The objective of this research is to perform a non-masked, superiority randomized
controlled trial to assess urinary incontinence (UI) symptoms of women newly diagnosed
with UI before and after conservative treatment with either a Urogynecology Social Media
Navigation Aid Kit or routine counseling. The target population are treatment naïve
patients with urinary incontinence who are seeking care as a new patient. Our central
hypothesis is that the addition of a Urogynecology Social Media Navigation Aid Kit will
be superior to routine counseling alone in women with urinary incontinence.
The investigators will recruit women with any type of urinary incontinence who present to
the University of New Mexico Urogynecology practice at UNM Eubank Clinic (UNM) or
Sandoval Regional Medical Center (SRMC). To confirm diagnosis and eligibility, The
investigators will conduct a standard intake history and physical, complete with cough
stress test, POP-Q pelvic examination, urinalysis, and urine culture. All potential
participants will receive routine counseling about possible treatment options appropriate
for her urinary incontinence, regardless of group assignment. Their follow up
appointments will be the same regardless of participation in the study.
The intervention is a Social media Navigation Aid Kit (SNAK) which 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 an infographic was created. The infographic will be available via hardcopy (as a
trifold), email, text, and/or via QR code per patient preference.
Potential subjects will be recruited in the UNM Eubank and SRMC clinics when they present
for care for OAB/UUI, either in person or virtually via telephone or Zoom care visits.
All patients will have a history and physical taken to determine their study eligibility.
Recruitment will take place either in private exam rooms at these clinics or over
HIPAA-compliant telephone or Zoom conversation. After recruitment, they will undergo the
informed consent via the same means as recruitment and complete initial questionnaires in
clinic or will be sent a copy (digital or mail) to read if enrolled virtually.
The randomization sequence will be generated by computer-based randomization in a
sequence that preserves 1:1 randomization and also preserves allocation concealment
(likely with randomly alternating block sizes of 6-10 in blocked randomization).
Randomization assignments will be completed via REDCAP by a research coordinator.
Randomization will only occur after consent has been signed and all baseline data has
been obtained.
This is a single-center study at the University of New Mexico, and this site will recruit
up to 75 patients.
Outcomes collected:
Data will be collected prospectively using a series of surveys. Our primary aim is to
determine whether the participants have improved self-efficacy following the intervention
based on the PROMIS Self-Efficacy for Managing Symptoms questionnaire at 3 months. The
target population will be patients with urinary incontinence who are seeking care. If a
patient is interested in this and fulfills study inclusion criteria then The
investigators will offer her the choice of volunteering for the study. All women will
give consent prior to their enrollment, after they have had time to carefully consider
whether they want to participate in the study. Research staff and clinicians will obtain
consent either in clinic or via zoom. After enrollment, participants will fill out
baseline surveys including: Incontinence Severity Index (ISI), Patient-Reported Outcomes
Measurement Information System for Managing Chronic Conditions- Managing Symptoms
(PROMIS-SE-MCC-MS), Incontinence Impact Questionnaire (IIQ-7-SF).
At 3 months, patients will fill out the following surveys: ISI, PROMIS-SE-MCC-MS, PGI-I,
IIQ-7-SF, and 3-month follow up questionnaire. If unable to contact the patient 3 times,
The investigators will discontinue attempts and the patient will be considered lost to
follow up.
Data Analysis:
Power analysis was performed based on previously reported minimally important change
(MIC) of 2-6 points for PROMIS measures (26). The investigators will use the MIC of 2
points, divided by the expected SD of 10 points, giving us an effect size of 0.2. In
order to examine the extent to which the score improves depending on the study arm
assignment, repeated-measures ANOVA was used. To achieve significance for a
non-inferiority study using these assumptions the investigators would need 50 patients,
25 per group to detect this difference with alpha =0.05 and with 80% power. To allow for
a dropout of 20% the investigators will enroll at least 50 patients, but up to 75 to
account for participants who are lost to follow up.
Between and within group differences will be evaluated using Fisher's exact test for
categorical variables and t-tests for continuous variables, as the investigators expect
the data will be normally distributed. Wilcoxon rank-sum test will be used for continuous
variables that are not normally distributed. If there are any baseline differences
between groups, a multivariate analysis will determine the contribution of these
differences to observed differences (if any) between groups
Data Management/Confidentiality:
Participants will be given a de-identified study subject number. Data collection sheets
and questionnaires will contain the subject number. No other patient identifiers will be
collected on study forms. PHI including patient name, date of birth, phone number, email
address and medical record number will be collected to track appointments and ensure
patient follow-up. The data collection, HIPAA and consent forms will be maintained via
REDCap. PHI will not be entered into the study database. The link between PHI and study
IDs will be kept on a password protected computer on a secure UNM OBGYN department
server.
The study database does not include sensitive information or information requiring
additional protection.
Electronic data entry will be performed on REDCAP, using the de-identified subject study
number. The electronic data and subject link will be encrypted, password protected, and
stored on the secure UNM OBGYN department server. This server's electronic security is
monitored / maintained by the Health Sciences Library and Informatics Center (HSLIC). A
REDCAP database will be created to collect, store and manage the data. REDCAP databases
are reposed securely and all data entered is de-identified. The REDCAP database is only
accessible using an individual unique login and password and access is only provided to
co-investigators. Access is restricted to co-investigators and research staff and will be
protected using the unique REDCAP login and password provided to each co-investigator.
Access to the REDCAP will be restricted to research personnel and Investigators and will
be locked or password-protected using the unique REDCAP login and password provided to
each co-investigator. The data will be stored for 6 years after completion of analysis
and study closure and then will be destroyed.
A Certificate of Confidentiality will not be used to protect data from forced release. No
identifying or study related data will be transported to outside locations. There will be
no audio or video recordings or photographs taken.
