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Pilot Study - Patient Education and Pelvic Strength Exercises in Elderly Women With Incontinence.

NCT ID: NCT03862326

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2019-03-01

Brief Summary

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It will be investigate if women with a diaper grant in Aalborg Municipality can reduce diaper size and thus costs for diapers in the municipality through meetings with a incontinence nurse and pelvic floor exercises.

Detailed Description

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Incontinence is a world wide challenge especially in elderly women. The participation in pelvic floor exercises can to some extent help women with urinary incontinency. In the Municipality of Aalborg in Denmark, the citizens can get a diaper grant, if they are incontinence. The project will be recruiting women with diaper grants and randomly allocate the women to 3 different groups 1) Group training (usual care), 2) Individual training and 3) Individual training with biofeedback in the form of ultrasound. All groups will receive the same incontinence education from the incontinence nurses and physiotherapists. The Women will be offered 6 individual or 10 group base trainings, with increased time between trainings, to increase the participants independency and rely more on home based exercises.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 arms, one with group exercises, one with individual exercises and one with ), Individual exercises guided by ultrasonography imaging
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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Study Groups

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Group Training

Group Training of the women with incontinence - with 5-8 women in each group. This is also Usual Care

Group Type OTHER

Exercise

Intervention Type BEHAVIORAL

From lying to sitting to active exercises with focus on the pelvic floor

Individual training

Individual pelvic floor exercises one-to-one with the physiotherapist

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

From lying to sitting to active exercises with focus on the pelvic floor

Individual training with biofeedback

Individual pelvic floor exercises one-to-one with the physiotherapist but with ultrasound used as biofeedback, and to check if the women are contracting the right muscles.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

From lying to sitting to active exercises with focus on the pelvic floor

Interventions

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Exercise

From lying to sitting to active exercises with focus on the pelvic floor

Intervention Type BEHAVIORAL

Other Intervention Names

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Behaviour

Eligibility Criteria

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Inclusion Criteria

Diaper grant

* Urinary incontinency Living in own home in Aalborg Municipality

Exclusion Criteria

* Dementia Inability to transport herself to the training facility neurological diseases inability to understand Danish or bring a translator
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg Municipality

OTHER

Sponsor Role collaborator

University College of Northern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Signe Refsgaard Bech

Pricipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Signe R Bech, Phd

Role: PRINCIPAL_INVESTIGATOR

University College of Northern Denmark

Locations

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Signe Refsgaard Bech

Aalborg, , Denmark

Site Status

Countries

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Denmark

References

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Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

Reference Type DERIVED
PMID: 39704322 (View on PubMed)

Other Identifiers

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N-20160049

Identifier Type: -

Identifier Source: org_study_id