Urinary Incontinence Clinical Trial
— SNAKOfficial title:
Social Media Navigation Aid Kits for Urinary Incontinence
NCT number | NCT05858125 |
Other study ID # | 23-083 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 24, 2023 |
Est. completion date | May 2025 |
This study aims to compare the effectiveness of a Urogynecology Social Media Navigation Aid Kit (SNAK) and routine counseling in the treatment of women with newly diagnosed urinary incontinence. The study will conduct a randomized controlled trial on treatment-naïve patients seeking care for urinary incontinence. The research will have five aims: 1. evaluate the impact of SNAK on patients' self-efficacy in managing urinary incontinence symptoms 2. compare patient satisfaction with urinary incontinence treatment between SNAK and routine counseling groups 3. assess the impact of SNAK on urinary incontinence severity 4. evaluate the impact of SNAK on patients' quality of life 5. examine if there is an impact of SNAK on patients' treatment decision. Participants will be randomized to routine counseling alone versus routine counseling plus a SNAK. They will be given a baseline survey at their initial enrollment to the study. The investigators will follow up at a 3-month interval where they will be given a post-intervention survey.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | May 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - New or existing patients to the Urogynecology practice at the University of New Mexico or Sandoval Regional Medical Center having urinary incontinence treatment options discussed/addressed by our provider group for the first time. - Patients who report symptoms of urinary incontinence (defined as one or more episodes of involuntary urinary loss) - Female - >18 years old - Willing to complete study questionnaires Exclusion Criteria: - Age < 18 years - Presence of urinary fistula - Prior treatment of urinary incontinence - Prior consult with a urogynecologist for urinary incontinence - History of vaginal mesh complications - Pregnancy or planning to become pregnant in the next 3-4 months during the study per patient report - Cognitive impairment - No access to internet at home - Inability to speak/read/understand English |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico | Albuquerque | New Mexico |
United States | Sandoval Regional Medical Center | Rio Rancho | New Mexico |
Lead Sponsor | Collaborator |
---|---|
University of New Mexico |
United States,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient-Reported Outcomes Measurement Information System for Self-Efficacy in Managing Chronic Conditions- Managing Symptoms (PROMIS-SE-MCC-MS) | We will measure self-efficacy using the NIH Patient-Reported Outcomes Measurement Information System for Self-Efficacy in Managing Chronic Conditions- Managing Symptoms (PROMIS-SE-MCC-MS). The PROMIS raw scores are translated into a "T-score", which rescales and standardizes the score where the mean U.S. general population score is fixed at 50 points and SD fixed at 10. | 3 month | |
Secondary | Patient Global Impression of Improvement (PGI-I) | The Patient Global Impression of Improvement (PGI-I) is a validated 1-item questionnaire rating specific condition as perceived change in her condition in response to therapy for SUI. A lower score indicates better outcome. | 3 month | |
Secondary | Incontinence Severity Index (ISI) | The Incontinence Severity Index is a validated questionnaire that has been shown to correlate well with pad weighing tests. A lower index score at 3 months indicates clinical improvement/better outcome. | 3 month | |
Secondary | IIQ-7-SF | The Incontinence Impact Questionnaire is a validated questionnaire to assess the impact of the dysfunction on a patient quality of life. A lower IIQ-7-SF score at 3 months indicates better outcome/improvement. | 3 months |
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