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Social Media Support for Urinary Incontinence (SNAK Trial)
N/A
Waitlist Available
Led By Tasha Serna-Gallegos, MD
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years old or older
Female
Must not have
Presence of urinary fistula
Cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 month
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effects of a Urogynecology Social Media Navigation Aid Kit (SNAK) vs routine counseling for treating urinary incontinence in women. Participants will be surveyed pre & post-intervention.
Who is the study for?
This trial is for women over 18 with urinary incontinence who are new to the Urogynecology practice at UNM or Sandoval Regional Medical Center. They must be experiencing their first treatment discussion, willing to fill out questionnaires, and have internet access. It's not for those under 18, with a history of treatments or consultations for incontinence, vaginal mesh issues, pregnancy plans soon, cognitive impairments, or language barriers.
What is being tested?
The study tests a Social Media Navigation Aid Kit (SNAK) against routine counseling for managing urinary incontinence symptoms. Women will either receive standard advice or this plus SNAK and then complete surveys about self-efficacy, satisfaction with treatment, symptom severity impact on quality of life and decision-making after three months.
What are the potential side effects?
Since the intervention involves social media tools and counseling rather than medication or surgery there may not be direct physical side effects; however participants might experience emotional distress or anxiety related to discussing personal health issues online.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am female.
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I experience involuntary loss of urine.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a urinary fistula.
Select...
I have difficulty with thinking or memory.
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I have been treated for urinary incontinence before.
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I cannot speak, read, or understand English.
Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient-Reported Outcomes Measurement Information System for Self-Efficacy in Managing Chronic Conditions- Managing Symptoms (PROMIS-SE-MCC-MS)
Secondary study objectives
IIQ-7-SF
Incontinence Severity Index (ISI)
Patient Global Impression of Improvement (PGI-I)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Routine counseling + Social Media Navigation Aid KitExperimental Treatment1 Intervention
Patients randomized to the intervention will receive routine counseling in the usual manner as well as receive access to the Social Media Navigation Aid Kit in the format of their choice (hardcopy via trifold, email, text, or QR code)
Group II: Routine counselingActive Control1 Intervention
Patients randomized to routine counseling will receive usual counseling in the standard fashion of their provider.
Find a Location
Who is running the clinical trial?
University of New MexicoLead Sponsor
388 Previous Clinical Trials
3,526,528 Total Patients Enrolled
12 Trials studying Urinary Incontinence
2,430 Patients Enrolled for Urinary Incontinence
Tasha Serna-Gallegos, MDPrincipal InvestigatorUniversity of New Mexico
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have internet access at home.I have a urinary fistula.I am 18 years old or older.I am female.I have difficulty with thinking or memory.I am willing to fill out study questionnaires.I am seeing a Urogynecologist at UNM or SRMC for urinary incontinence for the first time.I have been treated for urinary incontinence before.I have seen a specialist for bladder control issues.I cannot speak, read, or understand English.I experience involuntary loss of urine.I am under 18 years old.You have experienced problems with vaginal mesh in the past.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Routine counseling
- Group 2: Routine counseling + Social Media Navigation Aid Kit