Social Media Navigation Aid Kits for Urinary Incontinence

NCT05858125 | Completed

• 1 other identifier: 23-083
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

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. 1.evaluate the impact of SNAK on patients' self-efficacy in managing urinary incontinence symptoms
2. 2.compare patient satisfaction with urinary incontinence treatment between SNAK and routine counseling groups
3. 3.assess the impact of SNAK on urinary incontinence severity
4. 4.evaluate the impact of SNAK on patients' quality of life
5. 5.examine if there is an impact of SNAK on patients' treatment decision.

Conditions

Urinary Incontinence; Stress Incontinence, Female; Urge Incontinence

Keywords

urinary incontinence; social media

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient Global Impression of Improvement (PGI-I)

  3 month

• Incontinence Severity Index (ISI)

  3 month

• IIQ-7-SF

  3 months

Study Arms (2)

Routine counseling

NO INTERVENTION

Patients randomized to routine counseling will receive usual counseling in the standard fashion of their provider.

Routine counseling + Social Media Navigation Aid Kit

EXPERIMENTAL

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)

Other: Social Media Navigation Aid Kit

Interventions

Social Media Navigation Aid Kit OTHER

The Social media Navigation Aid Kit (SNAK) was created by using search terms, "urinary incontinence", "urinary leakage", and "urogynecology", and querying various websites/blogs, Facebook, Instagram, and YouTube. These social media platforms were chosen based on the top three social media platforms used in Americans aged 50 to \>65 years old according to Pew Research Analytics (Pew paper). The experienced reviewer evaluated each platform for users that provided relevant, accurate, and specific content. The department of Urogynecology at UNM independently reviewed the curated pages and users for approval. Once approved, the various users and pages were then collected and a flyer was created. The flyer will be available via hardcopy, email, or text per patient preference.

Routine counseling + Social Media Navigation Aid Kit

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (2)

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Sandoval Regional Medical Center

Rio Rancho, New Mexico, 87144, United States

Location

Related Publications (23)

• Patel UJ, Godecker AL, Giles DL, Brown HW. Updated Prevalence of Urinary Incontinence in Women: 2015-2018 National Population-Based Survey Data. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):181-187. doi: 10.1097/SPV.0000000000001127. Epub 2022 Jan 12.

  PMID: 35030139 BACKGROUND

• Bennett AT, Boniface ER, Spiers A, Gregory WT, Cichowski SB. A Randomized Trial of Social Media Versus Search Engine Advertising to Increase Awareness of Treatments for Female Stress Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2022 May 1;28(5):293-299. doi: 10.1097/SPV.0000000000001187. Epub 2022 Apr 15.

  PMID: 35421015 BACKGROUND

• Mazloomdoost D, Kanter G, Chan RC, Deveaneau N, Wyman AM, Von Bargen EC, Chaudhry Z, Elshatanoufy S, Miranne JM, Chu CM, Pauls RN, Arya LA, Antosh DD. Social networking and Internet use among pelvic floor patients: a multicenter survey. Am J Obstet Gynecol. 2016 Nov;215(5):654.e1-654.e10. doi: 10.1016/j.ajog.2016.06.011. Epub 2016 Jun 16.

  PMID: 27319368 BACKGROUND

• Gonzalez G, Vaculik K, Khalil C, Zektser Y, Arnold C, Almario CV, Spiegel BMR, Anger JT. Women's Experience with Stress Urinary Incontinence: Insights from Social Media Analytics. J Urol. 2020 May;203(5):962-968. doi: 10.1097/JU.0000000000000706. Epub 2019 Dec 19.

  PMID: 31855097 BACKGROUND

• Qin LA, El-Neemany D, Winkler H, Shalom D. #Urogyn: What's Trending on Instagram? A Cross-sectional Observational Study. Female Pelvic Med Reconstr Surg. 2020 May;26(5):283-286. doi: 10.1097/SPV.0000000000000869.

  PMID: 32282524 BACKGROUND

• Grabbert M, Khoder WY, Gratzke C, Paffenholz P, Salem J, Bauer RM. Comprehensive analysis of Twitter activity on #Incontinence. Neurourol Urodyn. 2020 Jan;39(1):440-446. doi: 10.1002/nau.24227. Epub 2019 Nov 20.

  PMID: 31746478 BACKGROUND

• Weinstein MM, Collins S, Quiroz L, Anger JT, Paraiso MFR, DeLong J, Richter HE. Multicenter Randomized Controlled Trial of Pelvic Floor Muscle Training with a Motion-based Digital Therapeutic Device versus Pelvic Floor Muscle Training Alone for Treatment of Stress-predominant Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2022 Jan 1;28(1):1-6. doi: 10.1097/SPV.0000000000001052.

  PMID: 33787561 BACKGROUND

• Nystrom E, Soderstrom L, Samuelsson E. Self-management of incontinence using a free mobile app: factors associated with improvement. Int Urogynecol J. 2022 Apr;33(4):877-885. doi: 10.1007/s00192-021-04755-5. Epub 2021 Apr 7.

  PMID: 33825925 BACKGROUND

• Schroeder M, Plotner EA, Sharma S, Hunter K, Spector S, Lipetskaia L. A Randomized Controlled Trial of a Multimedia Patient Education Tool for Stress Versus Urgency Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):403-408. doi: 10.1097/SPV.0000000000000946.

  PMID: 32925421 BACKGROUND

• Jeney SES, Whitcomb EL, Ihara J, Guaderrama N, Mukhtar F, Heliker BD. A Randomized Controlled Trial Evaluating the Effect of an Educational Video on Patient Understanding of Midurethral Sling. Female Pelvic Med Reconstr Surg. 2022 Mar 1;28(3):e73-e79. doi: 10.1097/SPV.0000000000001154.

  PMID: 35272337 BACKGROUND

• Svengalis, S., Nygaard, I. E., Cervone, D., & Kreder, K. J. (1995). Perceived self-efficacy as a predictor of outcome of pelvic muscle exercises in the treatment of urinary incontinence. International urogynecology journal, 6(5), 262-266.

  BACKGROUND

• Broome BA. The impact of urinary incontinence on self-efficacy and quality of life. Health Qual Life Outcomes. 2003 Aug 22;1:35. doi: 10.1186/1477-7525-1-35.

  PMID: 12969511 BACKGROUND

• White LL, Cohen MZ, Berger AM, Kupzyk KA, Bierman PJ. Self-Efficacy for Management of Symptoms and Symptom Distress in Adults With Cancer: An Integrative Review. Oncol Nurs Forum. 2019 Jan 13;46(1):113-128. doi: 10.1188/19.ONF.113-128.

  PMID: 30547965 BACKGROUND

• Messer KL, Hines SH, Raghunathan TE, Seng JS, Diokno AC, Sampselle CM. Self-efficacy as a predictor to PFMT adherence in a prevention of urinary incontinence clinical trial. Health Educ Behav. 2007 Dec;34(6):942-52. doi: 10.1177/1090198106295399. Epub 2007 Apr 24.

  PMID: 17456856 BACKGROUND

• Tannenbaum C, Brouillette J, Michaud J, Korner-Bitensky N, Dumoulin C, Corcos J, Tu le M, Lemieux MC, Ouellet S, Valiquette L. Responsiveness and clinical utility of the geriatric self-efficacy index for urinary incontinence. J Am Geriatr Soc. 2009 Mar;57(3):470-5. doi: 10.1111/j.1532-5415.2008.02146.x. Epub 2009 Jan 23.

  PMID: 19187418 BACKGROUND

• Kot D, Lawinski M, Slodkowski M, Kagan I, Hellerman M, Theilla M. Effects of Sexual Function, Social Media Use, and Self-Efficacy on Quality of Life Among Home Parenteral Nutrition Patients. JPEN J Parenter Enteral Nutr. 2021 Jul;45(5):991-998. doi: 10.1002/jpen.1969. Epub 2020 Aug 5.

  PMID: 32700380 BACKGROUND

• Niu Z, Willoughby J, Zhou R. Associations of Health Literacy, Social Media Use, and Self-Efficacy With Health Information-Seeking Intentions Among Social Media Users in China: Cross-sectional Survey. J Med Internet Res. 2021 Feb 25;23(2):e19134. doi: 10.2196/19134.

  PMID: 33629955 BACKGROUND

• Mahmood QK, Jafree SR, Mukhtar S, Fischer F. Social Media Use, Self-Efficacy, Perceived Threat, and Preventive Behavior in Times of COVID-19: Results of a Cross-Sectional Study in Pakistan. Front Psychol. 2021 Jun 17;12:562042. doi: 10.3389/fpsyg.2021.562042. eCollection 2021.

  PMID: 34220597 BACKGROUND

• Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

  PMID: 20685078 BACKGROUND

• Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS(R) measures of self-efficacy for managing chronic conditions. Qual Life Res. 2017 Jul;26(7):1915-1924. doi: 10.1007/s11136-017-1527-3. Epub 2017 Feb 26.

  PMID: 28239781 BACKGROUND

• Schagen van Leeuwen JH, Lange RR, Jonasson AF, Chen WJ, Viktrup L. Efficacy and safety of duloxetine in elderly women with stress urinary incontinence or stress-predominant mixed urinary incontinence. Maturitas. 2008 Jun 20;60(2):138-47. doi: 10.1016/j.maturitas.2008.04.012. Epub 2008 Jun 10.

  PMID: 18547757 BACKGROUND

• Sandvik H, Espuna M, Hunskaar S. Validity of the incontinence severity index: comparison with pad-weighing tests. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Sep;17(5):520-4. doi: 10.1007/s00192-005-0060-z. Epub 2006 Mar 18.

  PMID: 16547687 BACKGROUND

• Terwee CB, Peipert JD, Chapman R, Lai JS, Terluin B, Cella D, Griffiths P, Mokkink LB. Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures. Qual Life Res. 2021 Oct;30(10):2729-2754. doi: 10.1007/s11136-021-02925-y. Epub 2021 Jul 10.

  PMID: 34247326 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

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

Study Officials

• Tasha Serna-Gallegos, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 15, 2023
• Study Start: April 24, 2023
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)