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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.
Patients who have been interviewed, examined, and a plan has been made by the treating physicians in the Female Pelvic Medicine & Reconstructive Surgery practice will be invited to participate at the end of the visit if the patient and physician mutually agree that PFPT is the treatment modality to pursue.
If she agrees to participate, she will be consented and randomized. If she is randomized to standard counseling, she will be given the standard handout to read. If she is randomized to the intervention, she will receive the standard handout and view the 4-minute educational video on an iPad.
At the conclusion of the counseling, patients will be asked if they have any additional questions, and these will be recorded and answered. The patient will also fill out a visual analog scale about how informed she feels regarding PFPT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational video | Other | A 4-minute educational video describing PFPT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Initiation of PFPT | The number of patients who initiated PFPT is compared between those assigned to enhanced counseling versus standard counseling | 3 months |
| PFPT Discharge | The number of patients who discharged from PFPT is compared between those assigned to enhanced counseling versus standard counseling |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Brincat, MD | Loyola University | Principal Investigator |
| Elizabeth Mueller, MD | Loyola University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25998493 | Background | 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. | |
| 23234638 |
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There is no plan to share individual participant data with other researchers
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Patients were recruited from August 2016 through March 2017 (7 months) from a tertiary care female pelvic medicine and reconstructive surgery practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Counseling | Patients randomized to this arm receive experimental counseling on the importance of attending pelvic floor physical therapy (PFPT) appointments. This includes the standard 2-page educational handout and a 4-minute educational video. |
| FG001 | Standard Counseling | Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Counseling | 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. |
| BG001 | Standard Counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | This analysis comprises only the participants who were randomized and had follow-up PFPT completion information available | Posted | Count of Participants | Participants | 3 months |
|
Adverse event data were collected for 11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Counseling | 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. |
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There are no limitations or caveats to report
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Brincat, M.D., Ph.D. | Loyola University Medical Center | 708-216-2180 | cbrincat@lumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2016 | Dec 25, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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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
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No masking is used in this study
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| Educational handout |
| Other |
A 2-page educational handout describing PFPT |
|
| 3 months |
| Days to Initiation of PFPT | The number of days from referral to PFPT to the first PFPT visit is compared between those assigned to enhanced counseling versus standard counseling | 3 months |
| Change in Urogenital Distress From Baseline to 3 Months | Patients complete the Urinary Distress Inventory 6 (UDI-6) prior to beginning PFPT therapy and following PFPT therapy. The change in UDI-6 from baseline to 3 months following therapy is compared between those assigned to enhanced counseling versus standard counseling. The UDI-6 is an assessment of urogenital distress with a score range from 0 to 100, where higher scores indicate greater disability. | 3 months |
| 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. |
| 11345660 | 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. |
| 23291858 | 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. |
| 29474290 | Derived | 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. |
Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Primary Language | Count of Participants | Participants |
|
| Vaginal Parity | Median | Inter-Quartile Range | Pregnancies to a viable gestational age |
|
| Urogynecologic diagnosis | Count of Participants | Participants |
|
Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.
|
|
|
| Secondary | Initiation of PFPT | The number of patients who initiated PFPT is compared between those assigned to enhanced counseling versus standard counseling | This analysis comprises all participants who were randomized | Posted | Count of Participants | Participants | 3 months |
|
|
|
|
| Secondary | PFPT Discharge | The number of patients who discharged from PFPT is compared between those assigned to enhanced counseling versus standard counseling | This analysis comprises only the participants who were randomized and had follow-up PFPT completion information available | Posted | Count of Participants | Participants | 3 months |
|
|
|
|
| Secondary | Days to Initiation of PFPT | The number of days from referral to PFPT to the first PFPT visit is compared between those assigned to enhanced counseling versus standard counseling | This analysis comprises only the participants who were randomized and initiated PFPT | Posted | Median | Inter-Quartile Range | Days | 3 months |
|
|
|
|
| Secondary | Change in Urogenital Distress From Baseline to 3 Months | Patients complete the Urinary Distress Inventory 6 (UDI-6) prior to beginning PFPT therapy and following PFPT therapy. The change in UDI-6 from baseline to 3 months following therapy is compared between those assigned to enhanced counseling versus standard counseling. The UDI-6 is an assessment of urogenital distress with a score range from 0 to 100, where higher scores indicate greater disability. | This analysis comprises only the participants who were randomized and had pre-PFPT and post-PFPT UDI-6 scores available | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Standard Counseling | Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout. | 0 | 100 | 0 | 100 | 0 | 100 |
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| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
| PFPT discharge status unknown |
|