Patient-Centered Versus Physician-Centered Counseling MidUrethral Sling Videos

NCT03198481 | Completed

• 1 other identifier: 17-058
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Stress Urinary Incontinence; Satisfaction

Keywords

midurethral sling; movie; preparedness; Video Counseling

Outcome Measures

Primary Outcomes (1)

• Patient preparedness

  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).

  Change from baseline at the 6 weeks post-operative visit

Secondary Outcomes (2)

• Patient Satisfaction

  Change from baseline at the 6 weeks post-operative visit

• Decision Regret

  6 weeks post-operative visit

Other Outcomes (2)

• Patient Decisional Conflict

  Baseline

• Patient Anxiety

  Change from baseline at the 6 weeks post-operative visit

Study Arms (2)

Patient-Centered Counseling Video Group

ACTIVE COMPARATOR

MUS video utilizing a patient mentor.

Behavioral: Patient-Centered Counseling Video

Physician Counseling Video Group

ACTIVE COMPARATOR

MUS video by a physician.

Behavioral: Physician Counseling Video

Interventions

Patient-Centered Counseling Video BEHAVIORAL

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

Patient-Centered Counseling Video Group

Physician Counseling Video BEHAVIORAL

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

Physician Counseling Video Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are ≥ 18 years of age
• Planning to undergo a midurethral sling procedure
• Either stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with a positive cough stress test or SUI documented on urodynamic testing
• English speaking

You may not qualify if:

• Those who desire a concomitant POP Surgery
• Inability to speak/understand English
• Prior midurethral sling performed

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (2)

University of New Mexico

Albuquerque, New Mexico, 87110, United States

Location

Dell Medical School at University of Texas at Austin

Austin, Texas, 78705, United States

Location

Related Publications (12)

• Reading AE. Psychological preparation for surgery: patient recall of information. J Psychosom Res. 1981;25(1):57-62. doi: 10.1016/0022-3999(81)90084-2. No abstract available.

  PMID: 7277269 BACKGROUND

• Pool JJ. Expected and actual knowledge of hospital patients. Patient Couns Health Educ. 1980 3d Quart;2(3):111-7. doi: 10.1016/s0738-3991(80)80051-6. No abstract available.

  PMID: 10249187 BACKGROUND

• Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059.

  PMID: 18060968 BACKGROUND

• Brubaker L, Litman HJ, Rickey L, Dyer KY, Markland AD, Sirls L, Norton P, Casiano E, Paraiso MF, Ghetti C, Rahn DD, Kusek JW. Surgical preparation: are patients "ready" for stress urinary incontinence surgery? Int Urogynecol J. 2014 Jan;25(1):41-6. doi: 10.1007/s00192-013-2184-x. Epub 2013 Aug 3.

  PMID: 23912506 BACKGROUND

• Mancuso CA, Salvati EA, Johanson NA, Peterson MG, Charlson ME. Patients' expectations and satisfaction with total hip arthroplasty. J Arthroplasty. 1997 Jun;12(4):387-96. doi: 10.1016/s0883-5403(97)90194-7.

  PMID: 9195314 BACKGROUND

• Firoozi F, Gill B, Ingber MS, Moore CK, Rackley RR, Goldman HB, Vasavada SP. Increasing patient preparedness for sacral neuromodulation improves patient reported outcomes despite leaving objective measures of success unchanged. J Urol. 2013 Aug;190(2):594-7. doi: 10.1016/j.juro.2013.03.025. Epub 2013 Mar 14.

  PMID: 23499745 BACKGROUND

• Fultz NH, Burgio K, Diokno AC, Kinchen KS, Obenchain R, Bump RC. Burden of stress urinary incontinence for community-dwelling women. Am J Obstet Gynecol. 2003 Nov;189(5):1275-82. doi: 10.1067/s0002-9378(03)00598-2.

  PMID: 14634553 BACKGROUND

• Paraiso MF, Muir TW, Sokol AI. Are midurethral slings the gold standard surgical treatment for primary genuine stress incontinence? J Am Assoc Gynecol Laparosc. 2002 Nov;9(4):405-7. doi: 10.1016/s1074-3804(05)60510-5. No abstract available.

  PMID: 12386347 BACKGROUND

• McFadden BL, Constantine ML, Hammil SL, Tarr ME, Abed HT, Kenton KS, Sung VW, Rogers RG. Patient recall 6 weeks after surgical consent for midurethral sling using mesh. Int Urogynecol J. 2013 Dec;24(12):2099-104. doi: 10.1007/s00192-013-2136-5. Epub 2013 Jul 2.

  PMID: 23818127 BACKGROUND

• Dmochowski RR, Blaivas JM, Gormley EA, Juma S, Karram MM, Lightner DJ, Luber KM, Rovner ES, Staskin DR, Winters JC, Appell RA; Female Stress Urinary Incontinence Update Panel of the American Urological Association Education and Research, Inc; Whetter LE. Update of AUA guideline on the surgical management of female stress urinary incontinence. J Urol. 2010 May;183(5):1906-14. doi: 10.1016/j.juro.2010.02.2369. Epub 2010 Mar 29.

  PMID: 20303102 BACKGROUND

• Ellett L, Villegas R, Beischer A, Ong N, Maher P. Use of a multimedia module to aid the informed consent process in patients undergoing gynecologic laparoscopy for pelvic pain: randomized controlled trial. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):602-11. doi: 10.1016/j.jmig.2014.01.002. Epub 2014 Jan 23.

  PMID: 24462856 BACKGROUND

• Dawdy K, Bonin K, Russell S, Ryzynski A, Harth T, Townsend C, Liu S, Chu W, Cheung P, Chung H, Morton G, Vesprini D, Loblaw A, Cao X, Szumacher E. Developing and Evaluating Multimedia Patient Education Tools to Better Prepare Prostate-Cancer Patients for Radiotherapy Treatment (Randomized Study). J Cancer Educ. 2018 Jun;33(3):551-556. doi: 10.1007/s13187-016-1091-5.

  PMID: 27526692 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress; Personal Satisfaction

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; Behavior

Study Officials

• Yuko M Komesu, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 26, 2017
• Study Start: July 1, 2017
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)