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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862326
• Other study ID #: N-20160049
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: March 1, 2019

Study information

• Verified date: November 2020
• Source: University College of Northern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Behavioral:
• Exercise
From lying to sitting to active exercises with focus on the pelvic floor

Locations

Country	Name	City	State
Denmark	Signe Refsgaard Bech	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
University College of Northern Denmark	Aalborg Municipality

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change compared to baseline after 12 week intervention
Primary	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.	Change compared to baseline 3 months after end of intervention.
Secondary	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	after 12 weeks of exercise and 3 months follow-up
Secondary	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	after 12 weeks of exercise and 3 months follow-up