search
Back to results

An Educational Video to Improve Patient Comprehension of Midurethral Sling

Primary Purpose

Stress Urinary Incontinence, Knowledge, Attitudes, Practice

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational video
Educational leaflet
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of California, IrvineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

The intervention group will be shown an educational video

The control group will be given an educational leaflet

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2019
Last Updated
December 16, 2020
Sponsor
University of California, Irvine
Collaborators
Kaiser Permanente
search

1. Study Identification

Unique Protocol Identification Number
NCT03808974
Brief Title
An Educational Video to Improve Patient Comprehension of Midurethral Sling
Official Title
An Educational Video to Improve Patient Comprehension of Midurethral Sling
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Irvine
Collaborators
Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Knowledge, Attitudes, Practice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group will be shown an educational video
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group will be given an educational leaflet
Intervention Type
Other
Intervention Name(s)
Educational video
Intervention Description
Short educational video describing the mid-urethral sling procedure
Intervention Type
Other
Intervention Name(s)
Educational leaflet
Intervention Description
Standard educational leaflet describing the mid-urethral sling procedure
Primary Outcome Measure Information:
Title
Patient knowledge questionnaire (investigator-created)
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huynh, Phuong Linh Huynh
Phone
(714) 456-6155
Email
plhuynh@uci.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhumy D Heliker, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92628
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P Huynh
Phone
714-456-6155
Email
plhuynh@hs.uci.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35272337
Citation
Jeney SES, Whitcomb EL, Ihara J, Guaderrama N, Mukhtar F, Heliker BD. A Randomized Controlled Trial Evaluating the Effect of an Educational Video on Patient Understanding of Midurethral Sling. Female Pelvic Med Reconstr Surg. 2022 Mar 1;28(3):e73-e79. doi: 10.1097/SPV.0000000000001154.
Results Reference
derived

Learn more about this trial

An Educational Video to Improve Patient Comprehension of Midurethral Sling

We'll reach out to this number within 24 hrs