An Educational Video to Improve Patient Comprehension of Midurethral Sling

NCT03808974 | Completed

• 1 other identifier: 20184707
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will be shown an educational video

Other: Educational video

Control

ACTIVE COMPARATOR

The control group will be given an educational leaflet

Other: Educational leaflet

Interventions

Educational video OTHER

Short educational video describing the mid-urethral sling procedure

Intervention

Educational leaflet OTHER

Standard educational leaflet describing the mid-urethral sling procedure

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women scheduled for a mid-urethral sling for stress urinary incontinence with a urogynecology provider at a participating hospital

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Felicia Lane: lead
• Kaiser Permanente: collaborator

Study Sites (1)

University of California, Irvine

Orange, California, 92628, United States

Location

Related Publications (1)

• 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.

  PMID: 35272337 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Behavior

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Felicia Lane, MD

  University of California, Irvine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Urogynecology Division Director

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 18, 2019
• Study Start: August 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: October 1, 2021
• Last Updated: September 19, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)