Urinary IncontinenceOUTPACENCT06040645
Outcomes of Urinary Incontinence Treatment in Primary Care: APP Co-Management and Electronic Consult
A study testing APP Co-management and E-consult in people with Urinary Incontinence, run by University of California, San Diego at 3 sites in United States.
Trial summary
The burden of urinary incontinence (UI) on American women is immense in both human and financial terms, and continues to rise with the aging US population. Although numerous non-surgical management strategies have proven efficacy for both stress and urge urinary incontinence, there remains a lack of appropriate UI… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- APP Co-management and E-consult
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Feb 2024to 8 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary care physician belonging to a recruited office among one of three participating sites: UCSD, UCLA, KUMC
- Age \>18 y/o
- English or Spanish fluency
- Female
- Answers \"yes\" to incontinence screening tool and agrees to participate
Who cannot join
- Non-primary care specialty
- Does not belong to one of the participating offices
- Age \<18 y/o
- Answers \"no\" to incontinence screening tool and/or does not agree to participate
- Primary care provider (who reviews a list of patients that screen positive) deems patient ineligible due to pregnant, severe memory impairment, or psychiatric history preventing participation
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Kansas
Lawrence, Kansas, 66045
University of California Los Angeles
Los Angeles, California, 90095
University of California San Diego
San Diego, California, 92093
About this study
The burden of urinary incontinence (UI) on American women is immense in both human and financial terms, and continues to rise with the aging US population. Although numerous non-surgical management strategies have proven efficacy for both stress and urge urinary incontinence, there remains a lack of appropriate UI management in the primary care setting. The goal of this multi-site cluster randomized comparative effectiveness trial is to compare the effects of two methods of nonsurgical UI care delivery - electronic consult vs. advanced practice provider (APP) co-management. These two evidence-based, practice-changing strategies are designed to improve the quality of care for an ethnically diverse population of women with UI, and, by reducing deficits in care, obtain better patient-reported outcomes. Both arms of the study will include basic physician education (academic detailing) and electronic clinical decision support. In Arm 1, the investigators will implement an electronic referral system (electronic referral), in which specialists will electronically review referrals and make additional recommendations if appropriate primary UI care was not provided. In Arm 2, Advanced Practice Provider (APP) co-management will reduce the burden of care on the PCPs by providing UI care, patient education, and assisting with patient self-management through dedicated televisits (APP co-management).
Read the detailed description
The Burden of Urinary Incontinence on American Women is Immense: Although a great deal of research on quality of care has been conducted in many areas of medicine and surgery, there remains a relative paucity of data regarding the quality of care for women with urinary incontinence (UI). UI is defined by the International Continence Society as the complaint of any involuntary leakage of urine. The burden of UI on American women is immense in both human and financial terms, and continues to rise with the aging population. According to the National Health and Nutrition Examination Survey, the prevalence of UI among women ranges from 38%-53%. The lifetime risk of undergoing surgery for UI or pelvic organ prolapse is 20%. With the aging of the baby boomers it is projected that the number of women with UI will increase by 55% by 2050. UI negatively impacts health-related quality of life and is associated with embarrassment, stigma, and social isolation.
Primary Care Interventions for UI are Needed. In prior research by our team to provide background for the current proposal, the investigators sought to qualitatively assess challenges and barriers that primary care providers (PCPs) experience in caring for patients with UI. Twelve providers from the specialties of family medicine, general internal medicine, and geriatrics were interviewed. Providers described a lack of understanding of important components of a pelvic exam. Some male providers mentioned their own discomfort performing a pelvic exam on women. PCPs also discussed uncertainty in reaching a correct UI diagnosis (stress urinary incontinence, SUI, vs. urge urinary incontinence, UUI). There were also concerns about anticholinergic drug interactions and their association with cognitive impairment. There was a general lack of familiarity with medication options and dosing and a lack of knowledge about logistics in referring to pelvic floor physical therapy. Providers mentioned the need for an algorithm for the treatment of UI. They also described systems barriers included competing priorities with other medical issues, time limitations, and lack of interest in caring for patients with UI (unpublished).
The Care for Women with Urinary Incontinence Does Not Meet Recommended Standards of Care: With the assistance of co-I Dr. David Reuben, indicators of high quality were developed for vulnerable community-dwelling elders with urinary incontinence. Quality of care for UI was found to be grossly inadequate. In fact, pelvic examination, an important process measure, was performed in only 20% of older women with UI. Only 50% of patients received medical treatment for incontinence, and only 13% were prescribed behavioral modification, despite its proven effectiveness. In a sample of 247 women consecutively referred for new or worsening bothersome UI to FPMRS group practices at Cedars-Sinai, UCLA, and Harbor-UCLA, the investigators found that women ≥75 years of age were less likely than younger women to have received primary care for UI. In fact, older women were less likely to have a focused history obtained that differentiated between SUI and UUI (55% vs 77%, p<0.05), and were less likely to receive a pelvic exam (26% vs 50%, p<0.01) when compared to their younger counterparts. However, rates of behavioral management initiation were low in both older and younger groups, with only 30% of PCPs offering behavioral management (manuscript submitted to the American Journal of Medicine).
Access to Care for Underserved Latinas with Urinary Incontinence is Poor: Access to specialty care, which typically refers to in-person evaluation in a specialty clinic, is insufficient, particularly for underserved populations. Current physician shortages affect subspecialties disproportionately, and will be exacerbated as our population ages. In 2014, there were 3.6 million older adult Hispanics (8% of the older U.S. population); this number is expected to grow to 21.5 million by 2060 (data from the National Hispanic Council on Aging). Hispanic women bear a disproportionate burden of stress and mixed UI, yet may receive inferior care than other ethnic groups. The investigators conducted focus groups to compare perceptions and barriers between Spanish and English speaking women in public and private hospitals being treated for UI. Knowledge gaps were greater among Spanish speakers. Dr. Anger and her research team at UCLA-Olive View Medical Center (public hospital-based outpatient clinics) then sought to evaluate barriers in communication and disease understanding among office staff and interpreters when communicating with Spanish-speaking women with UI. Sixteen office staff and interpreters were interviewed. Patient-related barriers included a lack of understanding of anatomy and medical terminology and inhibited discussions due to embarrassment. Provider-related barriers included poor interpreter knowledge of pelvic floor vocabulary and the frequent use of office staff without interpreting credentials. This work identified obstacles in communication-barriers that only Spanish speaking women face. In this proposal the investigators seek to directly measure and improve the care provided to a heterogeneous population of women with UI, with the goals of improving care, improving UI outcomes, and improving knowledge and shared decision making, while simultaneously removing language barriers.
SIGNIFICANCE This study is significant for several reasons. First, in both study arms the investigators will bring subspecialty expertise to primary care settings, improving on interventions that have been done previously. The investigators will apply a set of QIs that represent the latest patient-centered outcomes research (PCOR) evidence regarding nonsurgical treatments for UI in women, and are all identifiable in the medical record. The QIs the investigators developed are a more comprehensive set than the original ACOVE indicators, developed by subspecialists and primary care providers. Whereas the ACOVE project focused on primary care interventions for UI among older adults at risk of decline, the new indicators distinguish stress vs. urge incontinence, are tailored for management of each type of incontinence, and are applicable across all populations of adult women. The research team's prior work has shown that, in a group of ambulatory patients aged 75+ who screened positive for UI (n=133), better quality of care for UI was associated with a measurable improvement in participant-reported outcomes. Composite quality scores (percentage of QIs passed per participant) and change in Incontinence Quality of Life (IQOL) questionnaire scores (range 0-100) were used as measurements. Each 10% increment in receipt of recommended care for UI was associated with a 1.4-point improvement in IQOL score (p=0.01), a clinically meaningful difference. The investigators expect to see a much larger impact on UI outcomes with this intervention, both arms of which have been tested and shown to make great strides in quality improvement.
There is abundant evidence supporting various nonsurgical management strategies for UI, including behavioral modification, pelvic floor exercises, and initiation of medication for overactive bladder/urge urinary incontinence. However, there are significant barriers to delivery of these strategies at the primary care level. The investigators have identified the two evidenced-based nonsurgical UI care delivery methods that have the greatest impact on care. One study arm to be evaluated is electronic co-management, which has multiple elements, all taken after the successful model created by the Los Angeles County Department of Health Services, the second largest public health care system in the country. eConsult (eConsult Health Ltd, London, England) is an electronic asynchronous consultation tool that was developed with the goals of increasing access, improving dialogue, optimizing efficiency, and enhancing primary care capacity. This infrastructure allows specialists to review electronic referrals and, when needed, return them and make recommendations to the PCP. This model empowers PCPs to more robustly manage conditions, and to streamline care if a specialist visit is necessary. The investigators will implement an electronic consultation system for patients in primary care offices at all sites. The investigators recently compared primary care for UI between private and public systems, and found that the public sector provided better primary care for UI.
The other study arm will be Advanced Practice Provider (APP) co-management. APPs will conduct the patient education portion of the intervention in the primary care setting. APP co-management has been shown to have a greater impact on quality than other educational measures for other chronic conditions affecting older persons, including dementia, and can substantially reduce the work needed on the part of PCPs. APP co-management will also leverage the recent Covid-19 related implementation of telemedicine. This will allow an APP to provide patient-centered care across different offices in a given healthcare system. In addition, based our prior findings of multiple levels of barriers to care for Spanish speaking women with UI, the research team will include certified bilingual APPs in the study so that Spanish speaking women will have a full understanding of what is taught to them. This will increase their knowledge level and allow for shared decision making (SDM) from a more informed perspective. Because UI is a chronic condition, patients need to play an active role in their care and be able to make their own decisions regarding UI management. Therefore, the investigators will also measure whether our intervention improves knowledge and perceived shared decision making. Lastly, the investigators will ensure that these approaches are tested in diverse populations to promote equitable care. As a secondary analysis, the investigators will test whether our proposed intervention reduces disparities in UI care. Should one, or even both, of our proposed interventions be effective in improving quality and outcomes, similar interventions can be easily implemented in most settings. Success of our intervention could lead to wide-scale implementation of effective, yet cost saving, quality improvement methods that reduce the burden of care on PCPs.
- Conditions
- Urinary Incontinence
- Being tested
- APP Co-management, E-consult
- Keywords
- Practice-based intervention, Patient-centered outcomes research, Disparities, Referrals, Quality of care indicators, Primary care
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APP Co-managementOther
To reduce additional burden of care on the PCPs, the investigators will incorporate Advanced Practices Providers into the patient education and self-management portion of care. The APPs will be trained together with the intervention physicians, but they will also undergo additional standardized training on patient education, UI knowledge, providing instruction on Kegel exercises, shared decision making, and self management.
Patients will then be scheduled for a UI education and self-management session with the APP by telemedicine (video visit or telephone visit) within one month of their initial visit. For patients in need of an annual pelvic examination, and if the patient's PCP prefers to have the APP conduct the pelvic exam, a separate visit will be scheduled with the APP. A followup televisit will then be scheduled within three months of the initial APP visit, in order to assess the outcome of non-surgical treatment and determine if a specialist referral is indicated.
E-consultOther
In implementing the electronic consultation system in the private sector, the investigators will model the Expected Practice developed by the Los Angeles County Specialty-Primary Care Work Group. This eConsult system utilizes a "kickback" mechanism by which a specialist, who reviews the referral, can return it if it has not met certain baseline criteria (e.g. for a woman with OAB/urinary urgency: document negative UA, scheduled voids, titrate fluids to thirst, Kegels, antimuscarinics, optimize diuretic control, adjust any diuretics).
| Study group | Role | What they receive |
|---|---|---|
| Electronic Consult (E-consult) | Experimental | In Arm 1, the investigators will implement an electronic referral system (electronic co-management), in which specialists will electronically review referrals and make additional recommendations if appropriate primary UI care was not provided. Receives: Other: E-consult |
| Advanced Practice Provider (APP) Co-management | Experimental | In Arm 2, Advanced Practice Provider (APP) co-management will reduce the burden of care on the PCPs by providing UI care, patient education, and assisting with patient self-management through dedicated televisits (APP co-management). Receives: Other: APP Co-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Quality of Care - Evidence-Based Quality Indicators
Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.
Measured: Baseline
Provider Quality of Care - Evidence-Based Quality Indicators
Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.
Measured: 6 months
Change in provider quality of care measured by evidence-based quality indicators
Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.
Measured: Baseline, 6 months
Secondary outcomes (20)
Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
The ICIQ-SF is a six item questionnaire that assesses the patient's frequency of urinary leakage and how it has negatively impacted their daily activities. The minimum ICIQ score of 0 indicates patient is not bothered by urinary incontinence, while the maximum ICIQ score of 21 indicates the patient's quality of life is negatively impacted a great deal by urinary incontinence.
Measured: Baseline
Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
The ICIQ-SF is a six item questionnaire that assesses the patient's frequency of urinary leakage and how it has negatively impacted their daily activities. The minimum ICIQ score of 0 indicates patient is not bothered by urinary incontinence, while the maximum ICIQ score of 21 indicates the patient's quality of life is negatively impacted a great deal by urinary incontinence.
Measured: 3 months
Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
The ICIQ-SF is a six item questionnaire that assesses the patient's frequency of urinary leakage and how it has negatively impacted their daily activities. The minimum ICIQ score of 0 indicates patient is not bothered by urinary incontinence, while the maximum ICIQ score of 21 indicates the patient's quality of life is negatively impacted a great deal by urinary incontinence.
Measured: 6 months
Change in patients' urinary incontinence symptoms as measured by ICIQ-SF
The ICIQ-SF is a six item questionnaire that assesses the patient's frequency of urinary leakage and how it has negatively impacted their daily activities. The minimum ICIQ score of 0 indicates patient is not bothered by urinary incontinence, while the maximum ICIQ score of 21 indicates the patient's quality of life is negatively impacted a great deal by urinary incontinence.
Measured: Baseline, 3 months, 6 months
Patient Symptoms - Urogenital Distress Inventory (UDI-6)
The UDI-6 is the urinary incontinence (UI) assessment tool endorsed by the American Urological Association and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). It contains only 6 questions and differentiates the type of UI (SUI vs. UUI), symptoms associated with UI, severity of symptoms and symptom bother. Furthermore, the UDI-6 gives a summative score that has been demonstrated to be sensitive to change with treatment and correlates with quality of life indices.
Measured: Baseline
Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6)
The UDI-6 is the urinary incontinence (UI) assessment tool endorsed by the American Urological Association and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). It contains only 6 questions and differentiates the type of UI (SUI vs. UUI), symptoms associated with UI, severity of symptoms and symptom bother. Furthermore, the UDI-6 gives a summative score that has been demonstrated to be sensitive to change with treatment and correlates with quality of life indices.
Measured: 3 months
Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6)
The UDI-6 is the urinary incontinence (UI) assessment tool endorsed by the American Urological Association and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). It contains only 6 questions and differentiates the type of UI (SUI vs. UUI), symptoms associated with UI, severity of symptoms and symptom bother. Furthermore, the UDI-6 gives a summative score that has been demonstrated to be sensitive to change with treatment and correlates with quality of life indices.
Measured: 6 months
Change in patients' urinary symptoms as measured by UDI-6
The UDI-6 is the urinary incontinence (UI) assessment tool endorsed by the American Urological Association and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). It contains only 6 questions and differentiates the type of UI (SUI vs. UUI), symptoms associated with UI, severity of symptoms and symptom bother. Furthermore, the UDI-6 gives a summative score that has been demonstrated to be sensitive to change with treatment and correlates with quality of life indices.
Measured: Baseline, 3 months, 6 months
Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
The IIQ-7 is a seven-item questionnaire that assesses the impact of UI on health-related quality of life, with the minimum score of 0 indicating no impact and a maximum score of 21 indicating significant disruption of daily activities, relationships, and feelings.
Measured: Baseline
Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
The IIQ-7 is a seven-item questionnaire that assesses the impact of UI on health-related quality of life, with the minimum score of 0 indicating no impact and a maximum score of 21 indicating significant disruption of daily activities, relationships, and feelings.
Measured: 3 months
Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
The IIQ-7 is a seven-item questionnaire that assesses the impact of UI on health-related quality of life, with the minimum score of 0 indicating no impact and a maximum score of 21 indicating significant disruption of daily activities, relationships, and feelings.
Measured: 6 months
Change in impact of UI on patients' quality of life as measure by the Incontinence Impact Questionnaire (IIQ-7)
The IIQ-7 is a seven-item questionnaire that assesses the impact of UI on health-related quality of life, with the minimum score of 0 indicating no impact and a maximum score of 21 indicating significant disruption of daily activities, relationships, and feelings.
Measured: Baseline, 3 months, 6 months
Patient Decision Making - Shared Decision Making Questionnaire (SDM-Q-9)
Nine-item questionnaire that measures the extent to which patients are involved in the process of decision-making. This questionnaire requires patients to indicate how strongly they agree with given statements on a scale (completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, completely agree).
Measured: 3 months
Patient Satisfaction - Net Promoter Score
The Net Promoter Score evaluates a patient's willingness to refer a friend to the provider from whom they received care and to the institution where they received care. Patients respond on a 5-item Likert score on how likely they would be to make the referrals. Patients are ranked as "Detractors", "Passive", and "Promoters". The Net Promoter Score is calculated by subtracting the group percentage of "Promoters" from the group percentage of "Detractors."
Measured: 3 months
Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
Thirty-one-item questionnaire assessing patient knowledge in three domains: POP (11 items), SUI (10 items) and OAB (10 items) with questions on condition pathophysiology, management, and quality of life.
Measured: Baseline
Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
Thirty-one-item questionnaire assessing patient knowledge in three domains: POP (11 items), SUI (10 items) and OAB (10 items) with questions on condition pathophysiology, management, and quality of life.
Measured: 6 months
Change in patients' knowledge as measured by the P-FAKS
Thirty-one-item questionnaire assessing patient knowledge in three domains: POP (11 items), SUI (10 items) and OAB (10 items) with questions on condition pathophysiology, management, and quality of life.
Measured: Baseline, 6 months
Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
Nine-item questionnaire that measures the extent to which patients are involved in the process of decision-making. This questionnaire requires patients to indicate how strongly they agree with given statements on a scale (completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, completely agree).
Measured: Baseline
Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
Thirty-one-item questionnaire assessing patient knowledge in three domains: POP (11 items), SUI (10 items) and OAB (10 items) with questions on condition pathophysiology, management, and quality of life.
Measured: 6 months
Change in provider knowledge as measured by the P-FAKS
Thirty-one-item questionnaire assessing patient knowledge in three domains: POP (11 items), SUI (10 items) and OAB (10 items) with questions on condition pathophysiology, management, and quality of life.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start16 Feb 2024
- Primary completion1 Apr 2028 (estimated)
- Study completion8 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, University of Kansas, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Jennifer Anger, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040645
- Sponsor's protocol ID
- 806024
- Acronym
- OUTPACE
- Status last verified
- Mar 2026
- First submitted
- 22 Jun 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available by request.
Publications
Dieter AA, Wilkins MF, Wu JM. Epidemiological trends and future care needs for pelvic floor disorders. Curr Opin Obstet Gynecol. 2015 Oct;27(5):380-4. doi: 10.1097/GCO.0000000000000200.
PubMed 26308198Anger JT, Scott VC, Kiyosaki K, Khan AA, Weinberg A, Connor SE, Roth CP, Wenger N, Shekelle P, Litwin MS. Development of quality indicators for women with urinary incontinence. Neurourol Urodyn. 2013 Nov;32(8):1058-63. doi: 10.1002/nau.22353. Epub 2013 Sep 16.
PubMed 24105879Anger JT, Alas A, Litwin MS, Chu SD, Bresee C, Roth CP, Rashid R, Shekelle P, Wenger NS. The Quality of Care Provided to Women with Urinary Incontinence in 2 Clinical Settings. J Urol. 2016 Oct;196(4):1196-200. doi: 10.1016/j.juro.2016.05.005. Epub 2016 May 7.
PubMed 27164512Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
PubMed 12559262Anger JT, Saigal CS, Litwin MS; Urologic Diseases of America Project. The prevalence of urinary incontinence among community dwelling adult women: results from the National Health and Nutrition Examination Survey. J Urol. 2006 Feb;175(2):601-4. doi: 10.1016/S0022-5347(05)00242-9.
PubMed 16407004Markland AD, Richter HE, Fwu CW, Eggers P, Kusek JW. Prevalence and trends of urinary incontinence in adults in the United States, 2001 to 2008. J Urol. 2011 Aug;186(2):589-93. doi: 10.1016/j.juro.2011.03.114.
PubMed 21684555Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
PubMed 19935030Mesens T, Aich A, Bhal PS. Late erosions of mid-urethral tapes for stress urinary incontinence--need for long-term follow-up? Int Urogynecol J Pelvic Floor Dysfunct. 2007 Sep;18(9):1113-4. doi: 10.1007/s00192-007-0301-4. Epub 2007 Mar 9.
PubMed 17347793Schnelle JF, Smith RL. Quality indicators for the management of urinary incontinence in vulnerable community-dwelling elders. Ann Intern Med. 2001 Oct 16;135(8 Pt 2):752-8. doi: 10.7326/0003-4819-135-8_part_2-200110161-00015. No abstract available.
PubMed 11601959Gnanadesigan N, Saliba D, Roth CP, Solomon DH, Chang JT, Schnelle J, Smith R, Shekelle PG, Wenger NS. The quality of care provided to vulnerable older community-based patients with urinary incontinence. J Am Med Dir Assoc. 2004 May-Jun;5(3):141-6. doi: 10.1097/01.JAM.0000123026.47700.1A.
PubMed 15115573Bisgaier J, Rhodes KV. Auditing access to specialty care for children with public insurance. N Engl J Med. 2011 Jun 16;364(24):2324-33. doi: 10.1056/NEJMsa1013285.
PubMed 21675891Rhodes KV, Bisgaier J, Lawson CC, Soglin D, Krug S, Van Haitsma M. "Patients who can't get an appointment go to the ER": access to specialty care for publicly insured children. Ann Emerg Med. 2013 Apr;61(4):394-403. doi: 10.1016/j.annemergmed.2012.10.030. Epub 2013 Jan 8.
PubMed 23312670Mehrotra A, Forrest CB, Lin CY. Dropping the baton: specialty referrals in the United States. Milbank Q. 2011 Mar;89(1):39-68. doi: 10.1111/j.1468-0009.2011.00619.x.
PubMed 21418312Dall TM, Gallo PD, Chakrabarti R, West T, Semilla AP, Storm MV. An aging population and growing disease burden will require a large and specialized health care workforce by 2025. Health Aff (Millwood). 2013 Nov;32(11):2013-20. doi: 10.1377/hlthaff.2013.0714.
PubMed 24191094McKibben MJ, Kirby EW, Langston J, Raynor MC, Nielsen ME, Smith AB, Wallen EM, Woods ME, Pruthi RS. Projecting the Urology Workforce Over the Next 20 Years. Urology. 2016 Dec;98:21-26. doi: 10.1016/j.urology.2016.07.028. Epub 2016 Aug 1.
PubMed 27491965
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Urinary Incontinence Treatment in Primary Care: APP Co-Management and Electronic Consult
- ClinicalTrials.gov ID
- NCT06040645
- Acronym / sponsor ID
- OUTPACE / 806024
- Conditions
- Urinary Incontinence
- Keywords
- Practice-based intervention, Patient-centered outcomes research, Disparities, Referrals, Quality of care indicators, Primary care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of Kansas, Patient-Centered Outcomes Research Institute
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 8 Nov 2029 (estimated)
- First posted
- 15 Sep 2023 (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.
The burden of urinary incontinence (UI) on American women is immense in both human and financial terms, and continues to rise with the aging US population. Although numerous non-surgical management strategies have proven efficacy for both stress and urge urinary incontinence, there remains a lack of appropriate UI management in the primary care setting. The goal of this multi-site cluster randomized comparative effectiveness trial is to compare the effects of two methods of nonsurgical UI care delivery - electronic consult vs. advanced practice provider (APP) co-management. These two evidence-based, practice-changing strategies are designed to improve the quality of care for an ethnically diverse population of women with UI, and, by reducing deficits in care, obtain better patient-reported outcomes. Both arms of the study will include basic physician education (academic detailing) and electronic clinical decision support. In Arm 1, the investigators will implement an electronic referral system (electronic referral), in which specialists will electronically review referrals and make additional recommendations if appropriate primary UI care was not provided. In Arm 2, Advanced Practice Provider (APP) co-management will reduce the burden of care on the PCPs by providing UI care, patient education, and assisting with patient self-management through dedicated televisits (APP co-management).
Detailed description
The Burden of Urinary Incontinence on American Women is Immense: Although a great deal of research on quality of care has been conducted in many areas of medicine and surgery, there remains a relative paucity of data regarding the quality of care for women with urinary incontinence (UI). UI is defined by the International Continence Society as the complaint of any involuntary leakage of urine. The burden of UI on American women is immense in both human and financial terms, and continues to rise with the aging population. According to the National Health and Nutrition Examination Survey, the prevalence of UI among women ranges from 38%-53%. The lifetime risk of undergoing surgery for UI or pelvic organ prolapse is 20%. With the aging of the baby boomers it is projected that the number of women with UI will increase by 55% by 2050. UI negatively impacts health-related quality of life and is associated with embarrassment, stigma, and social isolation.
Primary Care Interventions for UI are Needed. In prior research by our team to provide background for the current proposal, the investigators sought to qualitatively assess challenges and barriers that primary care providers (PCPs) experience in caring for patients with UI. Twelve providers from the specialties of family medicine, general internal medicine, and geriatrics were interviewed. Providers described a lack of understanding of important components of a pelvic exam. Some male providers mentioned their own discomfort performing a pelvic exam on women. PCPs also discussed uncertainty in reaching a correct UI diagnosis (stress urinary incontinence, SUI, vs. urge urinary incontinence, UUI). There were also concerns about anticholinergic drug interactions and their association with cognitive impairment. There was a general lack of familiarity with medication options and dosing and a lack of knowledge about logistics in referring to pelvic floor physical therapy. Providers mentioned the need for an algorithm for the treatment of UI. They also described systems barriers included competing priorities with other medical issues, time limitations, and lack of interest in caring for patients with UI (unpublished).
The Care for Women with Urinary Incontinence Does Not Meet Recommended Standards of Care: With the assistance of co-I Dr. David Reuben, indicators of high quality were developed for vulnerable community-dwelling elders with urinary incontinence. Quality of care for UI was found to be grossly inadequate. In fact, pelvic examination, an important process measure, was performed in only 20% of older women with UI. Only 50% of patients received medical treatment for incontinence, and only 13% were prescribed behavioral modification, despite its proven effectiveness. In a sample of 247 women consecutively referred for new or worsening bothersome UI to FPMRS group practices at Cedars-Sinai, UCLA, and Harbor-UCLA, the investigators found that women ≥75 years of age were less likely than younger women to have received primary care for UI. In fact, older women were less likely to have a focused history obtained that differentiated between SUI and UUI (55% vs 77%, p<0.05), and were less likely to receive a pelvic exam (26% vs 50%, p<0.01) when compared to their younger counterparts. However, rates of behavioral management initiation were low in both older and younger groups, with only 30% of PCPs offering behavioral management (manuscript submitted to the American Journal of Medicine).
Access to Care for Underserved Latinas with Urinary Incontinence is Poor: Access to specialty care, which typically refers to in-person evaluation in a specialty clinic, is insufficient, particularly for underserved populations. Current physician shortages affect subspecialties disproportionately, and will be exacerbated as our population ages. In 2014, there were 3.6 million older adult Hispanics (8% of the older U.S. population); this number is expected to grow to 21.5 million by 2060 (data from the National Hispanic Council on Aging). Hispanic women bear a disproportionate burden of stress and mixed UI, yet may receive inferior care than other ethnic groups. The investigators conducted focus groups to compare perceptions and barriers between Spanish and English speaking women in public and private hospitals being treated for UI. Knowledge gaps were greater among Spanish speakers. Dr. Anger and her research team at UCLA-Olive View Medical Center (public hospital-based outpatient clinics) then sought to evaluate barriers in communication and disease understanding among office staff and interpreters when communicating with Spanish-speaking women with UI. Sixteen office staff and interpreters were interviewed. Patient-related barriers included a lack of understanding of anatomy and medical terminology and inhibited discussions due to embarrassment. Provider-related barriers included poor interpreter knowledge of pelvic floor vocabulary and the frequent use of office staff without interpreting credentials. This work identified obstacles in communication-barriers that only Spanish speaking women face. In this proposal the investigators seek to directly measure and improve the care provided to a heterogeneous population of women with UI, with the goals of improving care, improving UI outcomes, and improving knowledge and shared decision making, while simultaneously removing language barriers.
SIGNIFICANCE This study is significant for several reasons. First, in both study arms the investigators will bring subspecialty expertise to primary care settings, improving on interventions that have been done previously. The investigators will apply a set of QIs that represent the latest patient-centered outcomes research (PCOR) evidence regarding nonsurgical treatments for UI in women, and are all identifiable in the medical record. The QIs the investigators developed are a more comprehensive set than the original ACOVE indicators, developed by subspecialists and primary care providers. Whereas the ACOVE project focused on primary care interventions for UI among older adults at risk of decline, the new indicators distinguish stress vs. urge incontinence, are tailored for management of each type of incontinence, and are applicable across all populations of adult women. The research team's prior work has shown that, in a group of ambulatory patients aged 75+ who screened positive for UI (n=133), better quality of care for UI was associated with a measurable improvement in participant-reported outcomes. Composite quality scores (percentage of QIs passed per participant) and change in Incontinence Quality of Life (IQOL) questionnaire scores (range 0-100) were used as measurements. Each 10% increment in receipt of recommended care for UI was associated with a 1.4-point improvement in IQOL score (p=0.01), a clinically meaningful difference. The investigators expect to see a much larger impact on UI outcomes with this intervention, both arms of which have been tested and shown to make great strides in quality improvement.
There is abundant evidence supporting various nonsurgical management strategies for UI, including behavioral modification, pelvic floor exercises, and initiation of medication for overactive bladder/urge urinary incontinence. However, there are significant barriers to delivery of these strategies at the primary care level. The investigators have identified the two evidenced-based nonsurgical UI care delivery methods that have the greatest impact on care. One study arm to be evaluated is electronic co-management, which has multiple elements, all taken after the successful model created by the Los Angeles County Department of Health Services, the second largest public health care system in the country. eConsult (eConsult Health Ltd, London, England) is an electronic asynchronous consultation tool that was developed with the goals of increasing access, improving dialogue, optimizing efficiency, and enhancing primary care capacity. This infrastructure allows specialists to review electronic referrals and, when needed, return them and make recommendations to the PCP. This model empowers PCPs to more robustly manage conditions, and to streamline care if a specialist visit is necessary. The investigators will implement an electronic consultation system for patients in primary care offices at all sites. The investigators recently compared primary care for UI between private and public systems, and found that the public sector provided better primary care for UI.
The other study arm will be Advanced Practice Provider (APP) co-management. APPs will conduct the patient education portion of the intervention in the primary care setting. APP co-management has been shown to have a greater impact on quality than other educational measures for other chronic conditions affecting older persons, including dementia, and can substantially reduce the work needed on the part of PCPs. APP co-management will also leverage the recent Covid-19 related implementation of telemedicine. This will allow an APP to provide patient-centered care across different offices in a given healthcare system. In addition, based our prior findings of multiple levels of barriers to care for Spanish speaking women with UI, the research team will include certified bilingual APPs in the study so that Spanish speaking women will have a full understanding of what is taught to them. This will increase their knowledge level and allow for shared decision making (SDM) from a more informed perspective. Because UI is a chronic condition, patients need to play an active role in their care and be able to make their own decisions regarding UI management. Therefore, the investigators will also measure whether our intervention improves knowledge and perceived shared decision making. Lastly, the investigators will ensure that these approaches are tested in diverse populations to promote equitable care. As a secondary analysis, the investigators will test whether our proposed intervention reduces disparities in UI care. Should one, or even both, of our proposed interventions be effective in improving quality and outcomes, similar interventions can be easily implemented in most settings. Success of our intervention could lead to wide-scale implementation of effective, yet cost saving, quality improvement methods that reduce the burden of care on PCPs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic Consult (E-consult) | Experimental | Other: E-consultIn Arm 1, the investigators will implement an electronic referral system (electronic co-management), in which specialists will electronically review referrals and make additional recommendations if appropriate primary UI care was not provided. |
| Advanced Practice Provider (APP) Co-management | Experimental | Other: APP Co-managementIn Arm 2, Advanced Practice Provider (APP) co-management will reduce the burden of care on the PCPs by providing UI care, patient education, and assisting with patient self-management through dedicated televisits (APP co-management). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary care physician belonging to a recruited office among one of three participating sites: UCSD, UCLA, KUMC
- Age \>18 y/o
- English or Spanish fluency
- Female
- Answers \"yes\" to incontinence screening tool and agrees to participate
Key exclusion criteria (5 listed)
- Non-primary care specialty
- Does not belong to one of the participating offices
- Age \<18 y/o
- Answers \"no\" to incontinence screening tool and/or does not agree to participate
- Primary care provider (who reviews a list of patients that screen positive) deems patient ineligible due to pregnant, severe memory impairment, or psychiatric history preventing participation
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 |
|---|---|---|
| APP Co-managementTo reduce additional burden of care on the PCPs, the investigators will incorporate Advanced Practices Providers into the patient education and self-management portion of care. The APPs will be trained together with the intervention physicians, but they will also undergo additional standardized training on patient education, UI knowledge, providing instruction on Kegel exercises, shared decision making, and self management. Patients will then be scheduled for a UI education and self-management session with the APP by telemedicine (video visit or telephone visit) within one month of their initial visit. For patients in need of an annual pelvic examination, and if the patient's PCP prefers to have the APP conduct the pelvic exam, a separate visit will be scheduled with the APP. A followup televisit will then be scheduled within three months of the initial APP visit, in order to assess the outcome of non-surgical treatment and determine if a specialist referral is indicated. | Other | Advanced Practice Provider (APP) Co-management |
| E-consultIn implementing the electronic consultation system in the private sector, the investigators will model the Expected Practice developed by the Los Angeles County Specialty-Primary Care Work Group. This eConsult system utilizes a "kickback" mechanism by which a specialist, who reviews the referral, can return it if it has not met certain baseline criteria (e.g. for a woman with OAB/urinary urgency: document negative UA, scheduled voids, titrate fluids to thirst, Kegels, antimuscarinics, optimize diuretic control, adjust any diuretics). | Other | Electronic Consult (E-consult) |
Primary outcome
Provider Quality of Care - Evidence-Based Quality Indicators
Time frame: Baseline
Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.
Provider Quality of Care - Evidence-Based Quality Indicators
Time frame: 6 months
Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.
Change in provider quality of care measured by evidence-based quality indicators
Time frame: Baseline, 6 months
Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.
20 secondary outcomes
Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
Time frame: Baseline
Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
Time frame: 3 months
Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
Time frame: 6 months
Change in patients' urinary incontinence symptoms as measured by ICIQ-SF
Time frame: Baseline, 3 months, 6 months
Patient Symptoms - Urogenital Distress Inventory (UDI-6)
Time frame: Baseline
Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6)
Time frame: 3 months
Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6)
Time frame: 6 months
Change in patients' urinary symptoms as measured by UDI-6
Time frame: Baseline, 3 months, 6 months
Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
Time frame: Baseline
Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
Time frame: 3 months
Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
Time frame: 6 months
Change in impact of UI on patients' quality of life as measure by the Incontinence Impact Questionnaire (IIQ-7)
Time frame: Baseline, 3 months, 6 months
Patient Decision Making - Shared Decision Making Questionnaire (SDM-Q-9)
Time frame: 3 months
Patient Satisfaction - Net Promoter Score
Time frame: 3 months
Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
Time frame: Baseline
Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
Time frame: 6 months
Change in patients' knowledge as measured by the P-FAKS
Time frame: Baseline, 6 months
Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
Time frame: Baseline
Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
Time frame: 6 months
Change in provider knowledge as measured by the P-FAKS
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 26308198Dieter AA, Wilkins MF, Wu JM. Epidemiological trends and future care needs for pelvic floor disorders. Curr Opin Obstet Gynecol. 2015 Oct;27(5):380-4. doi: 10.1097/GCO.0000000000000200.
- Background: PubMed 24105879Anger JT, Scott VC, Kiyosaki K, Khan AA, Weinberg A, Connor SE, Roth CP, Wenger N, Shekelle P, Litwin MS. Development of quality indicators for women with urinary incontinence. Neurourol Urodyn. 2013 Nov;32(8):1058-63. doi: 10.1002/nau.22353. Epub 2013 Sep 16.
- Background: PubMed 27164512Anger JT, Alas A, Litwin MS, Chu SD, Bresee C, Roth CP, Rashid R, Shekelle P, Wenger NS. The Quality of Care Provided to Women with Urinary Incontinence in 2 Clinical Settings. J Urol. 2016 Oct;196(4):1196-200. doi: 10.1016/j.juro.2016.05.005. Epub 2016 May 7.
- Background: PubMed 12559262Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
- Background: PubMed 16407004Anger JT, Saigal CS, Litwin MS; Urologic Diseases of America Project. The prevalence of urinary incontinence among community dwelling adult women: results from the National Health and Nutrition Examination Survey. J Urol. 2006 Feb;175(2):601-4. doi: 10.1016/S0022-5347(05)00242-9.
- Background: PubMed 21684555Markland AD, Richter HE, Fwu CW, Eggers P, Kusek JW. Prevalence and trends of urinary incontinence in adults in the United States, 2001 to 2008. J Urol. 2011 Aug;186(2):589-93. doi: 10.1016/j.juro.2011.03.114.
- Background: PubMed 19935030Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
- Background: PubMed 17347793Mesens T, Aich A, Bhal PS. Late erosions of mid-urethral tapes for stress urinary incontinence--need for long-term follow-up? Int Urogynecol J Pelvic Floor Dysfunct. 2007 Sep;18(9):1113-4. doi: 10.1007/s00192-007-0301-4. Epub 2007 Mar 9.
- Background: PubMed 11601959Schnelle JF, Smith RL. Quality indicators for the management of urinary incontinence in vulnerable community-dwelling elders. Ann Intern Med. 2001 Oct 16;135(8 Pt 2):752-8. doi: 10.7326/0003-4819-135-8_part_2-200110161-00015. No abstract available.
- Background: PubMed 15115573Gnanadesigan N, Saliba D, Roth CP, Solomon DH, Chang JT, Schnelle J, Smith R, Shekelle PG, Wenger NS. The quality of care provided to vulnerable older community-based patients with urinary incontinence. J Am Med Dir Assoc. 2004 May-Jun;5(3):141-6. doi: 10.1097/01.JAM.0000123026.47700.1A.
- Background: PubMed 21675891Bisgaier J, Rhodes KV. Auditing access to specialty care for children with public insurance. N Engl J Med. 2011 Jun 16;364(24):2324-33. doi: 10.1056/NEJMsa1013285.
- Background: PubMed 23312670Rhodes KV, Bisgaier J, Lawson CC, Soglin D, Krug S, Van Haitsma M. "Patients who can't get an appointment go to the ER": access to specialty care for publicly insured children. Ann Emerg Med. 2013 Apr;61(4):394-403. doi: 10.1016/j.annemergmed.2012.10.030. Epub 2013 Jan 8.
- Individual participant dataSharing planned: Yes. Available by request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APP Co-management and E-consult in people with Urinary Incontinence, run by University of California, San Diego at 3 sites 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 5 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Provider Quality of Care - Evidence-Based Quality Indicators (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT06040645, which also lists 27 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 13 Mar 2026.