Overactive Bladder Education

Study Overview
=================
Brief Summary
-----------------
Overactive bladder (OAB) is a common, chronic condition, characterized by urinary urgency, with or without urge incontinence, usually with frequency and nocturia. Treatment adherence is a major barrier to management of OAB and drug continuation is poor. Many factors may play a role in non-adherence to medication management of OAB including drug cost, side effects, and a lack of understanding of the disease and treatment process.Studies show that recall of disease information and treatment is often suboptimal. Literature shows that providing written materials is an efficacious way to aid in recall. Based on known poor adherence to OAB medication treatment and the clear role patient education methods have on patient information recall, the investigators believe that improvement of participant education through use of a OAB care plan will improve participant understanding and treatment adherence. Through this randomized trial, the investigators plan to evaluate whether implementation of a OAB Care Plan improves understanding of disease and treatment options, treatment success, and satisfaction. This is a prospective, randomized, controlled study of OAB counseling in new patients presenting to the Urogynecology offices of Hartford Hospital. All new patients with a diagnosis of OAB will be offered participation. All consenting participants will be randomized 1:1 to one of two groups: 1) Standard Care group or 2) Care Plan group. In the Standard Care group, participants will be counseled as the physician routinely counsels patients about OAB, in the Care Plan group, participants will be counseled a printed Overactive Bladder Plan of Care information sheet. At the end of the visit, the participant will complete a Baseline Survey. The Baseline Survey includes basic demographic information, a physician satisfaction survey, and a OAB knowledge survey. The participant will return for follow up as directed by the physician. At the follow up visit, participants in both groups will complete a Followup Survey. The Followup Survey will be completed before the participant sees the physician. The Followup Survey assesses OAB knowledge. Eight months after the baseline visit, each participant's chart will be reviewed for final data collection. If a participant progresses to a treatment method where she is satisfied and would like to remain, this will be documented.

Official Title
-----------------
Overactive Bladder Education

Conditions
-----------------
Urinary Bladder, Overactive, Urinary Incontinence, Urge

Intervention / Treatment
-----------------
* Other: Overactive Bladder Care Plan counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of overactive bladder able and willing to participate and consent age >17 years, <90 years female sex Exclusion Criteria: male sex patients who do not have a diagnosis of overactive bladder age <18 years, >89 years unable or unwilling to participate patients who are already being treated for overactive bladder patients who are planning surgical intervention for pelvic organ prolapse prior to treatment of overactive bladder patients who are planning surgical intervention for stress urinary incontinence prior to treatment of overactive bladder pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care Group<br>In this group, subjects will receive standard counseling regarding Overactive Bladder. | |
| Experimental: Care Plan Group<br>In this group, subjects will receive counseling regarding Overactive Bladder using a printed Overactive Bladder Plan of Care information sheet. | Other: Overactive Bladder Care Plan counseling<br>* Use of a printed Overactive Bladder Plan of Care information sheet.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understanding of Overactive Bladder questionnaire |  | Change from baseline knowledge at follow up visit (on average 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject satisfaction questionnaire |  | Baseline visit (time 0) | 
| Treatment success chart review |  | 8 months after baseline visit |