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Group Medical Visits for Latina Women With Urgency Urinary Incontinence

Primary Purpose

Overactive Bladder, Urinary Urgency, Urge Incontinence

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Medical Visits
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overactive Bladder

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients seen in the Urology, Gynecology or Urogynecology clinics at LAC+USC Medical Center, with a diagnosis of OAB, UUI or MUI not undergoing surgical management, who are able to give informed consent.

Exclusion Criteria:

Non-Spanish speaking, pregnant, unwilling or unable to follow protocol, diagnosis of neurogenic bladder or radiation cystitis or presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Sites / Locations

  • LAC-USC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group Medical Visits

Usual Care

Arm Description

Group visits which will provide aspects of support, empowerment, education and medical care.

Usual clinical office visits

Outcomes

Primary Outcome Measures

OABq-SF
Overactive bladder symptom questionnaire

Secondary Outcome Measures

Full Information

First Posted
September 25, 2018
Last Updated
May 31, 2019
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT03687164
Brief Title
Group Medical Visits for Latina Women With Urgency Urinary Incontinence
Official Title
Group Medical Visits for Latina Women With Urgency Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Dropout rate was too high
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a mixed methods study to compare group medical visits (GMVs) to usual care for Spanish speaking Latina women with urgency urinary incontinence. Patients will be randomized to GMVs and to usual care. At the conclusion of each series of GMVs we will hold a focus group for participants.The primary outcome will be improvement in urgency urinary incontinence symptoms.
Detailed Description
Urinary incontinence, though its effects can be personally devastating, exists most often as a quality of life issue. As such, partnering with the patient toward shared medical decision making is of the utmost importance. Research suggests that Latina women with pelvic floor disorders are overwhelmed by the amount and speed of information presented by healthcare providers and respond by placing healthcare decisions within the hands of the provider. Group medical visits have demonstrated improved quality of life, improved healthcare self-efficacy and closed outcomes gaps in low income groups. We propose a mixed methods study to compare group medical visits (GMVs) to usual care for Spanish speaking Latinas presenting to gynecology clinics at LAC+USC. The study will consist of a randomized control trial of GMVs compared to usual care. In addition we will hold focus group for participants of the GMV arm to gain insight into the patient experience of GMVs and how to improve the visits. The primary outcome will be improvement in urgency urinary incontinence symptoms as measured by the OABq SF. Additionally, changes in quality of life and healthcare self-efficacy will be measured before and after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urinary Urgency, Urge Incontinence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Medical Visits
Arm Type
Experimental
Arm Description
Group visits which will provide aspects of support, empowerment, education and medical care.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual clinical office visits
Intervention Type
Other
Intervention Name(s)
Group Medical Visits
Intervention Description
Patients will attend group medical visits in groups of 6 -10. Groups will have a set curriculum and patients will meet with the provider one on one to assess individual needs at each session.
Primary Outcome Measure Information:
Title
OABq-SF
Description
Overactive bladder symptom questionnaire
Time Frame
Four months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients seen in the Urology, Gynecology or Urogynecology clinics at LAC+USC Medical Center, with a diagnosis of OAB, UUI or MUI not undergoing surgical management, who are able to give informed consent. Exclusion Criteria: Non-Spanish speaking, pregnant, unwilling or unable to follow protocol, diagnosis of neurogenic bladder or radiation cystitis or presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine A Volpe, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAC-USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Crossing the Quality Chasm: A New Health System for the 21st Century is report on health care quality in the United States. Institute of Medicine, March 1, 2001.
Results Reference
background
PubMed Identifier
11606875
Citation
Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW Jr, Bandura A, Gonzalez VM, Laurent DD, Holman HR. Chronic disease self-management program: 2-year health status and health care utilization outcomes. Med Care. 2001 Nov;39(11):1217-23. doi: 10.1097/00005650-200111000-00008.
Results Reference
background
PubMed Identifier
23442506
Citation
Sevilla C, Wieslander CK, Alas AN, Dunivan GC, Khan AA, Maliski SL, Rogers RG, Anger JT. Communication between physicians and Spanish-speaking Latin American women with pelvic floor disorders: a cycle of misunderstanding? Female Pelvic Med Reconstr Surg. 2013 Mar-Apr;19(2):90-7. doi: 10.1097/SPV.0b013e318278cc15.
Results Reference
background
PubMed Identifier
18356401
Citation
Gilmer TP, Walker C, Johnson ED, Philis-Tsimikas A, Unutzer J. Improving treatment of depression among Latinos with diabetes using project Dulce and IMPACT. Diabetes Care. 2008 Jul;31(7):1324-6. doi: 10.2337/dc08-0307. Epub 2008 Mar 20.
Results Reference
background
PubMed Identifier
19701691
Citation
Diokno AC, Ocampo MS Jr, Ibrahim IA, Karl CR, Lajiness MJ, Hall SA. Group session teaching of behavioral modification program (BMP) for urinary incontinence: a randomized controlled trial among incontinent women. Int Urol Nephrol. 2010 Jun;42(2):375-81. doi: 10.1007/s11255-009-9626-x. Epub 2009 Aug 22.
Results Reference
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Group Medical Visits for Latina Women With Urgency Urinary Incontinence

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