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Urinary RetentionOPTIONNCT04700969

Onset PrevenTIon of Urinary Retention in Orthopaedic Nursing and Rehabilitation

A study testing : A support program to facilitate implementation of evidence-based practice for postoperative urinary retention in people with Urinary Retention and Hip Fractures, run by Örebro University, Sweden at 17 sites in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Urinary retention (UR) is a common problem in older people undergoing hip surgery. Untreated UR can lead to bladder distention and a permanent damage of the bladder, which can cause both physical and psychical suffering as well as increased costs for society. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Retention, Hip Fractures, Hip Arthritis
What is being tested?
: A support program to facilitate implementation of evidence-based practice for postoperative urinary retention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
17 sitesSweden
Study dates
15 Dec 2020to 30 May 2027
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: Orthopaedic units in Sweden performing hip surgery. -

Exclusion Criteria: Orthopaedic units in Sweden not performing hip surgery

-

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Sweden17 sites

  • Sjukhuset Arvika

    Arvika

  • Danderyds sjukhus

    Danderyd

  • Höglandssjukhuset Eksjö

    Eksjö

  • Enköpings lasarett

    Enköping

  • Mälarsjukhuset

    Eskilstuna

  • Karolinska University Hospital, Huddinge

    Huddinge

  • Capio Ortopediska huset

    Johanneshov

  • Karlskoga Lasarett

    Karlskoga

  • Capio Specialistvård Motala

    Motala

  • Vrinnevisjukhuset

    Norrköping

  • Norrtälje Sjukhus

    Norrtälje

  • Nyköpings lasarett

    Nyköping

  • Örebro University Hospital

    Örebro

  • Södertälje sjukhus

    Södertälje

  • Södersjukhuset

    Stockholm

  • Sjukhuset Torsby

    Torsby

  • Västmanlands sjukhus

    Västerås

Other trials in Sweden

About this study

Official title: Onset PrevenTIon of Urinary Retention in Orthopaedic Nursing and Rehabilitation, OPTION - a Knowledge Implementation Study on a Facilitation Strategy for Multi-professional Clinical Champion Teams

Urinary retention (UR) is a common problem in older people undergoing hip surgery. Untreated UR can lead to bladder distention and a permanent damage of the bladder, which can cause both physical and psychical suffering as well as increased costs for society. Even if national and international practice guidelines are in place for handling UR within the health care system, many fail to comply with them. Compliance to clinical practice guidelines are improved if different professions and managers collaborate as a team. In OPTION (Onset PrevenTIon of urinary retention in Orthopedic Nursing and rehabilitation) the investigators will coach multi-professional local facilitator teams in knowledge translation and implementation of UR practice as well as investigate the effects of such evidence-based practice in orthopedic nursing and rehabilitation.

Implementation of research-based knowledge in evidence-based practice within an organization is complex with several known interacting factors. In a health care system these factors can be the care context, knowledge (innovation) and how the organization facilitates such implementations. The implementation strategy of OPTION utilize established theories of facilitation of knowledge implementation considering evidence and context with focus on leadership. The intervention consists of seminars and systematic support for implementation of UR-guidelines OPTION combine studies of adherence to evidence based practice regarding UR for patients over 65 years old that has undergone hip surgery and the health economic aspects of it. OPTION also contribute with improvements and increased knowledge regarding strategies to implement evidence based health care that can be used in other areas than UR and hip surgeries.

Being tested
: A support program to facilitate implementation of evidence-based practice for postoperative urinary retention
Keywords
Orthopedics, Implementation, Research utilization
Medical subject headings
Urinary Retention, Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • : A support program to facilitate implementation of evidence-based practice for postoperative urinary retentionOther

    A 12-month implementation support program for multi-professional internal facilitator teams

Study groups in NCT04700969
Study groupRoleWhat they receive
A support program to facilitate implementation of EBP for postoperative urinary retentionExperimental12- month support program. Multi-professional facilitator-teams will be supported by a 12-month support program including seminars and monthly supervision (e-discussion forum and group teleconferences) to develop an awareness of, and skills in facilitating implementation of evidence/EBP in clinical everyday care.
Receives: Other: : A support program to facilitate implementation of evidence-based practice for postoperative urinary retention
Control-No support programNo interventionNo support program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to UR guidelines in the care of patients undergoing hip surgery.

    Adherence to national urinary retention guidelines documented in the patients' medical record

    Measured: Change from base line to 1 year after the intervention

Secondary outcomes (7)

  1. Number of hip surgery patients with UR

    Number of hip surgery patients with UR documented in the patients' medical record

    Measured: Change from base line to 1 year after the intervention

  2. Patient participation

    The Patient Preferences for Patient Participation tool (The 4Ps)

    Measured: Change from base line to 1 year after the intervention

  3. Costs related to UR

    Costs for device and labour for bladder scanning and urinary catheterization

    Measured: Change from base line to 1 year after the intervention

  4. The IFs', staff's, and managers' experience of UR care

    Investigated with qualitative interviews

    Measured: Change from base line to 1 year after the intervention

  5. The IFs', staff's, and managers' experience of the facilitation program

    Investigated with qualitative interviews

    Measured: 1 year after the intervention

  6. The experience of people undergoing hip surgery, regarding UR, UR care.

    Investigated with qualitative interviews

    Measured: Change from base line to 1 year after the intervention

  7. The impact of a knowledge translation support program on the peoples' experience of the above

    Investigated with qualitative interviews

    Measured: Change from base line to 1 year after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2021
  2. Study start15 Dec 2020
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04700969
Sponsor's protocol ID
ORU 2020/03330
Acronym
OPTION
Status last verified
Mar 2025
First submitted
23 Dec 2020
Last updated
21 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Halleberg-Nyman M, Fjordkvist E, Joelsson-Alm E, Winberg M, Hommel A, Ostaszkiewicz J, Wallin L, Eldh AC. Implementation of evidence-based practice guidelines to prevent urinary retention in hospitals: A process evaluation in orthopaedic care. PLoS One. 2026 Sep 23;21(9):e0338755. doi: 10.1371/journal.pone.0338755. eCollection 2026.

    PubMed 42776945

  • Winberg M, Fjordkvist E, Joelsson-Alm E, Carlfjord S, Nyman MH, Eldh AC. Contextual Factors Affecting Evidence-Based Practice in Orthopaedic Nursing and Rehabilitation: A Mixed Methods Study. J Adv Nurs. 2026 Apr;82(4):3740-3751. doi: 10.1111/jan.70098. Epub 2025 Jul 19.

    PubMed 40682329

  • Fjordkvist E, Halleberg Nyman M, Winberg M, Joelsson-Alm E, Eldh AC. First-line managers' experience of guideline implementation in orthopaedic nursing and rehabilitation: a qualitative study. BMC Health Serv Res. 2024 Jul 31;24(1):871. doi: 10.1186/s12913-024-11353-w.

    PubMed 39085940

  • Eldh AC, Joelsson-Alm E, Wretenberg P, Halleberg-Nyman M. Onset PrevenTIon of urinary retention in Orthopaedic Nursing and rehabilitation, OPTION-a study protocol for a randomised trial by a multi-professional facilitator team and their first-line managers' implementation strategy. Implement Sci. 2021 Jun 26;16(1):65. doi: 10.1186/s13012-021-01135-x.

    PubMed 34174917

Questions about this trial

What is this clinical trial studying?

A study testing : A support program to facilitate implementation of evidence-based practice for postoperative urinary retention in people with Urinary Retention and Hip Fractures, run by Örebro University, Sweden at 17 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Sweden. 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?

Adherence to UR guidelines in the care of patients undergoing hip surgery. (time frame: Change from base line to 1 year after the intervention). 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 NCT04700969, which also lists 4 linked publications.

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 21 Mar 2025.

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