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An Educational Video to Improve Patient Comprehension of Midurethral Sling

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ClinicalTrials.gov Identifier: NCT03808974
Recruitment Status : Unknown
Verified December 2020 by University of California, Irvine.
Recruitment status was:  Recruiting
First Posted : January 18, 2019
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
University of California, Irvine

Study Description
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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
Stress Urinary Incontinence Knowledge, Attitudes, Practice Other: Educational video Other: Educational leaflet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: An Educational Video to Improve Patient Comprehension of Midurethral Sling
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Patient knowledge questionnaire (investigator-created) [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808974


Contacts
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Contact: Huynh, Phuong Linh Huynh (714) 456-6155 plhuynh@uci.edu

Locations
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United States, California
University of California, Irvine Recruiting
Orange, California, United States, 92628
Contact: P Huynh    714-456-6155    plhuynh@hs.uci.edu   
Sponsors and Collaborators
University of California, Irvine
Kaiser Permanente
Investigators
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Principal Investigator: Bhumy D Heliker, MD University of California, Irvine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT03808974    
Other Study ID Numbers: 2018-4707
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations