Urinary Incontinence Clinical Trial
— OUTPACEOfficial title:
Outcomes of Urinary Incontinence Treatment in Primary Care: APP Co-Management and Electronic Consult
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).
Status | Not yet recruiting |
Enrollment | 1200 |
Est. completion date | April 1, 2027 |
Est. primary completion date | February 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria of Primary Care Physicians: - Primary care physician belonging to a recruited office among one of three participating sites: UCSD, UCLA, KUMC Inclusion Criteria of Patients: - Age >18 y/o - English or Spanish fluency - Female - Answers "yes" to incontinence screening tool and agrees to participate Exclusion Criteria of Primary Care Physicians: - Non-primary care specialty - Does not belong to one of the participating offices Exclusion Criteria of Patients: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Patient-Centered Outcomes Research Institute, University of California, Los Angeles, University of Kansas |
Abrams 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. — View Citation
Alas AN, Dunivan GC, Wieslander CK, Sevilla C, Barrera B, Rashid R, Maliski S, Eilber K, Rogers RG, Anger JT. Health Care Disparities Among English-Speaking and Spanish-Speaking Women With Pelvic Organ Prolapse at Public and Private Hospitals: What Are the Barriers? Female Pelvic Med Reconstr Surg. 2016 Nov/Dec;22(6):460-466. doi: 10.1097/SPV.0000000000000315. — View Citation
Anger 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. — View Citation
Anger 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. — View Citation
Anger 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. — View Citation
Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025. — View Citation
Barnett ML, Yee HF Jr, Mehrotra A, Giboney P. Los Angeles Safety-Net Program eConsult System Was Rapidly Adopted And Decreased Wait Times To See Specialists. Health Aff (Millwood). 2017 Mar 1;36(3):492-499. doi: 10.1377/hlthaff.2016.1283. — View Citation
Bisgaier 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. — View Citation
Bordeianou LG, Anger JT, Boutros M, Birnbaum E, Carmichael JC, Connell KA, De EJB, Mellgren A, Staller K, Vogler SA, Weinstein MM, Yafi FA, Hull TL; Members of the Pelvic Floor Disorders Consortium Working Groups on Patient-Reported Outcomes. Measuring Pelvic Floor Disorder Symptoms Using Patient-Reported Instruments: Proceedings of the Consensus Meeting of the Pelvic Floor Consortium of the American Society of Colon and Rectal Surgeons, the International Continence Society, the American Urogynecologic Society, and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction. Female Pelvic Med Reconstr Surg. 2020 Jan/Feb;26(1):1-15. doi: 10.1097/SPV.0000000000000817. No abstract available. — View Citation
Dall 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. — View Citation
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. — View Citation
Gnanadesigan 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. — View Citation
Jennings LA, Tan Z, Wenger NS, Cook EA, Han W, McCreath HE, Serrano KS, Roth CP, Reuben DB. Quality of Care Provided by a Comprehensive Dementia Care Comanagement Program. J Am Geriatr Soc. 2016 Aug;64(8):1724-30. doi: 10.1111/jgs.14251. Epub 2016 Jun 29. — View Citation
Khan AA, Sevilla C, Wieslander CK, Moran MB, Rashid R, Mittal B, Maliski SL, Rogers RG, Anger JT. Communication barriers among Spanish-speaking women with pelvic floor disorders: lost in translation? Female Pelvic Med Reconstr Surg. 2013 May-Jun;19(3):157-64. doi: 10.1097/SPV.0b013e318288ac1c. — View Citation
Markland 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. — View Citation
McGlynn EA, Asch SM, Adams J, Keesey J, Hicks J, DeCristofaro A, Kerr EA. The quality of health care delivered to adults in the United States. N Engl J Med. 2003 Jun 26;348(26):2635-45. doi: 10.1056/NEJMsa022615. — View Citation
McKibben 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. — View Citation
Mehrotra 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. — View Citation
Mesens 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. — View Citation
Min LC, Reuben DB, Adams J, Shekelle PG, Ganz DA, Roth CP, Wenger NS. Does better quality of care for falls and urinary incontinence result in better participant-reported outcomes? J Am Geriatr Soc. 2011 Aug;59(8):1435-43. doi: 10.1111/j.1532-5415.2011.03517.x. Epub 2011 Aug 1. — View Citation
Min LC, Reuben DB, MacLean CH, Shekelle PG, Solomon DH, Higashi T, Chang JT, Roth CP, Kamberg CJ, Adams J, Young RT, Wenger NS. Predictors of overall quality of care provided to vulnerable older people. J Am Geriatr Soc. 2005 Oct;53(10):1705-11. doi: 10.1111/j.1532-5415.2005.53520.x. — View Citation
Rhodes 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. — View Citation
Schnelle 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. — View Citation
Soni SM, Giboney P, Yee HF Jr. Development and Implementation of Expected Practices to Reduce Inappropriate Variations in Clinical Practice. JAMA. 2016 May 24-31;315(20):2163-4. doi: 10.1001/jama.2016.4255. No abstract available. — View Citation
Wu 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. — View Citation
Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379. — View Citation
* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline | |
Primary | 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. | 6 months | |
Primary | 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. | Baseline, 6 months | |
Secondary | 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. | Baseline | |
Secondary | 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. | 3 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | Baseline, 3 months, 6 months | |
Secondary | 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. | Baseline | |
Secondary | 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. | 3 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | Baseline, 3 months, 6 months | |
Secondary | 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. | Baseline | |
Secondary | 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. | 3 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | Baseline, 3 months, 6 months | |
Secondary | 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). | 3 months | |
Secondary | 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." | 3 months | |
Secondary | 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. | Baseline | |
Secondary | 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. | 6 months | |
Secondary | 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. | Baseline, 6 months | |
Secondary | 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). | Baseline | |
Secondary | 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. | 6 months | |
Secondary | 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. | Baseline, 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05534412 -
A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence
|
N/A | |
Recruiting |
NCT05515198 -
Improving Care for Women With Urinary Incontinence (EMPOWER)
|
N/A | |
Completed |
NCT04071301 -
Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence
|
N/A | |
Completed |
NCT03623880 -
Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
|
N/A | |
Recruiting |
NCT05880862 -
Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
|
Early Phase 1 | |
Recruiting |
NCT04159467 -
Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet
|
N/A | |
Completed |
NCT05485922 -
Performance of a Single-use Intermittent Micro-hole Zone Catheter
|
N/A | |
Completed |
NCT06268782 -
The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women
|
N/A | |
Not yet recruiting |
NCT03027986 -
Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy
|
N/A | |
Recruiting |
NCT02490917 -
ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence
|
N/A | |
Enrolling by invitation |
NCT02530372 -
Feasibility of the UriCap-F for Urine Collection in Hospitalized Women
|
N/A | |
Enrolling by invitation |
NCT02529371 -
Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
|
N/A | |
Completed |
NCT02338726 -
Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study
|
N/A | |
Completed |
NCT02549729 -
Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy
|
N/A | |
Completed |
NCT02600676 -
Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
|
N/A | |
Completed |
NCT02368262 -
Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy
|
N/A | |
Completed |
NCT02239796 -
Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence
|
N/A | |
Completed |
NCT01942681 -
Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride
|
N/A | |
Recruiting |
NCT01804153 -
Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)
|
Phase 1/Phase 2 | |
Completed |
NCT01520948 -
Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease
|
Phase 3 |