Overactive Bladder Education

Sponsor
Hartford Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT02505607
Collaborator
(none)
22
3
2
5
7.3
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Overactive Bladder Care Plan counseling
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Overactive Bladder Education
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard Care Group

In this group, subjects will receive standard counseling regarding Overactive Bladder.

Experimental: Care Plan Group

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
Use of a printed "Overactive Bladder Plan of Care" information sheet.

Outcome Measures

Primary Outcome Measures

  1. Understanding of Overactive Bladder questionnaire [Change from baseline knowledge at follow up visit (on average 8 weeks)]

Secondary Outcome Measures

  1. Subject satisfaction questionnaire [Baseline visit (time 0)]

  2. Treatment success chart review [8 months after baseline visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 89 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hartford Hospital, Urogynecology Division Glastonbury Connecticut United States
2 Hartford Hospital, Urogynecology Division Hartford Connecticut United States 06106
3 Hartford Hospital, Urogynecology Division West Hartford Connecticut United States

Sponsors and Collaborators

  • Hartford Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Katie Propst, Fellow, Hartford Hospital
ClinicalTrials.gov Identifier:
NCT02505607
Other Study ID Numbers:
  • HHC-2015-0109
First Posted:
Jul 22, 2015
Last Update Posted:
Dec 31, 2015
Last Verified:
Dec 1, 2015

Study Results

No Results Posted as of Dec 31, 2015