Back to resultsPilot Study - Patient Education and Pelvic Strength Exercises in Elderly Women With Incontinence.
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Urinary Incontinence
Eligibility Criteria
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
Sites / Locations
- Signe Refsgaard Bech
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Group Training
Individual training
Individual training with biofeedback
Arm Description
Group Training of the women with incontinence - with 5-8 women in each group. This is also Usual Care
Individual pelvic floor exercises one-to-one with the physiotherapist
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.
Outcomes
Primary Outcome Measures
Pelvic floor strength
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.
Pelvic floor strength
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 Outcome Measures
Change in life quality - UDI-6
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
Change in life quality IIQ-7
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
Full Information
NCT ID
NCT03862326
First Posted
February 14, 2019
Last Updated
November 3, 2020
Sponsor
University College of Northern Denmark
Collaborators
Aalborg Municipality
1. Study Identification
Unique Protocol Identification Number
NCT03862326
Brief Title
Pilot Study - Patient Education and Pelvic Strength Exercises in Elderly Women With Incontinence.
Official Title
The Effect of Group-, Individual-, and Ultrasound Guided Pelvic Floor Training on Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College of Northern Denmark
Collaborators
Aalborg Municipality
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 arms, one with group exercises, one with individual exercises and one with ), Individual exercises guided by ultrasonography imaging
Masking
InvestigatorOutcomes Assessor
Masking Description
The Investigator and outcome assessor did not know what treatment the indivdual women got.
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Training
Arm Type
Other
Arm Description
Group Training of the women with incontinence - with 5-8 women in each group. This is also Usual Care
Arm Title
Individual training
Arm Type
Experimental
Arm Description
Individual pelvic floor exercises one-to-one with the physiotherapist
Arm Title
Individual training with biofeedback
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Behaviour
Intervention Description
From lying to sitting to active exercises with focus on the pelvic floor
Primary Outcome Measure Information:
Title
Pelvic floor strength
Description
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.
Time Frame
Change compared to baseline after 12 week intervention
Title
Pelvic floor strength
Description
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.
Time Frame
Change compared to baseline 3 months after end of intervention.
Secondary Outcome Measure Information:
Title
Change in life quality - UDI-6
Description
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
Time Frame
after 12 weeks of exercise and 3 months follow-up
Title
Change in life quality IIQ-7
Description
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
Time Frame
after 12 weeks of exercise and 3 months follow-up
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Signe R Bech, Phd
Organizational Affiliation
University College of Northern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Signe Refsgaard Bech
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study - Patient Education and Pelvic Strength Exercises in Elderly Women With Incontinence.
We'll reach out to this number within 24 hrs