Overactive BladderDROPNCT06110975
Deprescribing dRrugs for Overactive Bladder in General Practice (DROP)
A study testing deprescribing-intervention in people with Overactive Bladder and Deprescribing, run by Anne Estrup Olesen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Overactive Bladder, Deprescribing, PIMS
- What is being tested?
- deprescribing-intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- deprescribing-intervention
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deprescribing-interventionOther
Also called DROB (Deprescribing dRugs for Overactive Bladder)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anne Estrup Olesen
- Sponsor type
- University, hospital or other
- Collaborators
- University College of Northern Denmark
- Responsible party
- Sponsor-investigator, Anne Estrup Olesen, Aalborg University Hospital
- Investigators
- Anne E Olesen, Professor, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110975
- Sponsor's protocol ID
- K2023-012
- Acronym
- DROP
- Status last verified
- Nov 2025
- First submitted
- 5 Oct 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39042875
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deprescribing dRugs for Overactive Bladder in the Elderly in General Practice - a Randomized Controlled Trial With a Nested Mixed Methods Study
- ClinicalTrials.gov ID
- NCT06110975
- Acronym / sponsor ID
- DROP / K2023-012
- Conditions
- Overactive Bladder, Deprescribing, PIMS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Anne Estrup OlesenUniversity, hospital or other
- Collaborators
- University College of Northern Denmark
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: deprescribing-interventionThe 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 |
| 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 |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deprescribing-interventionAlso: DROB (Deprescribing dRugs for Overactive Bladder)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 | Intervention group |
Primary outcome
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.
3 secondary outcomes
proportion of patients in the intervention group who had deprescribing initiated but not sustained
Time frame: 6 months
The proportion of patients where deprescribing was not initiated
Time frame: 6 months
Changes and distribution of bladder symptoms
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Derived from this study: PubMed 39042875Soerensen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne E Olesen, Professor principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deprescribing-intervention in people with Overactive Bladder and Deprescribing, run by Anne Estrup Olesen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in proportion of patients receiving drugs for overactive bladder (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06110975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.