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Clinical Trials/NCT03687164
NCT03687164
Terminated
N/A

Group Medical Visits for Latina Women With Urgency Urinary Incontinence

University of Southern California1 site in 1 country11 target enrollmentNovember 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Overactive Bladder
Sponsor
University of Southern California
Enrollment
11
Locations
1
Primary Endpoint
OABq-SF
Status
Terminated
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
March 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katherine Volpe

Fellow, Urology

University of Southern California

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.

Outcomes

Primary Outcomes

OABq-SF

Time Frame: Four months

Overactive bladder symptom questionnaire

Study Sites (1)

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