CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Patient-Centered Counseling Video +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03198481
NCT03198481N/ACompleted

Protocol for Patient-Centered Versus Physician-Centered Counseling Video for Midurethral Slings an RCT

University of New Mexico·interventional·Posted Jun 26, 2017·Updated Dec 6, 2024

In Brief

A clinical study evaluating Patient-Centered Counseling Video and Physician Counseling Video for Stress Urinary Incontinence and Satisfaction. Completed, enrolled 70 participants across 2 sites.

Detailed Summary

The decision making process for stress incontinence surgery is complex. A key gap in the literature is how to improve patient preparedness and satisfaction for mid-urethral sling (MUS) surgery that is reproducible and low cost. Multimedia can assist in bridging this gap. The specific aims of the proposed research: (1) is to develop two videos to counsel patients who have elected to undergo a MUS surgery. One video will be created from a patient-centered perspective using peers as counselors. The second will employ a traditional counseling approach; (2) To compare the impact of multimedia counseling between women randomized to a patient-centered counseling versus a traditional counseling video. The investigators will recruit patients who present with stress urinary incontinence who elect to undergo a MUS procedure. Women will be randomized during their pre-operative visit to watch the patient-centered or traditional counseling video before they are counseled regarding their upcoming MUS surgery in the usual manner. The investigators anticipate women randomized to a patient centered-video will report higher satisfaction, less decisional regret, greater preparedness, and less anxiety as measured by validated scales. Successful completion will improve understanding of patient's needs and will allow development of improved educational tools readily available to the AUGS community.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 26, 2017
Enrollment StartJul 1, 2017
Primary CompletionFeb 28, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.0 years ago

Interventions

Patient-Centered Counseling Videobehavioral

Patients will watch a patient-centered education video regarding MUS prior to standard pre-operative counseling.

Physician Counseling Videobehavioral

Patients will watch a physician-centered video regarding MUS prior to standard pre-operative counseling.