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NCT03198481 · ClinicalTrials.gov registry record · NA
Patient-Centered Versus Physician-Centered Counseling MidUrethral Sling Videos
A NA study of Stress Urinary Incontinence and Satisfaction, sponsored by University of New Mexi.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 2
- Study locations
NCT03198481: Completed NA study of Stress Urinary Incontinence and Satisfaction, sponsored by University of New Mexi.
NCT03198481 is a NA study of Stress Urinary Incontinence and Satisfaction that has completed, run by University of New Mexi. The registered enrollment target is 70 participants, below the 161-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (57% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03198481, a NA study of Stress Urinary Incontinence and Satisfaction, has completed, sponsored by University of New Mexi.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The objective is to compare patient preparedness between women in the patient-centered and physician centered video group. The investigators hypothesize that subjects in the patient-centered video group will report higher preparedness pre-operative and 6 weeks post-operative on the Patient Preparedness Questionnaire (PPQ). The investigators will assess the level of pre-operative and post-operative preparedness according to each preparedness question on the Patient Preparedness Questionnaire (PPQ
Conditions Studied
Interventions
- BEHAVIORAL Patient-Centered Counseling Video
- BEHAVIORAL Physician Counseling Video
Study Locations (2)
New Mexico
- University of New Mexico - Albuquerque
Texas
- Dell Medical School at University of Texas at Austin - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2019-02-28 |
| Phase | NA |
What the finished NCT03198481 record still lists
NCT03198481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 161-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Patient-Centered Counseling Video is the first listed.
NCT03198481 reports a single indexed study location in New Mexico, Texas.
Frequently Asked Questions
What is clinical trial NCT03198481 about?
NCT03198481 is a clinical study titled "Patient-Centered Versus Physician-Centered Counseling MidUrethral Sling Videos". 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 pro...
What is the current status of trial NCT03198481?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2017-07-01. Estimated completion is 2019-02-28.
What conditions does trial NCT03198481 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence, Satisfaction.
What interventions are being tested in trial NCT03198481?
The interventions under investigation include: Patient-Centered Counseling Video (BEHAVIORAL), Physician Counseling Video (BEHAVIORAL).
Who is sponsoring clinical trial NCT03198481?
This trial is sponsored by University of New Mexi, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03198481 being conducted?
This trial has 2 study locations across New Mexico, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03198481's enrollment target sits among peer trials
70 24th of 35 higher than 11 of 35 other Stress Urinary Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress Urinary Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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