Trial Outcomes & Findings for Improving Urinary Continence and Quality of Life in Prostate Cancer Patients (NCT NCT01365182)
NCT ID: NCT01365182
Last Updated: 2022-10-12
Results Overview
Amount of leakage measured on 1-hour pad test
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
279 participants
Primary outcome timeframe
Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment
Results posted on
2022-10-12
Participant Flow
A randomized, controlled, longitudinal clinical trial was performed from 2010 to 2013 in Cleveland, Ohio
Participant milestones
| Measure |
BE+Support
a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly peer support group sessions during 3 months to learn symptom self- management skills
|
BF+PHONE
a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly individual telephone contact with a therapist during 3 months to learn symptom self- management skills
|
Usual Care
Subjects continued receiving usual care without receiving any intervention training sessions
|
|---|---|---|---|
|
Overall Study
STARTED
|
91
|
94
|
94
|
|
Overall Study
COMPLETED
|
81
|
81
|
82
|
|
Overall Study
NOT COMPLETED
|
10
|
13
|
12
|
Reasons for withdrawal
| Measure |
BE+Support
a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly peer support group sessions during 3 months to learn symptom self- management skills
|
BF+PHONE
a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly individual telephone contact with a therapist during 3 months to learn symptom self- management skills
|
Usual Care
Subjects continued receiving usual care without receiving any intervention training sessions
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
13
|
12
|
Baseline Characteristics
Each row represents a study arm/ group. Total participants from three study arms =244 (overall number of participants)
Baseline characteristics by cohort
| Measure |
BF+Support
n=81 Participants
a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly peer support group sessions during 3 months to learn symptom self- management skills
|
BF+PHONE
n=81 Participants
a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly individual telephone contact with a therapist during 3 months to learn symptom self- management skills
|
Usual Care
n=82 Participants
Subjects continued receiving usual care without receiving any intervention training sessions
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
64.9 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
65 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
|
Sex: Female, Male
Gender · Female
|
0 Participants
n=5 Participants • Each row represents a study arm/ group. Total participants from three study arms =244 (overall number of participants)
|
0 Participants
n=7 Participants • Each row represents a study arm/ group. Total participants from three study arms =244 (overall number of participants)
|
0 Participants
n=5 Participants • Each row represents a study arm/ group. Total participants from three study arms =244 (overall number of participants)
|
0 Participants
n=4 Participants • Each row represents a study arm/ group. Total participants from three study arms =244 (overall number of participants)
|
|
Sex: Female, Male
Gender · Male
|
81 Participants
n=5 Participants • Each row represents a study arm/ group. Total participants from three study arms =244 (overall number of participants)
|
81 Participants
n=7 Participants • Each row represents a study arm/ group. Total participants from three study arms =244 (overall number of participants)
|
82 Participants
n=5 Participants • Each row represents a study arm/ group. Total participants from three study arms =244 (overall number of participants)
|
244 Participants
n=4 Participants • Each row represents a study arm/ group. Total participants from three study arms =244 (overall number of participants)
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
0 Participants
n=7 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
0 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
0 Participants
n=4 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
|
Race (NIH/OMB)
Race · Asian
|
0 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
1 Participants
n=7 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
1 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
2 Participants
n=4 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
0 Participants
n=7 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
0 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
0 Participants
n=4 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
|
Race (NIH/OMB)
Race · Black or African American
|
31 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
26 Participants
n=7 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
28 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
85 Participants
n=4 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
|
Race (NIH/OMB)
Race · White
|
49 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
53 Participants
n=7 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
51 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
153 Participants
n=4 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
|
Race (NIH/OMB)
Race · More than one race
|
0 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
0 Participants
n=7 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
0 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
0 Participants
n=4 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
1 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
1 Participants
n=7 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
2 Participants
n=5 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
4 Participants
n=4 Participants • row 1 = overall (n=244) row 2-3: each row represents a study arm/ group
|
|
Marriat Status (Married)
|
54 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
|
Education
Colleage or higher
|
27 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Education
High school, associate degree
|
46 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Education
Less than high school
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Employed
|
28 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Cancer Stage
Participants at stage I or II
|
77 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
231 Participants
n=4 Participants
|
|
Cancer Stage
Participants at stage III
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Received Surgery
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Received Radiation
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
|
BMI
|
28.3 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
29.3 kg/m^2
STANDARD_DEVIATION 5.7 • n=7 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 5 • n=4 Participants
|
|
PSA
|
0.74 ng/mL
STANDARD_DEVIATION 1.9 • n=5 Participants
|
0.71 ng/mL
STANDARD_DEVIATION 1.7 • n=7 Participants
|
0.49 ng/mL
STANDARD_DEVIATION 1.3 • n=5 Participants
|
0.71 ng/mL
STANDARD_DEVIATION 1.8 • n=4 Participants
|
|
Charlson comorbidity index score
|
0.63 score on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
0.78 score on a scale
STANDARD_DEVIATION 1.1 • n=7 Participants
|
0.95 score on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
0.78 score on a scale
STANDARD_DEVIATION 1.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessmentPopulation: Data are reported only for those who completed the entire study.
Amount of leakage measured on 1-hour pad test
Outcome measures
| Measure |
Usual Care
n=70 Participants
Subjects continued receiving usual care without receiving any intervention training sessions
|
BF+Telephone
n=62 Participants
a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly individual telephone contact with a therapist during 3 months to learn symptom self- management skills
|
BF+Support
n=67 Participants
a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly peer support group sessions during 3 months to learn symptom self- management skills
|
|---|---|---|---|
|
Amount of Urinary Leakage
T3 (6 month)
|
14.2 grams
Standard Deviation 37.1
|
7.5 grams
Standard Deviation 21.8
|
14.9 grams
Standard Deviation 40.1
|
|
Amount of Urinary Leakage
T1 (baseline)
|
23.2 grams
Standard Deviation 48.4
|
22.3 grams
Standard Deviation 47.6
|
31.5 grams
Standard Deviation 62.9
|
|
Amount of Urinary Leakage
T2 (3 month)
|
11 grams
Standard Deviation 24.2
|
23.2 grams
Standard Deviation 73.5
|
17.9 grams
Standard Deviation 43.3
|
PRIMARY outcome
Timeframe: Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessmentPopulation: Data are reported only for those who completed this measure at all three assessment points. Subjects that did not complete this measure three times were not included.
Average times of daily leakage measured on a 3-day diary
Outcome measures
| Measure |
Usual Care
n=55 Participants
Subjects continued receiving usual care without receiving any intervention training sessions
|
BF+Telephone
n=49 Participants
a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly individual telephone contact with a therapist during 3 months to learn symptom self- management skills
|
BF+Support
n=54 Participants
a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly peer support group sessions during 3 months to learn symptom self- management skills
|
|---|---|---|---|
|
Frequency of Daily Urinary Leakage
T1 (baseline)
|
3.2 Leaks per day
Standard Deviation 3.4
|
2.9 Leaks per day
Standard Deviation 3.0
|
2.7 Leaks per day
Standard Deviation 3.4
|
|
Frequency of Daily Urinary Leakage
T2 (3 month)
|
2.8 Leaks per day
Standard Deviation 3.4
|
1.8 Leaks per day
Standard Deviation 2.5
|
1.7 Leaks per day
Standard Deviation 2.7
|
|
Frequency of Daily Urinary Leakage
T3 (6 month)
|
2.5 Leaks per day
Standard Deviation 3.0
|
1.7 Leaks per day
Standard Deviation 2.7
|
1.9 Leaks per day
Standard Deviation 3.3
|
Adverse Events
BF+Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BF+PHONE
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BF+Support
n=81 participants at risk
a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly peer support group sessions during 3 months to learn symptom self- management skills
|
BF+PHONE
n=81 participants at risk
a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly individual telephone contact with a therapist during 3 months to learn symptom self- management skills
|
Usual Care
n=82 participants at risk
Subjects continued receiving usual care without receiving any intervention training sessions
|
|---|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/81 • 7 months (study duration)
This is a behavioral study and has a low risk for study subjects. All participants' charts are reviewed and adverse events are reported.
|
1.2%
1/81 • Number of events 1 • 7 months (study duration)
This is a behavioral study and has a low risk for study subjects. All participants' charts are reviewed and adverse events are reported.
|
1.2%
1/82 • Number of events 1 • 7 months (study duration)
This is a behavioral study and has a low risk for study subjects. All participants' charts are reviewed and adverse events are reported.
|
|
General disorders
Fall
|
0.00%
0/81 • 7 months (study duration)
This is a behavioral study and has a low risk for study subjects. All participants' charts are reviewed and adverse events are reported.
|
1.2%
1/81 • Number of events 1 • 7 months (study duration)
This is a behavioral study and has a low risk for study subjects. All participants' charts are reviewed and adverse events are reported.
|
0.00%
0/82 • 7 months (study duration)
This is a behavioral study and has a low risk for study subjects. All participants' charts are reviewed and adverse events are reported.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place