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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Behavioral: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Signe Refsgaard Bech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group Training; Group Training of the women with incontinence - with 5-8 women in each group. This is also Usual Care	Behavioral: Exercise; From lying to sitting to active exercises with focus on the pelvic floor; Other Names: Behaviour
Experimental: Individual training; Individual pelvic floor exercises one-to-one with the physiotherapist	Behavioral: Exercise; From lying to sitting to active exercises with focus on the pelvic floor; Other Names: Behaviour
Experimental: 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.	Behavioral: Exercise; From lying to sitting to active exercises with focus on the pelvic floor; Other Names: Behaviour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University College of Northern Denmark
• Collaborators: Aalborg Municipality
• Investigators: Principal Investigator: Signe R Bech, Phd, University College of Northern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence
• Other Study ID Numbers: N-20160049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No