An Educational Video to Improve Patient Comprehension of Midurethral Sling

Not Applicable

• Conditions: Stress Urinary Incontinence; Knowledge, Attitudes, Practice
• Interventions: Other: Educational video; Other: Educational leaflet

• Registration Number: NCT03808974
• Lead Sponsor: University of California, Irvine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-18
• Study Start: 2019-08-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Educational video	The intervention group will be shown an educational video
Control	Educational leaflet	The control group will be given an educational leaflet

Primary Outcome Measures

Name	Time	Method
Patient knowledge questionnaire (investigator-created)	6 weeks	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.

Trial Locations

Locations (1)

University of California, Irvine; 🇺🇸 Orange, California, United States