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NCT Number: NCT06110975

Deprescribing dRrugs for Overactive Bladder in General Practice (DROP)

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

deprescribing-intervention

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.

Other names: DROB (Deprescribing dRugs for Overactive Bladder)

Primary outcomes

  1. Difference in proportion of patients receiving drugs for overactive bladder

    Time frame: 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 outcomes

  1. proportion of patients in the intervention group who had deprescribing initiated but not sustained

    Time frame: 6 months

    Descriptive characteristics of the proportion of patients in the intervention group who had deprescribing initiated but not sustained.

  2. The proportion of patients where deprescribing was not initiated

    Time frame: 6 months

    Descriptive characteristics of the proportion of patients in the intervention group where deprescribing was not initiated.

  3. Changes and distribution of bladder symptoms

    Time frame: 6 months

    Descriptive characteristics and distribution of bladder symptoms between and within the groups before and after the intervention

Other outcomes

  1. A qualitative score measuring experiences

    Time frame: Approximately 6 months after the study initiates

    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

Sponsors and collaborators

Lead sponsor

Anne Estrup Olesen

Other

Collaborators

  • University College of Northern Denmark

Registry information

Official study title

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

Acronym: DROP

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 1, 2023
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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