An Educational Video to Improve Patient Comprehension of Midurethral Sling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Stress Urinary Incontinence Knowledge, Attitudes, Practice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Intervention

The intervention group will be shown an educational video

Group Type EXPERIMENTAL

Educational video

Intervention Type OTHER

Short educational video describing the mid-urethral sling procedure

Control

The control group will be given an educational leaflet

Group Type ACTIVE_COMPARATOR

Educational leaflet

Intervention Type OTHER

Standard educational leaflet describing the mid-urethral sling procedure

Interventions

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Educational video

Short educational video describing the mid-urethral sling procedure

Intervention Type OTHER

Educational leaflet

Standard educational leaflet describing the mid-urethral sling procedure

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No