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Deprescribing dRrugs for Overactive Bladder in General Practice (DROP)

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06110975
Acronym
DROP
Enrollment
72
Registered
2023-11-01
Start date
2023-12-01
Completion date
2026-12-01
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deprescribing, Overactive Bladder, PIMS

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

Interventions

OTHERdeprescribing-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.

Sponsors

University College of Northern Denmark
CollaboratorOTHER
Anne Estrup Olesen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Primary care clinics are randomized to the deprescribing intervention or control group. The control group is not contacted and comparison relies on register data.

Eligibility

Sex/Gender
ALL
Age
65 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in proportion of patients receiving drugs for overactive bladder6 monthsThe 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

MeasureTime frameDescription
proportion of patients in the intervention group who had deprescribing initiated but not sustained6 monthsDescriptive characteristics of the proportion of patients in the intervention group who had deprescribing initiated but not sustained.
The proportion of patients where deprescribing was not initiated6 monthsDescriptive characteristics of the proportion of patients in the intervention group where deprescribing was not initiated.
Changes and distribution of bladder symptoms6 monthsDescriptive characteristics and distribution of bladder symptoms between and within the groups before and after the intervention

Other

MeasureTime frameDescription
A qualitative score measuring experiencesApproximately 6 months after the study initiatesInterviews 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026