An Educational Video to Improve Patient Comprehension of Midurethral Sling

Stress Urinary Incontinence Clinical Trial

Official title:

An Educational Video to Improve Patient Comprehension of Midurethral Sling

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03808974
• Other study ID #: 2018-4707
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 2022

Study information

• Verified date: December 2020
• Source: University of California, Irvine
• Contact: Huynh, Phuong Linh Huynh
• Phone: (714) 456-6155
• Email: plhuynh[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knowledge, Attitudes, Practice
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Educational video
Short educational video describing the mid-urethral sling procedure
• Educational leaflet
Standard educational leaflet describing the mid-urethral sling procedure

Locations

Country	Name	City	State
United States	University of California, Irvine	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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