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Completed

NCT Number: NCT05515198

Improving Care for Women With Urinary Incontinence (EMPOWER)

The overall goal is to improve diagnosis and non-operative management of urinary incontinence in women.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

About this study

In the study, patients will be screened in primary care offices for symptoms of urinary incontinence. Women with positive screening results will be asked if they are interested in participating in an implementation study where women will be assigned to one of the three following groups:

  • Usual Care plus Patient Educational Opportunities - The patient's urinary incontinence will be managed using standard of care treatment by the patient's primary care provider. Patients will be offered educational opportunities about urinary incontinence.
  • Nurse Navigation - Along with the treatment described for "Usual Care plus Patient Educational Opportunities," a nurse navigator will work with the patient to implement behavioral changes and provide education and physical therapy options. In addition, the navigator will be available to answer the patient's questions in a timely fashion and help the patient move through the care pathway.
  • Nurse Navigation and ChatBot - Along with the treatment described for "Usual Care plus Patient Educational Opportunities" and "Nurse Navigation," this group will include a ChatBot feature which will allow a patient to directly and privately communicate with an artificial intelligence-driven ChatBot, also known as a "conversational agent," that will provide education and help the patient navigate the care pathway.

All participants will complete questionnaires throughout their enrollment and data will be collected from medical records. The study team will analyze the data at six months after the original appointment/study enrollment, assess adherence to therapy and how the therapy impacted the outcomes the team hopes to improve, such as improvement in symptoms. The study will be implemented over three subsequent time periods called Wave 1, Wave 2 and Wave 3 with primary care practices from two geographic regions being involved in each wave (6 regions total). Participants in Wave 1 will be followed for a total of 18 months, while participants in Wave 2 will be followed for a total of 12 months, and participants in Wave 3 will be followed for 6 months. Primary care providers at all participating practices will be offered educational opportunities related to urinary incontinence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patient having a primary care provider visit at University Hospitals (UH) Cleveland Primary Care Institute (PCI)
  • ≥ 18 years old
  • Scores 1 or higher on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)

Exclusion criteria

None

Treatment and study plan

Patient Education

Other

Patients will be provided educational opportunities.

Other names: Education

Nurse Navigation

Other

A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.

chatbot

Other

A ChatBot will allow participants to directly and privately communicate through a smartphone (or other device) with an artificial intelligence-driven ChatBot, also known as a "conversational agent," that will provide education and encouragement to manage their symptoms.

Other names: Behavioral/exercise via chatbot

Primary outcomes

  1. Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

    Time frame: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each wave

    The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.

  2. Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

    Time frame: 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12)

    The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.

Secondary outcomes

  1. Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

    Time frame: 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)

    The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.

  2. Change in Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI

    Time frame: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave

    Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient-Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI. The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy.

  3. Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI

    Time frame: 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only lasted 6 months, not 12)

    Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient- Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI. The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy.

  4. Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI

    Time frame: 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)

    Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient- Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI. The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy.

  5. Patient Empowerment as Measured by Number of Participants That Answered Yes to Speaking With Their Provider About UI.

    Time frame: Baseline (immediately prior to start of intervention) in all Waves

    Patient empowerment will be measured by a patient survey to measure with percentage of patients answering yes to speaking with their provider about UI.

  6. Change in Overactive Bladder Symptom Severity as Measured by the OABSS

    Time frame: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave

    Patients' overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS). The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms.

  7. Overactive Bladder Symptom Severity as Measured by the OABSS

    Time frame: 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participant only last 6 months, not 12)

    Patients' overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS). The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms.

  8. Overactive Bladder Symptom Severity as Measured by the OABSS

    Time frame: 18 months post start of intervention in Wave 1 (no data collected for Wave 2 and 3 participants)

    Overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS). The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms.

  9. Change in Urinary Symptoms as Measured by the UDI-6

    Time frame: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave

    How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6). The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms.

  10. Urinary Symptoms as Measured by the UDI-6

    Time frame: 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only lasted 6 months, not 12)

    How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6). The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms.

  11. Urinary Symptoms as Measured by the UDI-6

    Time frame: 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)

    How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6). The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms.

  12. Change in Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol

    Time frame: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave

    The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life.

  13. Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol

    Time frame: 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12)

    The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life.

  14. Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol

    Time frame: 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)

    The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life.

  15. Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale.

    Time frame: Months 2 and 6 post start of intervention in each Wave

    Patients' perceived improvement in UI symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I). PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse." Reported outcome measure is the number of participants that scored better (1, 2, or 3) at each time point. For improvement it was calculated the number of participants who chose 1-3 only.

  16. Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale.

    Time frame: 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12)

    Patients' perceived improvement in UI symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I). PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse." Reported outcome measure is the number of participants that scored better (1, 2, or 3) at each time point. For improvement it was calculated the number of participants who chose 1-3 only.

  17. Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale.

    Time frame: 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)

    Patients' perceived improvement in UI symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I). PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse." Reported outcome measure is the number of participants that scored better (1, 2, or 3) at each time point. For improvement it was calculated the number of participants who chose 1-3 only.

  18. Number of Practices That Maintain a UI Management Intervention as Measured by the Practice Survey

    Time frame: 1 month post completion of each Wave's enrollment period (7 months from beginning of screening period of each Wave)

    Maintenance of UI management intervention will be assessed by practice survey completed by participant at the practice with indication of continuation for each intervention component.

  19. Number of Practices That Implement a UI Point Person as Measured by the Practice Survey

    Time frame: 1 month post completion of each Wave's enrollment period (7 months from beginning of screening for each Wave)

    Implementation of a UI point person will be measured as a percentage of sites answer yes on practice survey.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Empowering Women and Providers for Improved Care of Urinary Incontinence (UI) [EMPOWER Study]

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 25, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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