aalborg, Aalborg, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 39042875 (View on PubMed)

Other Identifiers

K2023-012

Identifier Type: -

Identifier Source: org_study_id