Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?

NCT02875977 | Completed Results

• 1 other identifier: 208990
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators intend to measure compliance with attending pelvic floor physical therapy (PFPT) in a Urogynecology population by randomizing patients to either viewing a four minute educational video or reading a handout explaining the therapy.

Conditions

Patient Compliance; Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Completed PT Visits

  The number of patients who completed at least half of their recommended PFPT visits is compared between those assigned to enhanced counseling versus standard counseling

  3 months

Secondary Outcomes (4)

• Initiation of PFPT

  3 months

• PFPT Discharge

  3 months

• Days to Initiation of PFPT

  3 months

• Change in Urogenital Distress From Baseline to 3 Months

  3 months

Study Arms (2)

Experimental Counseling

EXPERIMENTAL

Patients randomized to this arm receive experimental counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout and a 4-minute educational video.

Other: Educational video; Other: Educational handout

Standard Counseling

ACTIVE COMPARATOR

Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.

Other: Educational handout

Interventions

Educational video OTHER

A 4-minute educational video describing PFPT

Experimental Counseling

Educational handout OTHER

A 2-page educational handout describing PFPT

Experimental Counseling; Standard Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have prescribed PFPT by a treating physician in the Female Pelvic Medicine \& Reconstructive Surgery practice

You may not qualify if:

• Patients ≤ 18 years old

Sponsors & Collaborators

• Elizabeth Mueller: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (5)

• Dumoulin C, Alewijnse D, Bo K, Hagen S, Stark D, Van Kampen M, Herbert J, Hay-Smith J, Frawley H, McClurg D, Dean S. Pelvic-Floor-Muscle Training Adherence: Tools, Measurements and Strategies-2011 ICS State-of-the-Science Seminar Research Paper II of IV. Neurourol Urodyn. 2015 Sep;34(7):615-21. doi: 10.1002/nau.22794. Epub 2015 May 21.

  PMID: 25998493 BACKGROUND

• Fitzgerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2013 Jan;189(1 Suppl):S75-85. doi: 10.1016/j.juro.2012.11.018.

  PMID: 23234638 BACKGROUND

• Alewijnse D, Mesters I, Metsemakers J, Adriaans J, van den Borne B. Predictors of intention to adhere to physiotherapy among women with urinary incontinence. Health Educ Res. 2001 Apr;16(2):173-86. doi: 10.1093/her/16.2.173.

  PMID: 11345660 BACKGROUND

• Tibaek S, Dehlendorff C. Do women with pelvic floor dysfunction referred by gynaecologists and urologists at hospitals complete a pelvic floor muscle training programme? A retrospective study, 1992-2008. Int Urogynecol J. 2013 Aug;24(8):1361-9. doi: 10.1007/s00192-012-2018-2. Epub 2013 Jan 5.

  PMID: 23291858 BACKGROUND

• Shannon MB, Adams W, Fitzgerald CM, Mueller ER, Brubaker L, Brincat C. Does Patient Education Augment Pelvic Floor Physical Therapy Preparedness and Attendance? A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2018 Mar/Apr;24(2):155-160. doi: 10.1097/SPV.0000000000000516.

  PMID: 29474290 DERIVED

MeSH Terms

Conditions

Patient Compliance; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Limitations and Caveats

There are no limitations or caveats to report

Results Point of Contact

• Title: Cynthia Brincat, M.D., Ph.D.
• Organization: Loyola University Medical Center

cbrincat@lumc.edu

708-216-2180

Study Officials

• Cynthia Brincat, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

• Elizabeth Mueller, MD

  Loyola University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is used in this study
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Associate Professor

Model Details: Participants are randomized to standard counseling for pelvic floor physical therapy (PFPT) or to an experimental counseling group that comprises both standard counseling and a 4-minute PFPT educational video using a 1:1 allocation

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: August 3, 2016
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: May 24, 2019
• Results First Posted: September 27, 2018

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)