An Educational Video to Improve Patient Comprehension of Midurethral Sling

The purpose of this research project is to test the effectiveness of a previsit educational video designed to help women understand the risks and benefits of a midurethral sling for treatment of stress urinary incontinence. A total of 38 participants will be recruited from both the Urogynecology pre-operative clinic of the university of California, Irvine Medical Center and the Urogynecology pre-operative clinic at Kaiser Permanente, Anaheim and Orange County. Participants will be randomized either to watch a 10 minute educational video (intervention group) or read a standard handout describing the midurethral sling (control group). Participants will then complete their pre-operative visit in the usual fashion. Participants will complete a pre- and post- intervention knowledge questionnaire to assess the primary outcome (change in knowledge before and after intervention). Participants will repeat the knowledge questionnaire and complete validated questionnaires for satisfaction with decision scale and decision regret at 2 and 6 weeks post-operative.

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence; Knowledge, Attitudes, Practice
• Intervention / Treatment: Other: Educational video; Other: Educational leaflet

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huynh, Phuong Linh Huynh; Phone Number: (714) 456-6155; Email: plhuynh@uci.edu

Study Locations

• United States
  • California
    • Orange, California, United States, 92628
      • Recruiting
      • University of California, Irvine
      • Contact: P Huynh; Phone Number: 714-456-6155; Email: plhuynh@hs.uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women scheduled for a mid-urethral sling for stress urinary incontinence with a urogynecology provider at a participating hospital

Exclusion Criteria:

• < 18 years of age
• Non-English speaking or requiring interpreter assistance
• Presence of cognitive dysfunction
• Women receiving a repeat midurethral sling (not primary)
• Women with a history of pelvic mesh complication (erosion, pain, history of mesh excision)
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention group will be shown an educational video	Other: Educational video; Short educational video describing the mid-urethral sling procedure
Active Comparator: Control; The control group will be given an educational leaflet	Other: Educational leaflet; Standard educational leaflet describing the mid-urethral sling procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient knowledge questionnaire (investigator-created)	The change in participant knowledge as measured with a patient knowledge questionnaire. This questionnaire was created by the study investigators and piloted by physicians within our institutions. It was submitted to and approved by our IRB for use in this study. This is a 15-point questionnaire (true/false/unknown answer choices) in which 1 point is given for each correct response and 0 points given for incorrect or unanswered questions (minimum score: 0/15, maximum score: 15/15). The questions pertain to the risks, benefits, and procedure of the mid-urethral sling surgery. Higher scores indicate better participant knowledge. A subscale of mesh-related questions will also be examined. This subscale reports the participant knowledge pertaining to complications and procedural knowledge specific to the use of mesh in the mid-urethral sling. The scale of this subset ranges from 0/5 to 5/5, with higher scores indicating greater participant knowledge.	6 weeks

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Kaiser Permanente
• Investigators: Principal Investigator: Bhumy D Heliker, MD, University of California, Irvine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: 2018-4707

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No