Prevent Inability To Control Urination

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the capacity of self-efficacy to predict maintaining a behavior change at four years post urinary control intervention.

Detailed Description
-----------------
This is a study that will monitor and compare attitudes and strategies that women use to maintain behavior changes that prevent urination problems. Women will complete questionnaires, do muscle strength exercises, and bladder training at 3 months, one year, and 4 years post intervention.

Official Title
-----------------
Promoting Self -Care to Prevent Urinary Incontinence

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

Intervention / Treatment
-----------------
* Behavioral: Bladder Health Class


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion and exclusion criteria Female 55 through 80 years old Post-menopausal-no menstrual cycle for the past 12 months except for women who are on hormone replacement therapy. Continent of urine (using the MESA definition of continence) defined as: No previous incontinence episode except during pregnancy and/or postpartum period. Urine loss less than 6 days during the last 365 days No previous or present incontinence treatment with pharmacological agents, behavioral programs or surgical therapy. No history of bladder cancer, stroke, multiple sclerosis, parkinsonism, epilepsy, spinal cord tumor or trauma. No reported difficulty with activities of daily living, i.e. walking about the house, dressing, getting in/out of bed, getting to/using the toilet, bathing/showering, or eating. Additional criteria are applied at a physical examination: Mini Mental Status of at least 24 Negative for objective urine loss during coughing.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1 Bladder Health Class<br>A two-hour bladder health class presented by two experts in urinary incontinence and followed by an individual follow-up teaching session with an incontinence nurse specialist. | Behavioral: Bladder Health Class<br>* A two-hour bladder health class presented by two experts in urinary incontinence and followed by an individual follow-up teaching session with an incontinence nurse specialist.<br>|
| No Intervention: 2 Control Group<br>Participants randomized to this arm did not receive any interventions. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of incontinence episodes |  | Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscle strength |  | Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline | 
| Length of voiding interval |  | Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline | 
| Self-efficacy |  | Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Self Care, Behavior Modification