An Educational Video to Improve Patient Comprehension of Midurethral Sling

Felicia Lane

Status: Completed

Conditions: Stress Urinary Incontinence; Knowledge, Attitudes, Practice

Treatments: Other: Educational leaflet; Other: Educational video

Study type: Interventional

Funder types: Other

Identifiers

NCT03808974

20184707

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention group will be shown an educational video

Treatment:

Other: Educational video

Control

Active Comparator group

Description:

The control group will be given an educational leaflet

Treatment:

Other: Educational leaflet