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

Study Overview
=================
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.

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

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 arms, one with group exercises, one with individual exercises and one with ), Individual exercises guided by ultrasonography imaging
Masking: Double


Arms and Interventions

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