An Educational Video to Improve Patient Comprehension of Midurethral Sling
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, Irvine | Orange | California | United States | 92628 |
Sponsors and Collaborators
- University of California, Irvine
- Kaiser Permanente
Investigators
- Principal Investigator: Bhumy D Heliker, MD, University of California, Irvine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-4707