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Group Medical Visits for Latina Women With Urgency Urinary Incontinence

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University of Southern California

Status

Terminated

Conditions

Urinary Urgency
Urge Incontinence
Overactive Bladder

Treatments

Other: Group Medical Visits

Study type

Interventional

Funder types

Other

Identifiers

NCT03687164
APP - 18 - 00238

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 2 patient groups

Group Medical Visits
Experimental group
Description:
Group visits which will provide aspects of support, empowerment, education and medical care.
Treatment:
Other: Group Medical Visits
Usual Care
No Intervention group
Description:
Usual clinical office visits

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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