Clinical trial NCT03687164: 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
Overall status: TERMINATED
Phase: NA
Conditions: Overactive Bladder
Urinary Urgency
Urge Incontinence
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: OABq-SF
timeFrame: Four months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LAC-USC
state: California
Study officials:
affiliation: University of Southern California
name: Katherine A Volpe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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