Patient Compliance, Pelvic Floor Disorders
Conditions
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.
Detailed description
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.
Interventions
OTHEREducational video
A 4-minute educational video describing PFPT
OTHEREducational handout
A 2-page educational handout describing PFPT
Sponsors
Elizabeth Mueller
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
No masking is used in this study
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have prescribed PFPT by a treating physician in the Female Pelvic Medicine & Reconstructive Surgery practice
Exclusion criteria
* Patients ≤ 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Completed PT Visits | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of PFPT | 3 months | The number of patients who initiated PFPT is compared between those assigned to enhanced counseling versus standard counseling |
| PFPT Discharge | 3 months | The number of patients who discharged from PFPT is compared between those assigned to enhanced counseling versus standard counseling |
| Days to Initiation of PFPT | 3 months | The number of days from referral to PFPT to the first PFPT visit is compared between those assigned to enhanced counseling versus standard counseling |
| Change in Urogenital Distress From Baseline to 3 Months | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from August 2016 through March 2017 (7 months) from a tertiary care female pelvic medicine and reconstructive surgery practice.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| 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. | 100 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 42 | 29 |
Baseline characteristics
| Characteristic | Standard Counseling | Total | Experimental Counseling |
|---|---|---|---|
| Age, Continuous | 56.77 years STANDARD_DEVIATION 17 | 57.05 years STANDARD_DEVIATION 16.52 | 57.32 years STANDARD_DEVIATION 16.12 |
| Body Mass Index | 29.94 kg/m^2 STANDARD_DEVIATION 6.74 | 31.21 kg/m^2 STANDARD_DEVIATION 7.62 | 32.48 kg/m^2 STANDARD_DEVIATION 8.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 48 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 151 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Primary Language English | 94 Participants | 189 Participants | 95 Participants |
| Primary Language Spanish | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 28 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) White | 78 Participants | 159 Participants | 81 Participants |
| Region of Enrollment United States | 100 participants | 200 participants | 100 participants |
| Sex: Female, Male Female | 100 Participants | 200 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Urogynecologic diagnosis Defecatory dysfunction | 6 Participants | 12 Participants | 6 Participants |
| Urogynecologic diagnosis Mixed Urinary Incontinence (MUI) | 21 Participants | 55 Participants | 34 Participants |
| Urogynecologic diagnosis Myofascial Pain | 36 Participants | 76 Participants | 40 Participants |
| Urogynecologic diagnosis Other Urogynecologic Diagnosis | 2 Participants | 4 Participants | 2 Participants |
| Urogynecologic diagnosis Pelvic Organ Prolapse (POP) | 12 Participants | 22 Participants | 10 Participants |
| Urogynecologic diagnosis Stress Urinary Incontinence (SUI) | 25 Participants | 34 Participants | 9 Participants |
| Urogynecologic diagnosis Urgency-frequency syndrome | 20 Participants | 47 Participants | 27 Participants |
| Urogynecologic diagnosis Urgency Urinary Incontinence (UUI) | 24 Participants | 49 Participants | 25 Participants |
| Urogynecologic diagnosis Weak Pelvic Floor | 14 Participants | 22 Participants | 8 Participants |
| Vaginal Parity | 2 Pregnancies to a viable gestational age | 2 Pregnancies to a viable gestational age | 2 Pregnancies to a viable gestational age |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
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
Time frame: 3 months
Population: This analysis comprises only the participants who were randomized and had follow-up PFPT completion information available
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Counseling | Number of Participants With Completed PT Visits | Completed half of the recommended visits | 47 Participants |
| Experimental Counseling | Number of Participants With Completed PT Visits | Did not complete half of the recommended visits | 11 Participants |
| Standard Counseling | Number of Participants With Completed PT Visits | Completed half of the recommended visits | 50 Participants |
| Standard Counseling | Number of Participants With Completed PT Visits | Did not complete half of the recommended visits | 21 Participants |
Comparison: The null hypothesis is that there is no difference in the odds of completing half of the recommended PFPT visits between those assigned to standard versus experimental counselingp-value: 0.1795% CI: [0.782, 4.119]Regression, Logistic
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.
Time frame: 3 months
Population: This analysis comprises only the participants who were randomized and had pre-PFPT and post-PFPT UDI-6 scores available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Counseling | Change in Urogenital Distress From Baseline to 3 Months | -12.04 units on a scale | Standard Deviation 21.29 |
| Standard Counseling | Change in Urogenital Distress From Baseline to 3 Months | -16.49 units on a scale | Standard Deviation 25.46 |
Comparison: The null hypothesis is that there is no difference in the change from pre-PFPT to post-PFPT UDI-6 scores between those assigned to standard versus experimental counselingp-value: 0.595% CI: [-17.6149, 8.7028]t-test, 2 sided
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
Time frame: 3 months
Population: This analysis comprises only the participants who were randomized and initiated PFPT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental Counseling | Days to Initiation of PFPT | 15 Days |
| Standard Counseling | Days to Initiation of PFPT | 19 Days |
Comparison: Among those who initiated PFPT therapy, the null hypothesis is that there is no difference in the number of days to initiating PFPT therapy between those assigned to standard versus experimental counselingp-value: 0.16Wilcoxon (Mann-Whitney)
Secondary
Initiation of PFPT
The number of patients who initiated PFPT is compared between those assigned to enhanced counseling versus standard counseling
Time frame: 3 months
Population: This analysis comprises all participants who were randomized
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Counseling | Initiation of PFPT | Initiated PFPT | 58 Participants |
| Experimental Counseling | Initiation of PFPT | Did not initiate PFPT | 42 Participants |
| Standard Counseling | Initiation of PFPT | Initiated PFPT | 71 Participants |
| Standard Counseling | Initiation of PFPT | Did not initiate PFPT | 29 Participants |
Comparison: The null hypothesis is that there is no difference in the odds of initiating PFPT between those assigned to standard versus experimental counselingp-value: 0.05695% CI: [0.314, 1.014]Regression, Logistic
Secondary
PFPT Discharge
The number of patients who discharged from PFPT is compared between those assigned to enhanced counseling versus standard counseling
Time frame: 3 months
Population: This analysis comprises only the participants who were randomized and had follow-up PFPT completion information available
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Counseling | PFPT Discharge | Discharged from PFPT | 27 Participants |
| Experimental Counseling | PFPT Discharge | Not discharged from PFPT | 29 Participants |
| Experimental Counseling | PFPT Discharge | PFPT discharge status unknown | 2 Participants |
| Standard Counseling | PFPT Discharge | Discharged from PFPT | 33 Participants |
| Standard Counseling | PFPT Discharge | Not discharged from PFPT | 37 Participants |
| Standard Counseling | PFPT Discharge | PFPT discharge status unknown | 1 Participants |
Comparison: The null hypothesis is that there is no difference in the odds of discharge from PFPT between those assigned to standard versus experimental counselingp-value: 0.995% CI: [0.517, 2.11]Regression, Logistic