Deprescribing dRrugs for Overactive Bladder in General Practice (DROP)

NCT06110975 | Active Not Recruiting

• 1 other identifier: K2023-012
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Deprescribing; PIMS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  6 months

• Changes and distribution of bladder symptoms

  6 months

Other Outcomes (1)

• A qualitative score measuring experiences

  Approximately 6 months after the study initiates

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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.

Also known as: DROB (Deprescribing dRugs for Overactive Bladder)

Intervention group

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anne Estrup Olesen: lead
• University College of Northern Denmark: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, Aalborg, 9000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 39042875 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne E Olesen, Professor

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: November 1, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)