Urinary Incontinence
Conditions
Keywords
prostate cancer, urinary incontinence, pelvic floor muscle exercise, self-management, behavioral intervention, quality of life
Brief summary
This intervention program combines biofeedback PFME with a telephone or support group intervention to treat persistent urinary incontinence (UI). The study's primary aims are to improve continence, quality of life, and mood through enhancing adherence to PFME and self-management of incontinence symptoms. The secondary aims are to examine the physiological effects and cost effectiveness of the proposed interventions.
Detailed description
This is a randomized, controlled longitudinal study. Patients with early-stage prostate cancer and UI for more than six months were randomly assigned to one of three study arms: (1) biofeedback PFME plus a support group (BF+SUPPORT); (2) biofeedback PFME plus telephone (BF+PHONE); and (3) usual care (UC). The BF+SUPPORT and BF+PHONE participants learned PFME through computerized biofeedback. Thereafter, the BF+SUPPORT participants attended six group meetings and the BF+PHONE participants had six phone contacts every other week for three months. The UC participants did not receive biofeedback PFME or telephone/group intervention but continued receiving usual medical care. All subjects were assessed blind at baseline, 3 months (post intervention) and 6 months (follow-up). In addition, 49 moderately to severely incontinent patients were recruited from the three study groups to undergo urodynamic testing at baseline and 3 months for the evaluation of physiological changes. Data of the costs for the interventions and the participants' medical care were collected for a cost-effectiveness analysis.
Interventions
BEHAVIORALBF+SUPPORT
A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 group sessions of the Problem-Solving Therapy (teaching self-management skills).
BEHAVIORALBF+PHONE
A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 telephone sessions of the Problem-Solving Therapy (teaching self-management skills).
Sponsors
National Cancer Institute (NCI)
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A biobehavioral interveniton was tested
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have been diagnosed with early stage (I-III) prostate cancer. 2. Have completed cancer treatments six months prior. 3. Presence of incontinence symptoms
Exclusion criteria
1. Receiving hormonal treatment. 2. Urinary tract infection or urinary retention. 3. Cognitive impairment. 4. Having an implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Urinary Leakage | Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment | Amount of leakage measured on 1-hour pad test |
| Frequency of Daily Urinary Leakage | Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment | Average times of daily leakage measured on a 3-day diary |
Participant flow
Recruitment details
A randomized, controlled, longitudinal clinical trial was performed from 2010 to 2013 in Cleveland, Ohio
Participants by arm
| Arm | Count |
|---|---|
| BF+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 | 81 |
| 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 | 81 |
| Usual Care Subjects continued receiving usual care without receiving any intervention training sessions | 82 |
| Total | 244 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 10 | 13 | 12 |
Baseline characteristics
| Characteristic | BF+Support | BF+PHONE | Usual Care | Total |
|---|---|---|---|---|
| Age, Continuous | 66.8 years STANDARD_DEVIATION 7.2 | 64.3 years STANDARD_DEVIATION 7.3 | 64.9 years STANDARD_DEVIATION 8.2 | 65 years STANDARD_DEVIATION 7.6 |
| BMI | 28.3 kg/m^2 STANDARD_DEVIATION 4 | 29.3 kg/m^2 STANDARD_DEVIATION 5.7 | 29.2 kg/m^2 STANDARD_DEVIATION 5.4 | 28.8 kg/m^2 STANDARD_DEVIATION 5 |
| Cancer Stage Participants at stage III | 4 Participants | 5 Participants | 4 Participants | 13 Participants |
| Cancer Stage Participants at stage I or II | 77 Participants | 76 Participants | 78 Participants | 231 Participants |
| Charlson comorbidity index score | 0.63 score on a scale STANDARD_DEVIATION 1.1 | 0.78 score on a scale STANDARD_DEVIATION 1.1 | 0.95 score on a scale STANDARD_DEVIATION 1.8 | 0.78 score on a scale STANDARD_DEVIATION 1.4 |
| Education Colleage or higher | 27 Participants | 35 Participants | 28 Participants | 90 Participants |
| Education High school, associate degree | 46 Participants | 39 Participants | 47 Participants | 132 Participants |
| Education Less than high school | 8 Participants | 7 Participants | 7 Participants | 22 Participants |
| Employed | 28 Participants | 43 Participants | 36 Participants | 107 Participants |
| Marriat Status (Married) | 54 Participants | 52 Participants | 52 Participants | 158 Participants |
| PSA | 0.74 ng/mL STANDARD_DEVIATION 1.9 | 0.71 ng/mL STANDARD_DEVIATION 1.7 | 0.49 ng/mL STANDARD_DEVIATION 1.3 | 0.71 ng/mL STANDARD_DEVIATION 1.8 |
| Race (NIH/OMB) Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Asian | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Race Black or African American | 31 Participants | 26 Participants | 28 Participants | 85 Participants |
| Race (NIH/OMB) Race More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Race White | 49 Participants | 53 Participants | 51 Participants | 153 Participants |
| Received Radiation | 45 Participants | 43 Participants | 39 Participants | 127 Participants |
| Received Surgery | 43 Participants | 43 Participants | 47 Participants | 133 Participants |
| Sex: Female, Male Gender Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Gender Male | 81 Participants | 81 Participants | 82 Participants | 244 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 81 | 0 / 82 |
| other Total, other adverse events | 0 / 81 | 0 / 81 | 0 / 82 |
| serious Total, serious adverse events | 0 / 81 | 2 / 81 | 1 / 82 |
Outcome results
Primary
Amount of Urinary Leakage
Amount of leakage measured on 1-hour pad test
Time frame: Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment
Population: Data are reported only for those who completed the entire study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Amount of Urinary Leakage | T2 (3 month) | 11 grams | Standard Deviation 24.2 |
| Usual Care | Amount of Urinary Leakage | T1 (baseline) | 23.2 grams | Standard Deviation 48.4 |
| Usual Care | Amount of Urinary Leakage | T3 (6 month) | 14.2 grams | Standard Deviation 37.1 |
| BF+Telephone | Amount of Urinary Leakage | T2 (3 month) | 23.2 grams | Standard Deviation 73.5 |
| BF+Telephone | Amount of Urinary Leakage | T1 (baseline) | 22.3 grams | Standard Deviation 47.6 |
| BF+Telephone | Amount of Urinary Leakage | T3 (6 month) | 7.5 grams | Standard Deviation 21.8 |
| BF+Support | Amount of Urinary Leakage | T1 (baseline) | 31.5 grams | Standard Deviation 62.9 |
| BF+Support | Amount of Urinary Leakage | T3 (6 month) | 14.9 grams | Standard Deviation 40.1 |
| BF+Support | Amount of Urinary Leakage | T2 (3 month) | 17.9 grams | Standard Deviation 43.3 |
Primary
Frequency of Daily Urinary Leakage
Average times of daily leakage measured on a 3-day diary
Time frame: Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Frequency of Daily Urinary Leakage | T1 (baseline) | 3.2 Leaks per day | Standard Deviation 3.4 |
| Usual Care | Frequency of Daily Urinary Leakage | T2 (3 month) | 2.8 Leaks per day | Standard Deviation 3.4 |
| Usual Care | Frequency of Daily Urinary Leakage | T3 (6 month) | 2.5 Leaks per day | Standard Deviation 3 |
| BF+Telephone | Frequency of Daily Urinary Leakage | T1 (baseline) | 2.9 Leaks per day | Standard Deviation 3 |
| BF+Telephone | Frequency of Daily Urinary Leakage | T2 (3 month) | 1.8 Leaks per day | Standard Deviation 2.5 |
| BF+Telephone | Frequency of Daily Urinary Leakage | T3 (6 month) | 1.7 Leaks per day | Standard Deviation 2.7 |
| BF+Support | Frequency of Daily Urinary Leakage | T2 (3 month) | 1.7 Leaks per day | Standard Deviation 2.7 |
| BF+Support | Frequency of Daily Urinary Leakage | T3 (6 month) | 1.9 Leaks per day | Standard Deviation 3.3 |
| BF+Support | Frequency of Daily Urinary Leakage | T1 (baseline) | 2.7 Leaks per day | Standard Deviation 3.4 |