NCT03687164

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

June 4, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

September 25, 2018

Last Update Submit

May 31, 2019

Conditions

Overactive BladderUrinary UrgencyUrge Incontinence

Outcome Measures

Primary Outcomes (1)

  • OABq-SF

    Overactive bladder symptom questionnaire

    Four months

Study Arms (2)

Group Medical Visits

EXPERIMENTAL

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

Other: Group Medical Visits

Usual Care

NO INTERVENTION

Usual clinical office visits

Interventions

Group Medical VisitsOTHER

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.

Group Medical Visits

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAC-USC

Los Angeles, California, 90033, United States

Location

Related Publications (5)

  • 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.

    BACKGROUND

  • 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.

    PMID: 11606875BACKGROUND

  • 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.

    PMID: 23442506BACKGROUND

  • 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.

    PMID: 18356401BACKGROUND

  • 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.

    PMID: 19701691BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination Disorders

Study Officials

  • Katherine A Volpe, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow, Urology

Study Record Dates

First Submitted

September 25, 2018

First Posted

September 27, 2018

Study Start

November 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

June 4, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)