Overactive Bladder Education

Urinary Bladder, Overactive Clinical Trial

Official title:

Overactive Bladder Education

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02505607
• Other study ID #: HHC-2015-0109
• Status: Terminated
• Phase: N/A
• First received: July 20, 2015
• Last updated: December 29, 2015
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Other:
• Overactive Bladder Care Plan counseling
Use of a printed "Overactive Bladder Plan of Care" information sheet.

Locations

Country	Name	City	State
United States	Hartford Hospital, Urogynecology Division	Glastonbury	Connecticut
United States	Hartford Hospital, Urogynecology Division	Hartford	Connecticut
United States	Hartford Hospital, Urogynecology Division	West Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. Review. — View Citation

D'Souza AO, Smith MJ, Miller LA, Doyle J, Ariely R. Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan. J Manag Care Pharm. 2008 Apr;14(3):291-301. — View Citation

Pickney CS, Arnason JA. Correlation between patient recall of bone densitometry results and subsequent treatment adherence. Osteoporos Int. 2005 Sep;16(9):1156-60. Epub 2005 Mar 3. — View Citation

Watson PW, McKinstry B. A systematic review of interventions to improve recall of medical advice in healthcare consultations. J R Soc Med. 2009 Jun;102(6):235-43. doi: 10.1258/jrsm.2009.090013. Review. — View Citation

Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009 Nov-Dec;15(9):728-40. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understanding of Overactive Bladder questionnaire		Change from baseline knowledge at follow up visit (on average 8 weeks)	No
Secondary	Subject satisfaction questionnaire		Baseline visit (time 0)	No
Secondary	Treatment success chart review		8 months after baseline visit	No