An Educational Video to Improve Patient Comprehension of Midurethral Sling

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

Tracking Information

• First Submitted Date: January 15, 2019
• First Posted Date: January 18, 2019
• Last Update Posted Date: December 17, 2020
• Actual Study Start Date: August 1, 2019
• Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 17, 2019)

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.

Original Primary Outcome Measures (submitted: January 15, 2019)

Patient knowledge questionnaire [ Time Frame: 6 weeks ]

Change in knowledge as measured with a patient knowledge questionnaire

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Educational Video to Improve Patient Comprehension of Midurethral Sling
• Official Title: An Educational Video to Improve Patient Comprehension of Midurethral Sling
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Care Provider); Primary Purpose: Treatment

Condition

• Stress Urinary Incontinence
• Knowledge, Attitudes, Practice

Intervention

• Other: Educational video
  Short educational video describing the mid-urethral sling procedure
• Other: Educational leaflet
  Standard educational leaflet describing the mid-urethral sling procedure

Study Arms

• Experimental: Intervention
  The intervention group will be shown an educational video
  Intervention: Other: Educational video
• Active Comparator: Control
  The control group will be given an educational leaflet
  Intervention: Other: Educational leaflet

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 15, 2019): 38
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2022
• Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03808974
• Other Study ID Numbers: 2018-4707
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of California, Irvine
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, Irvine
• Original Study Sponsor: Same as current
• Collaborators: Kaiser Permanente

Investigators

• Principal Investigator: Bhumy D Heliker, MD; University of California, Irvine

• PRS Account: University of California, Irvine
• Verification Date: December 2020