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Patient-Centered Versus Physician-Centered Counseling MidUrethral Sling Videos (MUVi)

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ClinicalTrials.gov Identifier: NCT03198481
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of New Mexico

Brief 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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Satisfaction Behavioral: Patient-Centered Counseling Video Behavioral: Physician Counseling Video Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Protocol for Patient-Centered Versus Physician-Centered Counseling Video for Midurethral Slings an RCT
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Patient-Centered Counseling Video Group
MUS video utilizing a patient mentor.
Behavioral: Patient-Centered Counseling Video
Patients will watch a patient-centered education video regarding MUS prior to standard pre-operative counseling.

Active Comparator: Physician Counseling Video Group
MUS video by a physician.
Behavioral: Physician Counseling Video
Patients will watch a physician-centered video regarding MUS prior to standard pre-operative counseling.




Primary Outcome Measures :
  1. Patient preparedness [ Time Frame: Change from baseline at the 6 weeks post-operative visit ]
    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).


Secondary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: Change from baseline at the 6 weeks post-operative visit ]
    The objective is to compare patient satisfaction 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 satisfaction scores pre-operative and 6 weeks post-operative. Satisfaction will be measured by the Satisfaction with Decision Scale-Pelvic Floor Disorders (SDS-PFD) at her pre-operative visit and at the subjects 6 week visit.

  2. Decision Regret [ Time Frame: 6 weeks post-operative visit ]
    The objective is to compare patient decision regret between women in the patient-centered and physician centered video group. The investigators hypothesize that subjects in the patient-centered video group will report less decision regret at their 6 weeks post-operative visit. Decision regret will be evaluated using the Decision Regret Scale-Pelvic Floor Disorders (DRS-PFD) and at the subjects 6 week visit.


Other Outcome Measures:
  1. Patient Decisional Conflict [ Time Frame: Baseline ]
    To compare a women's decisional conflict pre-operatively in women randomized to the patient-centered and physician centered video using the Decisional Conflict Score (DCS) Questionnaire.

  2. Patient Anxiety [ Time Frame: Change from baseline at the 6 weeks post-operative visit ]
    To determine if there are differences in anxiety scores in women who watch the patient-centered video versus the physician centered video using the STAI: Y-6 questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198481


Locations
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United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87110
United States, Texas
Dell Medical School at University of Texas at Austin
Austin, Texas, United States, 78705
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Yuko M Komesu, MD University of New Mexico

Publications:

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Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT03198481     History of Changes
Other Study ID Numbers: 17-058
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of New Mexico:
midurethral sling
movie
preparedness
Video Counseling
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms