Overactive BladderNCT03687164
Group Medical Visits for Latina Women With Urgency Urinary Incontinence
A study testing Group Medical Visits in people with Overactive Bladder and Urinary Urgency, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Overactive Bladder, Urinary Urgency, Urge Incontinence
- What is being tested?
- Group Medical Visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Overactive Bladder, Urinary Urgency, Urge Incontinence
- Being tested
- Group Medical Visits
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Medical Visits | Experimental | Group visits which will provide aspects of support, empowerment, education and medical care. Receives: Other: Group Medical Visits |
| Usual Care | No intervention | Usual clinical office visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
OABq-SF
Overactive bladder symptom questionnaire
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Nov 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Why it stopped: Dropout rate was too high
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Volpe, University of Southern California
- Investigators
- Katherine A Volpe, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687164
- Sponsor's protocol ID
- APP - 18 - 00238
- Status last verified
- May 2019
- First submitted
- 25 Sep 2018
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 11606875Sevilla 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.
PubMed 23442506Gilmer 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.
PubMed 18356401Diokno 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.
PubMed 19701691
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Medical Visits for Latina Women With Urgency Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03687164
- Acronym / sponsor ID
- APP - 18 - 00238
- Conditions
- Overactive Bladder, Urinary Urgency, Urge Incontinence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dropout rate was too high
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Medical Visits | Experimental | Other: Group Medical VisitsGroup visits which will provide aspects of support, empowerment, education and medical care. |
| Usual Care | No intervention | –Usual clinical office visits |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Medical VisitsPatients 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. | Other | Group Medical Visits |
Primary outcome
OABq-SF
Time frame: Four months
Overactive bladder symptom questionnaire
Results and safety
The study was stopped early (reason given: Dropout rate was too high). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- BackgroundCrossing 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: PubMed 11606875Lorig 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.
- Background: PubMed 23442506Sevilla 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.
- Background: PubMed 18356401Gilmer 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.
- Background: PubMed 19701691Diokno 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine A Volpe, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Medical Visits in people with Overactive Bladder and Urinary Urgency, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Dropout rate was too high). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OABq-SF (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03687164, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.