Patient-Centered Versus Physician-Centered Counseling MidUrethral Sling Videos



Status:Recruiting
Conditions:Urology, Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:9/27/2017
Start Date:July 1, 2017
End Date:June 28, 2019
Contact:Tessa E Krantz, MD
Email:tkrantz@salud.unm.edu
Phone:5053800979

Use our guide to learn which trials are right for you!

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

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.

Management of Pelvic Floor Disorders (PFDs) is individualized according to a patient's
symptomatology and quality of life. Although conservative measures exist, patients may elect
for surgical management. The decision making process for surgery is complex. It is well
documented that patient's lack understanding prior to their surgical procedures. Preparedness
for MUS surgery is related to a patient's comprehension of the purpose, risks, benefits, and
complications. Patients who are more prepared prior to surgery have been proven to have
greater postoperative satisfaction. Therefore, it is essential to improve patients'
preparedness and enhance patients' understanding of realistic expectations of post-operative
outcomes.

The investigators long-term goal is to improve patient-centered preparedness and satisfaction
when considering surgery. Previous studies by the Preliminary Study of Peer Support Groups
and Pelvic Floor Disorders have demonstrated trends in improvement for preparedness and
decision conflict with the use of peer focus groups. However, peer support groups are a
costly process and there may be many barriers to participation.

A key gap in the literature is how to improve patient preparedness for surgery and improve
satisfaction through the use of peer counseling in a manner that is convenient for patients,
reproducible and low cost. Technological advances with multimedia may assist in bridging this
gap. With ease-of-access to mobile electronic devices, videos are effective tools to prepare
patients for surgery. The purpose of this randomized controlled clinical trial is to
determine if a patient-centered video improves satisfaction and preparedness compared to a
physician-centered video.

The first objective of this research is to develop two videos to counsel patients who have
elected to undergo a MUS procedure. One video will be created from a physician-centered
approach. The second video will be a patient-centered perspective. The second objective of
this research is to compare the impact of video counseling between women randomized to a
physician-centered versus a patient-centered video. The central hypothesis is that women
randomized to a patient-centered video will report higher scores of satisfaction and
preparedness than women randomized to the physician-centered video.

Specifically, our aims for this study are:

1. To create two videos to be used to counsel patients who have elected to undergo a MUS
procedure. One video will present the risks, benefits and alternatives to MUS surgery by
a physician, mimicking traditional counseling prior to surgery. The second video will
explain the risks, benefits and alternatives to the MUS surgery utilizing a patient
mentor who has undergone the MUS procedure and will describe the patients' perception of
the information. The patient-centered video will also include topics that have
previously been identified by focus groups as important patient-centered aspects of
pre-surgical counseling.

2. To compare the impact of video counseling between women randomized to a
physician-centered video and a patient-centered video. Hypothesis: Women randomized to a
patient centered-video will report higher satisfaction and preparedness as measured by
validated scales. They will have higher scores on the Post-operative preparedness
questionnaire (PPQ), Preparedness Scale and the Surgical Decision Satisfaction (SDS-PFD)
questionnaire; and lower scores on the Decision Regret Scale (DRS-PFD) questionnaire
than women randomized to view the physician-centered video prior to undergoing
mid-urethral sling surgery.

3. To compare a women's decisional conflict post-operatively in women randomized to the
physician-centered video and the patient-centered video. Hypothesis: There is a
reduction of decisional conflict in women randomized to the patient-centered video.

4. To determine if there are differences in anxiety scores in women who watch the
patient-centered video versus the physician centered video. Hypothesis: Anxiety scores
measured by the State Trait Anxiety Inventory (STAI: Y-6 Item) questionnaire are
decreased by a pre-operative patient-centered counseling video.

Inclusion Criteria:

1. Subjects are ≥ 18 years of age

2. Planning to undergo a midurethral sling procedure

3. Either stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with a
positive cough stress test or SUI documented on urodynamic testing

4. English speaking

Exclusion Criteria:

1. Those who desire a concomitant POP Surgery

2. Inability to speak/understand English

3. Prior midurethral sling performed
We found this trial at
2
sites
Albuquerque, New Mexico 87131
(505) 277-0111
Phone: 505-967-8428
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
1601 Trinity Street
Austin, Texas 78705
Principal Investigator: Amanda White, MD
Phone: 318-332-5614
?
mi
from
Austin, TX
Click here to add this to my saved trials