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

The Effect of Group-, Individual-, and Ultrasound Guided Pelvic Floor Training on Incontinence

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03862326
Enrollment
46
Registered
2019-03-05
Start date
2016-08-01
Completion date
2019-03-01
Last updated
2020-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Brief summary

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

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.

Interventions

BEHAVIORALExercise

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

Sponsors

Aalborg Municipality
CollaboratorOTHER
University College of Northern Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The Investigator and outcome assessor did not know what treatment the indivdual women got.

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pelvic floor strengthChange compared to baseline after 12 week interventionChange in pelvic floor strength measured through internal palpation with the use of oxford Scale (0-5, where 5 is the highest strength) but transferred to percentage and normalized to baseline values.

Secondary

MeasureTime frameDescription
Change in life quality - UDI-6after 12 weeks of exercise and 3 months follow-upUrinary Distress Inventory (UDI-6) questionnaire with a total score, in each of the 6 questions the subjects scores between 0 to 3, 0 being Not at all, 1 being A little bit, 2 being Moderately and 3 being Greatly
Change in life quality IIQ-7after 12 weeks of exercise and 3 months follow-upIncontinence Impact Questionnaire (IIQ-7) questionnaire with a total score, in each of the 7 questions the subjects can score between 0 to 3, 0 being Not at all, 1 being A little bit, 2 being Moderately and 3 being Greatly

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026