Prostate Cancer, Urinary Incontinence
Conditions
Keywords
radical prostatectomy, urinary incontinence, prostate cancer, telehealth, pelvic floor muscle training
Brief summary
Many men develop urine leakage after prostate cancer surgery. Usually it is temporary, but pelvic floor muscle training and exercise (including urine control strategies) have been shown to reduce the time to regaining urine control. This study tests an evidence-based, pelvic floor muscle training program that has been adapted to telehealth format and pilot tested in a VA-funded pilot/developmental trial. Training is begun 1-4 weeks before surgery and continued 6 months after surgery. Content is accessed on a secure website in daily 10-minute sessions which transition to weekly sessions for post-operative months 3-6. In the investigators' pilot study, Veterans reported that they appreciated receiving the training in the privacy of their homes, enjoyed the interactive style of the learning experience, and felt better prepared to deal with urine leakage and empowered with new knowledge and skills to help themselves. Content for both control and treatment groups includes general information about prostate cancer; perioperative care; wetness, odor and skin care management. The treatment group will ALSO receive pelvic floor muscle training and bladder control strategies. Outcomes are measured with brief validated questions administered by the telehealth platform, and again at 9 and 12 months by mailed questionnaire or the telehealth platform.
Detailed description
Many men develop urine leakage after radical prostatectomy. Usually it is temporary, but pelvic floor muscle training including bladder control strategies has been shown to reduce the severity of incontinence and reduce the time to regaining continence. This study will test an evidence-based pelvic floor muscle training program that has been adapted to telehealth format and pilot tested in a VA-funded pilot/developmental trial. Training is begun 1-4 weeks before surgery and continued 6 months after surgery. Content is accessed on a secure website in daily 10-minute sessions which transition to weekly sessions for post-operative months 3-6. In the investigators' pilot study, Veterans reported that they appreciated receiving the training in the privacy of their homes, enjoyed the interactive style of the learning experience, and felt better prepared to deal with urine leakage and empowered with new knowledge and skills to help themselves. This study is a randomized, controlled trial of the telehealth-delivered, evidence-based, intervention developed in the pilot/developmental study. Participants will be randomized 1:1 to treatment or to a control group. Content for both control and treatment groups includes general information about prostate cancer; perioperative care; wetness, odor and skin care management. The treatment group will ALSO receive pelvic floor muscle training and bladder control strategies. Outcomes are measured with brief validated questions administered by the telehealth platform, and again at 9 and 12 months by mailed questionnaire or the telehealth platform.
Interventions
Evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 2-4 weeks before surgery and continued 2 months after surgery. Content is accessed in daily 10-minute sessions on a secure website
Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.
Sponsors
Study design
Eligibility
Inclusion criteria
* Scheduled to undergo a radical prostatectomy for treatment of prostate cancer and enrolled at the Birmingham, Philadelphia, or Atlanta VA Medical Centers or the affiliated University Medical Centers * Ability to read English. * Internet access
Exclusion criteria
* Urinary Incontinence in the 6 months prior to prostate cancer surgery (other than post-void dribbling) * Less than 1 week before surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Continence | 6 months | Time to continence was based on the time point at which participants reported no urinary incontinence on the International Consultation on Incontinence (ICI) Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). ICIQ-UI SF is one of a series of ICI questionnaires that have been meticulously developed and tested. The ICIQ-UI SF is a brief (4 items), reliable (Cronbach's alpha = 0.95), questionnaire that quantifies both symptom burden and impact of incontinence and has been validated in men and women. It was administered weekly during the 6 months after surgery. Scores range from 0-21; higher scores indicate worse condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI) | 6 months, 9 months, 12 months | This measure, validated as a stand-alone assessment, consists of 4 questions from the full Expanded Prostate Cancer Index (EPIC), a health-related quality of life assessment tool. The EPIC was developed based on advice from an expert panel and prostate cancer survivors, expanding the 20-item University of California - Los Angeles Prostate Cancer Index. Scores range from 0-100; higher scores indicate worse condition. |
| Incontinence Impact Questionnaire - Short Form (IIQ-SF) | 6 months, 9 months, 12 months | This measure, validated in men with post-prostatectomy incontinence, measures the impact of incontinence on regular activities. It is a condition-specific quality of life measure that has been widely used in incontinence clinical trials. There are seven items. Response options are: not at all, slightly, moderately, greatly. Scores range from 0-100; higher scores indicate greater impact. |
| International Prostate Symptom Scale - Quality of Life Question | 6 months, 9 months, 12 months | Validated single question: If you were to spend the rest of your life with your urinary problem the way it is now, how would you feel about that? Response options: delighted, pleased, mostly satisfied, mixed (about equally satisfied and dissatisfied), mostly dissatisfied, unhappy, terrible. |
| Patient Satisfaction Question (PSQ) | 6 months, 9 months, 12 months | Patient's rating of satisfaction (Completely satisfied, Somewhat satisfied, Not at all satisfied) |
| Estimated Percent Improvement (EPI) | 6 months, 9 months, 12 months | Participant self-report of perceived percent improvement from 0% to 100% |
| International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score | 6 months, 9 months, 12 months | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form total score. Scores range from 0-21; higher scores indicate worse condition. |
| How Disturbing is Urine Leakage | 6 months, 9 months, 12 months | Single quality of life question: How disturbing is the urine leakage problem to you? (not at all, somewhat, or extremely disturbing) |
| Activity Restriction | 6 months, 9 months, 12 months | Single quality of life question: How much does leakage of urine restrict your activities? (not at all, some of the time, most of the time, all of the time). |
| Return to Work | 6 months, 9 months, 12 months | Single quality of life question: Have you been able to return to work since your surgery? (yes, no, retired or disabled) |
| Resumption of Normal Activity | 6 months, 9 months, 12 months | Single quality of life question: Have you been able to resume your usual activities since your surgery? (yes, no) |
| Global Perception of Improvement (GPI) | 6 months, 9 months, 12 months | Participant's global perception of their improvement (Much better, Better, About the same, Worse, Much worse) |
Countries
United States
Participant flow
Recruitment details
245 participants were enrolled in the trial, but only 197 received the assigned intervention. 9 did not have the planned prostatectomy; 39 never started the assigned intervention.
Participants by arm
| Arm | Count |
|---|---|
| Telehealth With Pelvic Floor Muscle Training Participants in this group will participate in an evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively. In addition to the pelvic floor muscle training, content will also include general perioperative care; wetness, odor and skin care management; and outcome measures.
Pelvic Floor Muscle Training: Evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in daily 10-minute sessions on a secure website
Perioperative Care and Wetness Management: Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively. | 122 |
| Telehealth Without Pelvic Floor Muscle Training Participants in this group will receive a telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.
Perioperative Care and Wetness Management: Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively. | 123 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | lost computer access | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 7 |
| Overall Study | Withdrawal by Subject | 8 | 2 |
Baseline characteristics
| Characteristic | Telehealth With Pelvic Floor Muscle Training | Total | Telehealth Without Pelvic Floor Muscle Training |
|---|---|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 7.8 | 61.7 years STANDARD_DEVIATION 7.4 | 61.7 years STANDARD_DEVIATION 7.1 |
| Anxiety Missing | 1 Participants | 1 Participants | 0 Participants |
| Anxiety No | 111 Participants | 213 Participants | 102 Participants |
| Anxiety Yes | 10 Participants | 31 Participants | 21 Participants |
| Asthma, COPD No | 108 Participants | 221 Participants | 113 Participants |
| Asthma, COPD Yes | 14 Participants | 24 Participants | 10 Participants |
| Body mass index | 28.2 kg/m^2 STANDARD_DEVIATION 4.61 | 28.9 kg/m^2 STANDARD_DEVIATION 4.6 | 29.6 kg/m^2 STANDARD_DEVIATION 4.54 |
| Degenerative disc disease Don't know | 1 Participants | 1 Participants | 0 Participants |
| Degenerative disc disease No | 103 Participants | 199 Participants | 96 Participants |
| Degenerative disc disease Yes | 18 Participants | 45 Participants | 27 Participants |
| Depression No | 103 Participants | 205 Participants | 102 Participants |
| Depression Yes | 19 Participants | 40 Participants | 21 Participants |
| Diabetes No | 98 Participants | 207 Participants | 109 Participants |
| Diabetes Yes | 24 Participants | 38 Participants | 14 Participants |
| Education College or beyond | 82 Participants | 167 Participants | 85 Participants |
| Education < High school | 1 Participants | 3 Participants | 2 Participants |
| Education HS or GED | 39 Participants | 75 Participants | 36 Participants |
| Employment Employed | 69 Participants | 144 Participants | 75 Participants |
| Employment Retired, disabled, or unemployed | 53 Participants | 101 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 122 Participants | 243 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gleason score < 7 | 32 Participants | 68 Participants | 36 Participants |
| Gleason score > or =7 | 90 Participants | 177 Participants | 87 Participants |
| Heart failure No | 121 Participants | 241 Participants | 120 Participants |
| Heart failure Yes | 1 Participants | 4 Participants | 3 Participants |
| Living situation Live alone | 14 Participants | 24 Participants | 10 Participants |
| Living situation Live with family | 104 Participants | 213 Participants | 109 Participants |
| Living situation Other | 4 Participants | 8 Participants | 4 Participants |
| Neurological disease No | 119 Participants | 239 Participants | 120 Participants |
| Neurological disease Yes | 3 Participants | 6 Participants | 3 Participants |
| Neurovascular bundle sparing Both spared | 93 Participants | 192 Participants | 99 Participants |
| Neurovascular bundle sparing Missing | 14 Participants | 30 Participants | 16 Participants |
| Neurovascular bundle sparing None spared | 7 Participants | 11 Participants | 4 Participants |
| Neurovascular bundle sparing One spared | 8 Participants | 12 Participants | 4 Participants |
| Prostate specific antigen (PSA), ng/mL < 10 | 3 Participants | 11 Participants | 8 Participants |
| Prostate specific antigen (PSA), ng/mL > or +10 | 119 Participants | 234 Participants | 115 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 65 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 82 Participants | 177 Participants | 95 Participants |
| Region of Enrollment United States | 122 participants | 245 participants | 123 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 122 Participants | 245 Participants | 123 Participants |
| Smoking status Current smoker | 14 Participants | 23 Participants | 9 Participants |
| Smoking status Former smoker | 46 Participants | 88 Participants | 42 Participants |
| Smoking status Never smoked | 62 Participants | 134 Participants | 72 Participants |
| Stroke or TIA No | 117 Participants | 238 Participants | 121 Participants |
| Stroke or TIA Yes | 5 Participants | 7 Participants | 2 Participants |
| Surgical approach Missing | 12 Participants | 22 Participants | 10 Participants |
| Surgical approach Perineal | 8 Participants | 24 Participants | 16 Participants |
| Surgical approach Retropubic | 102 Participants | 199 Participants | 97 Participants |
| Surgical technique Missing | 11 Participants | 19 Participants | 8 Participants |
| Surgical technique Open | 5 Participants | 9 Participants | 4 Participants |
| Surgical technique Robotic | 106 Participants | 217 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 1 / 96 |
| other Total, other adverse events | 0 / 101 | 1 / 96 |
| serious Total, serious adverse events | 0 / 101 | 1 / 96 |
Outcome results
Time to Continence
Time to continence was based on the time point at which participants reported no urinary incontinence on the International Consultation on Incontinence (ICI) Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). ICIQ-UI SF is one of a series of ICI questionnaires that have been meticulously developed and tested. The ICIQ-UI SF is a brief (4 items), reliable (Cronbach's alpha = 0.95), questionnaire that quantifies both symptom burden and impact of incontinence and has been validated in men and women. It was administered weekly during the 6 months after surgery. Scores range from 0-21; higher scores indicate worse condition.
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telehealth With Pelvic Floor Muscle Training | Time to Continence | NA weeks |
| Telehealth Without Pelvic Floor Muscle Training | Time to Continence | NA weeks |
Activity Restriction
Single quality of life question: How much does leakage of urine restrict your activities? (not at all, some of the time, most of the time, all of the time).
Time frame: 6 months, 9 months, 12 months
Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Telehealth With Pelvic Floor Muscle Training | Activity Restriction | 9 months | All of the time | 5 Participants |
| Telehealth With Pelvic Floor Muscle Training | Activity Restriction | 12 months | Not at all | 74 Participants |
| Telehealth With Pelvic Floor Muscle Training | Activity Restriction | 12 months | Some of the time | 19 Participants |
| Telehealth With Pelvic Floor Muscle Training | Activity Restriction | 12 months | Most of the time | 4 Participants |
| Telehealth With Pelvic Floor Muscle Training | Activity Restriction | 12 months | All of the time | 4 Participants |
| Telehealth With Pelvic Floor Muscle Training | Activity Restriction | 6 months | Not at all | 57 Participants |
| Telehealth With Pelvic Floor Muscle Training | Activity Restriction | 6 months | Some of the time | 34 Participants |
| Telehealth With Pelvic Floor Muscle Training | Activity Restriction | 6 months | Most of the time | 4 Participants |
| Telehealth With Pelvic Floor Muscle Training | Activity Restriction | 6 months | All of the time | 6 Participants |
| Telehealth With Pelvic Floor Muscle Training | Activity Restriction | 9 months | Not at all | 70 Participants |
| Telehealth With Pelvic Floor Muscle Training | Activity Restriction | 9 months | Some of the time | 25 Participants |
| Telehealth With Pelvic Floor Muscle Training | Activity Restriction | 9 months | Most of the time | 1 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Activity Restriction | 9 months | Some of the time | 23 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Activity Restriction | 9 months | All of the time | 4 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Activity Restriction | 6 months | Some of the time | 34 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Activity Restriction | 12 months | Not at all | 65 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Activity Restriction | 9 months | Not at all | 63 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Activity Restriction | 12 months | Some of the time | 17 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Activity Restriction | 6 months | Most of the time | 7 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Activity Restriction | 12 months | Most of the time | 7 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Activity Restriction | 9 months | Most of the time | 4 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Activity Restriction | 12 months | All of the time | 5 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Activity Restriction | 6 months | All of the time | 5 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Activity Restriction | 6 months | Not at all | 48 Participants |
Estimated Percent Improvement (EPI)
Participant self-report of perceived percent improvement from 0% to 100%
Time frame: 6 months, 9 months, 12 months
Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telehealth With Pelvic Floor Muscle Training | Estimated Percent Improvement (EPI) | 6 months | 69.6 percent improvement | Standard Deviation 29.6 |
| Telehealth With Pelvic Floor Muscle Training | Estimated Percent Improvement (EPI) | 9 months | 76.0 percent improvement | Standard Deviation 26.2 |
| Telehealth With Pelvic Floor Muscle Training | Estimated Percent Improvement (EPI) | 12 months | 77.4 percent improvement | Standard Deviation 28.7 |
| Telehealth Without Pelvic Floor Muscle Training | Estimated Percent Improvement (EPI) | 6 months | 65.1 percent improvement | Standard Deviation 34.5 |
| Telehealth Without Pelvic Floor Muscle Training | Estimated Percent Improvement (EPI) | 9 months | 72.6 percent improvement | Standard Deviation 31.8 |
| Telehealth Without Pelvic Floor Muscle Training | Estimated Percent Improvement (EPI) | 12 months | 75.7 percent improvement | Standard Deviation 28.8 |
Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)
This measure, validated as a stand-alone assessment, consists of 4 questions from the full Expanded Prostate Cancer Index (EPIC), a health-related quality of life assessment tool. The EPIC was developed based on advice from an expert panel and prostate cancer survivors, expanding the 20-item University of California - Los Angeles Prostate Cancer Index. Scores range from 0-100; higher scores indicate worse condition.
Time frame: 6 months, 9 months, 12 months
Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telehealth With Pelvic Floor Muscle Training | Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI) | 6 months | 63.9 score on a scale | Standard Deviation 22.1 |
| Telehealth With Pelvic Floor Muscle Training | Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI) | 9 months | 67.7 score on a scale | Standard Deviation 21.2 |
| Telehealth With Pelvic Floor Muscle Training | Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI) | 12 months | 70.4 score on a scale | Standard Deviation 20.4 |
| Telehealth Without Pelvic Floor Muscle Training | Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI) | 6 months | 63.5 score on a scale | Standard Deviation 24.1 |
| Telehealth Without Pelvic Floor Muscle Training | Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI) | 9 months | 65.1 score on a scale | Standard Deviation 26.2 |
| Telehealth Without Pelvic Floor Muscle Training | Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI) | 12 months | 68.0 score on a scale | Standard Deviation 25.3 |
Global Perception of Improvement (GPI)
Participant's global perception of their improvement (Much better, Better, About the same, Worse, Much worse)
Time frame: 6 months, 9 months, 12 months
Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 6 months | Much worse | 3 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 9 months | Better | 45 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 12 months | About the same | 12 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 9 months | About the same | 9 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 6 months | Better | 41 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 9 months | Worse | 3 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 9 months | Much better | 41 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 9 months | Much worse | 3 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 6 months | About the same | 15 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 12 months | Much better | 51 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 12 months | Worse | 2 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 12 months | Better | 31 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 6 months | Worse | 3 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 12 months | Much worse | 5 Participants |
| Telehealth With Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 6 months | Much better | 39 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 12 months | Much worse | 4 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 9 months | Much better | 43 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 12 months | Better | 25 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 12 months | About the same | 19 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 6 months | Much better | 43 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 6 months | Better | 29 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 6 months | About the same | 16 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 6 months | Worse | 2 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 9 months | Better | 29 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 9 months | About the same | 15 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 9 months | Worse | 4 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 9 months | Much worse | 3 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 12 months | Much better | 43 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 12 months | Worse | 3 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Global Perception of Improvement (GPI) | 6 months | Much worse | 4 Participants |
How Disturbing is Urine Leakage
Single quality of life question: How disturbing is the urine leakage problem to you? (not at all, somewhat, or extremely disturbing)
Time frame: 6 months, 9 months, 12 months
Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Telehealth With Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 6 months | Somewhat | 54 Participants |
| Telehealth With Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 9 months | Extremely | 6 Participants |
| Telehealth With Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 6 months | Not at all | 39 Participants |
| Telehealth With Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 12 months | Not at all | 43 Participants |
| Telehealth With Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 6 months | Extremely | 8 Participants |
| Telehealth With Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 12 months | Somewhat | 51 Participants |
| Telehealth With Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 9 months | Somewhat | 53 Participants |
| Telehealth With Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 12 months | Extremely | 7 Participants |
| Telehealth With Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 9 months | Not at all | 42 Participants |
| Telehealth Without Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 12 months | Extremely | 11 Participants |
| Telehealth Without Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 9 months | Not at all | 42 Participants |
| Telehealth Without Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 6 months | Not at all | 41 Participants |
| Telehealth Without Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 6 months | Somewhat | 42 Participants |
| Telehealth Without Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 6 months | Extremely | 11 Participants |
| Telehealth Without Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 9 months | Somewhat | 45 Participants |
| Telehealth Without Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 9 months | Extremely | 7 Participants |
| Telehealth Without Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 12 months | Not at all | 49 Participants |
| Telehealth Without Pelvic Floor Muscle Training | How Disturbing is Urine Leakage | 12 months | Somewhat | 34 Participants |
Incontinence Impact Questionnaire - Short Form (IIQ-SF)
This measure, validated in men with post-prostatectomy incontinence, measures the impact of incontinence on regular activities. It is a condition-specific quality of life measure that has been widely used in incontinence clinical trials. There are seven items. Response options are: not at all, slightly, moderately, greatly. Scores range from 0-100; higher scores indicate greater impact.
Time frame: 6 months, 9 months, 12 months
Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telehealth With Pelvic Floor Muscle Training | Incontinence Impact Questionnaire - Short Form (IIQ-SF) | 6 months | 19.4 score on a scale | Standard Deviation 22.4 |
| Telehealth With Pelvic Floor Muscle Training | Incontinence Impact Questionnaire - Short Form (IIQ-SF) | 9 months | 15.2 score on a scale | Standard Deviation 21.4 |
| Telehealth With Pelvic Floor Muscle Training | Incontinence Impact Questionnaire - Short Form (IIQ-SF) | 12 months | 13.5 score on a scale | Standard Deviation 20.7 |
| Telehealth Without Pelvic Floor Muscle Training | Incontinence Impact Questionnaire - Short Form (IIQ-SF) | 6 months | 22.3 score on a scale | Standard Deviation 24.1 |
| Telehealth Without Pelvic Floor Muscle Training | Incontinence Impact Questionnaire - Short Form (IIQ-SF) | 9 months | 19.3 score on a scale | Standard Deviation 24.9 |
| Telehealth Without Pelvic Floor Muscle Training | Incontinence Impact Questionnaire - Short Form (IIQ-SF) | 12 months | 16.5 score on a scale | Standard Deviation 23.7 |
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form total score. Scores range from 0-21; higher scores indicate worse condition.
Time frame: 6 months, 9 months, 12 months
Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telehealth With Pelvic Floor Muscle Training | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score | 6 months | 7.1 score on a scale | Standard Deviation 4.3 |
| Telehealth With Pelvic Floor Muscle Training | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score | 9 months | 6.2 score on a scale | Standard Deviation 3.9 |
| Telehealth With Pelvic Floor Muscle Training | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score | 12 months | 5.9 score on a scale | Standard Deviation 4.1 |
| Telehealth Without Pelvic Floor Muscle Training | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score | 6 months | 7.0 score on a scale | Standard Deviation 4.4 |
| Telehealth Without Pelvic Floor Muscle Training | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score | 9 months | 6.7 score on a scale | Standard Deviation 5.1 |
| Telehealth Without Pelvic Floor Muscle Training | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score | 12 months | 6.0 score on a scale | Standard Deviation 4.7 |
International Prostate Symptom Scale - Quality of Life Question
Validated single question: If you were to spend the rest of your life with your urinary problem the way it is now, how would you feel about that? Response options: delighted, pleased, mostly satisfied, mixed (about equally satisfied and dissatisfied), mostly dissatisfied, unhappy, terrible.
Time frame: 6 months, 9 months, 12 months
Population: In both arms, the Outcome Measure Data Table reflects the average frequencies across 10 multiple imputations, so the sum of individual frequencies may not exactly equal the total number of participants due to rounding. Two individuals were missing all outcome measures; their data were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 9 months Mostly satisfied | 22 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 9 months Mostly dissatisfied | 12 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 6 months Mostly satisfied | 27 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 9 months Unhappy/Terrible | 11 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 9 months Delighted/Pleased | 36 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 12 months Delighted/Pleased | 41 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 6 months Mixed | 27 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 12 months Mostly satisfied | 28 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 6 months Unhappy/Terrible | 14 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 12 months Mixed | 17 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 6 months Mostly dissatisfied | 13 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 12 months Mostly dissatistied | 9 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 9 months Mixed | 20 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 12 months Unhappy/Terrible | 6 Participants |
| Telehealth With Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 6 months Delighted/Pleased | 21 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 12 months Unhappy/Terrible | 10 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 6 months Delighted/Pleased | 30 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 6 months Mostly dissatisfied | 11 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 6 months Unhappy/Terrible | 14 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 9 months Delighted/Pleased | 32 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 9 months Mostly satisfied | 27 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 6 months Mostly satisfied | 21 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 6 months Mixed | 18 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 9 months Mixed | 9 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 9 months Mostly dissatisfied | 10 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 9 months Unhappy/Terrible | 16 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 12 months Delighted/Pleased | 39 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 12 months Mostly satisfied | 25 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 12 months Mixed | 12 Participants |
| Telehealth Without Pelvic Floor Muscle Training | International Prostate Symptom Scale - Quality of Life Question | 12 months Mostly dissatistied | 8 Participants |
Patient Satisfaction Question (PSQ)
Patient's rating of satisfaction (Completely satisfied, Somewhat satisfied, Not at all satisfied)
Time frame: 6 months, 9 months, 12 months
Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group. The frequencies for both Telehealth With and Without Pelvic Floor Muscle Training were calculated across 10 multiple imputations and rounded to the nearest whole number, so sum of individual categories (102) does not equal overall number of participants (101).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Telehealth With Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 6 months | Somewhat satisfied | 61 Participants |
| Telehealth With Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 9 months | Not at all satisfied | 4 Participants |
| Telehealth With Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 9 months | Completely satisfied | 44 Participants |
| Telehealth With Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 12 months | Completely satisfied | 54 Participants |
| Telehealth With Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 6 months | Not at all satisfied | 5 Participants |
| Telehealth With Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 12 months | Somewhat satisfied | 42 Participants |
| Telehealth With Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 9 months | Somewhat satisfied | 53 Participants |
| Telehealth With Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 12 months | Not at all satisfied | 5 Participants |
| Telehealth With Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 6 months | Completely satisfied | 35 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 12 months | Not at all satisfied | 10 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 6 months | Completely satisfied | 48 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 6 months | Somewhat satisfied | 38 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 6 months | Not at all satisfied | 8 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 9 months | Completely satisfied | 46 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 9 months | Somewhat satisfied | 37 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 9 months | Not at all satisfied | 11 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 12 months | Completely satisfied | 50 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Patient Satisfaction Question (PSQ) | 12 months | Somewhat satisfied | 34 Participants |
Resumption of Normal Activity
Single quality of life question: Have you been able to resume your usual activities since your surgery? (yes, no)
Time frame: 6 months, 9 months, 12 months
Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Telehealth With Pelvic Floor Muscle Training | Resumption of Normal Activity | 6 months | All | 73 Participants |
| Telehealth With Pelvic Floor Muscle Training | Resumption of Normal Activity | 12 months | None | 4 Participants |
| Telehealth With Pelvic Floor Muscle Training | Resumption of Normal Activity | 9 months | Some | 19 Participants |
| Telehealth With Pelvic Floor Muscle Training | Resumption of Normal Activity | 12 months | Some | 16 Participants |
| Telehealth With Pelvic Floor Muscle Training | Resumption of Normal Activity | 9 months | None | 4 Participants |
| Telehealth With Pelvic Floor Muscle Training | Resumption of Normal Activity | 12 months | All | 81 Participants |
| Telehealth With Pelvic Floor Muscle Training | Resumption of Normal Activity | 9 months | All | 78 Participants |
| Telehealth With Pelvic Floor Muscle Training | Resumption of Normal Activity | 6 months | None | 5 Participants |
| Telehealth With Pelvic Floor Muscle Training | Resumption of Normal Activity | 6 months | Some | 23 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Resumption of Normal Activity | 6 months | None | 7 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Resumption of Normal Activity | 6 months | Some | 28 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Resumption of Normal Activity | 6 months | All | 59 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Resumption of Normal Activity | 9 months | None | 5 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Resumption of Normal Activity | 9 months | Some | 19 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Resumption of Normal Activity | 9 months | All | 70 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Resumption of Normal Activity | 12 months | None | 3 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Resumption of Normal Activity | 12 months | Some | 17 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Resumption of Normal Activity | 12 months | All | 74 Participants |
Return to Work
Single quality of life question: Have you been able to return to work since your surgery? (yes, no, retired or disabled)
Time frame: 6 months, 9 months, 12 months
Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Telehealth With Pelvic Floor Muscle Training | Return to Work | 6 months | Retired or disabled | 34 Participants |
| Telehealth With Pelvic Floor Muscle Training | Return to Work | 12 months | No, not yet recovered from surgery | 3 Participants |
| Telehealth With Pelvic Floor Muscle Training | Return to Work | 6 months | No, other reason | 1 Participants |
| Telehealth With Pelvic Floor Muscle Training | Return to Work | 9 months | Yes | 62 Participants |
| Telehealth With Pelvic Floor Muscle Training | Return to Work | 9 months | No, not yet recovered from surgery | 3 Participants |
| Telehealth With Pelvic Floor Muscle Training | Return to Work | 9 months | Retired or disabled | 35 Participants |
| Telehealth With Pelvic Floor Muscle Training | Return to Work | 9 months | No, other reason | 1 Participants |
| Telehealth With Pelvic Floor Muscle Training | Return to Work | 6 months | No, not yet recovered from surgery | 3 Participants |
| Telehealth With Pelvic Floor Muscle Training | Return to Work | 12 months | No, other reason | 1 Participants |
| Telehealth With Pelvic Floor Muscle Training | Return to Work | 12 months | Yes | 66 Participants |
| Telehealth With Pelvic Floor Muscle Training | Return to Work | 12 months | Retired or disabled | 31 Participants |
| Telehealth With Pelvic Floor Muscle Training | Return to Work | 6 months | Yes | 63 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Return to Work | 12 months | Retired or disabled | 36 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Return to Work | 6 months | Yes | 49 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Return to Work | 6 months | No, not yet recovered from surgery | 5 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Return to Work | 6 months | No, other reason | 2 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Return to Work | 6 months | Retired or disabled | 38 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Return to Work | 9 months | Retired or disabled | 34 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Return to Work | 12 months | Yes | 52 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Return to Work | 12 months | No, not yet recovered from surgery | 4 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Return to Work | 9 months | Yes | 55 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Return to Work | 9 months | No, not yet recovered from surgery | 2 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Return to Work | 9 months | No, other reason | 3 Participants |
| Telehealth Without Pelvic Floor Muscle Training | Return to Work | 12 months | No, other reason | 2 Participants |