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OpenTrials
Completed

NCT Number: NCT03862326

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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Signe Refsgaard Bech

Aalborg, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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

Other names: Behaviour

Primary outcomes

  1. Pelvic floor strength

    Time frame: Change compared to baseline after 12 week intervention

    Change 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.

  2. Pelvic floor strength

    Time frame: Change compared to baseline 3 months after end of intervention.

    Change 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 outcomes

  1. Change in life quality - UDI-6

    Time frame: after 12 weeks of exercise and 3 months follow-up

    Urinary 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

  2. Change in life quality IIQ-7

    Time frame: after 12 weeks of exercise and 3 months follow-up

    Incontinence 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

Sponsors and collaborators

Lead sponsor

University College of Northern Denmark

Other

Collaborators

  • Aalborg Municipality

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2019
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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