Trial Outcomes & Findings for Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance? (NCT NCT02875977)
NCT ID: NCT02875977
Last Updated: 2019-05-24
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
3 months
Results posted on
2019-05-24
Participant Flow
Patients were recruited from August 2016 through March 2017 (7 months) from a tertiary care female pelvic medicine and reconstructive surgery practice.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
58
|
71
|
|
Overall Study
NOT COMPLETED
|
42
|
29
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
42
|
29
|
Baseline Characteristics
Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?
Baseline characteristics by cohort
| Measure |
Experimental Counseling
n=100 Participants
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
n=100 Participants
Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.32 years
STANDARD_DEVIATION 16.12 • n=93 Participants
|
56.77 years
STANDARD_DEVIATION 17.00 • n=4 Participants
|
57.05 years
STANDARD_DEVIATION 16.52 • n=27 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=93 Participants
|
100 Participants
n=4 Participants
|
200 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
151 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=93 Participants
|
100 participants
n=4 Participants
|
200 participants
n=27 Participants
|
|
Body Mass Index
|
32.48 kg/m^2
STANDARD_DEVIATION 8.24 • n=93 Participants
|
29.94 kg/m^2
STANDARD_DEVIATION 6.74 • n=4 Participants
|
31.21 kg/m^2
STANDARD_DEVIATION 7.62 • n=27 Participants
|
|
Primary Language
English
|
95 Participants
n=93 Participants
|
94 Participants
n=4 Participants
|
189 Participants
n=27 Participants
|
|
Primary Language
Spanish
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Vaginal Parity
|
2 Pregnancies to a viable gestational age
n=93 Participants
|
2 Pregnancies to a viable gestational age
n=4 Participants
|
2 Pregnancies to a viable gestational age
n=27 Participants
|
|
Urogynecologic diagnosis
Stress Urinary Incontinence (SUI)
|
9 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Urogynecologic diagnosis
Urgency Urinary Incontinence (UUI)
|
25 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Urogynecologic diagnosis
Mixed Urinary Incontinence (MUI)
|
34 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Urogynecologic diagnosis
Urgency-frequency syndrome
|
27 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Urogynecologic diagnosis
Weak Pelvic Floor
|
8 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Urogynecologic diagnosis
Defecatory dysfunction
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Urogynecologic diagnosis
Pelvic Organ Prolapse (POP)
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Urogynecologic diagnosis
Myofascial Pain
|
40 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Urogynecologic diagnosis
Other Urogynecologic Diagnosis
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: This analysis comprises only the participants who were randomized and had follow-up PFPT completion information available
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
Outcome measures
| Measure |
Experimental Counseling
n=58 Participants
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
n=71 Participants
Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.
|
|---|---|---|
|
Number of Participants With Completed PT Visits
Completed half of the recommended visits
|
47 Participants
|
50 Participants
|
|
Number of Participants With Completed PT Visits
Did not complete half of the recommended visits
|
11 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: This analysis comprises all participants who were randomized
The number of patients who initiated PFPT is compared between those assigned to enhanced counseling versus standard counseling
Outcome measures
| Measure |
Experimental Counseling
n=100 Participants
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
n=100 Participants
Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.
|
|---|---|---|
|
Initiation of PFPT
Initiated PFPT
|
58 Participants
|
71 Participants
|
|
Initiation of PFPT
Did not initiate PFPT
|
42 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: This analysis comprises only the participants who were randomized and had follow-up PFPT completion information available
The number of patients who discharged from PFPT is compared between those assigned to enhanced counseling versus standard counseling
Outcome measures
| Measure |
Experimental Counseling
n=58 Participants
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
n=71 Participants
Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.
|
|---|---|---|
|
PFPT Discharge
PFPT discharge status unknown
|
2 Participants
|
1 Participants
|
|
PFPT Discharge
Discharged from PFPT
|
27 Participants
|
33 Participants
|
|
PFPT Discharge
Not discharged from PFPT
|
29 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: This analysis comprises only the participants who were randomized and initiated 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
Outcome measures
| Measure |
Experimental Counseling
n=58 Participants
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
n=71 Participants
Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.
|
|---|---|---|
|
Days to Initiation of PFPT
|
15 Days
Interval 7.0 to 23.0
|
19 Days
Interval 11.0 to 31.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: This analysis comprises only the participants who were randomized and had pre-PFPT and post-PFPT UDI-6 scores available
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.
Outcome measures
| Measure |
Experimental Counseling
n=27 Participants
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
n=24 Participants
Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.
|
|---|---|---|
|
Change in Urogenital Distress From Baseline to 3 Months
|
-12.04 units on a scale
Standard Deviation 21.29
|
-16.49 units on a scale
Standard Deviation 25.46
|
Adverse Events
Experimental Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cynthia Brincat, M.D., Ph.D.
Loyola University Medical Center
Phone: 708-216-2180
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place