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| Name | Class |
|---|---|
| Emory University | OTHER |
| University of Pennsylvania | OTHER |
| University of Alabama at Birmingham | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth with Pelvic Floor Muscle Training | Experimental | 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 month 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. |
|
| Telehealth without Pelvic Floor Muscle Training | Active Comparator | 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 3 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic Floor Muscle Training | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months, 9 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Men planning surgery for prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn L Burgio, PhD MA BA | Birmingham VA Medical Center, Birmingham, AL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham VA Medical Center | Birmingham | Alabama | 35233 | United States | ||
| Atlanta VA Medical and Rehab Center, Decatur, GA |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 month 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 2-4 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. |
| FG001 | 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 3 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | 95% Confidence Interval | weeks | 6 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | Participant's wife informed the study coordinator that the participant had passed away, after the study coordinator attempted to contact the participant. The event was determined to be anticipated in an older adult and unrelated to the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complications of surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn L. Burgio, PhD | Birmingham VA Medcial Center | 205-999-9537 | kburgio@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2016 | Jan 22, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D006296 | Health Services |
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|
| Perioperative Care and Wetness Management | Behavioral | 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. |
|
| 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. |
| 6 months, 9 months, 12 months |
| 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. | 6 months, 9 months, 12 months |
| 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. | 6 months, 9 months, 12 months |
| Patient Satisfaction Question (PSQ) | Patient's rating of satisfaction (Completely satisfied, Somewhat satisfied, Not at all satisfied) | 6 months, 9 months, 12 months |
| Estimated Percent Improvement (EPI) | Participant self-report of perceived percent improvement from 0% to 100% | 6 months, 9 months, 12 months |
| Global Perception of Improvement (GPI) | Participant's global perception of their improvement (Much better, Better, About the same, Worse, Much worse) | 6 months, 9 months, 12 months |
| 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) | 6 months, 9 months, 12 months |
| 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). | 6 months, 9 months, 12 months |
| Return to Work | Single quality of life question: "Have you been able to return to work since your surgery?" (yes, no, retired or disabled) | 6 months, 9 months, 12 months |
| Resumption of Normal Activity | Single quality of life question: "Have you been able to resume your usual activities since your surgery?" (yes, no) | 6 months, 9 months, 12 months |
| Decatur |
| Georgia |
| 30033 |
| United States |
| Philadelphia VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104 | United States |
| Withdrawal by Subject |
|
| lost computer access |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Body mass index is a weight-to-height ratio used as an indicator of obesity and underweight. It is calculated by dividing an individual's weight in kilograms by the square of their height in meters. | Mean | Standard Deviation | kg/m^2 |
|
| Education | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Living situation | Count of Participants | Participants |
|
| Smoking status | Count of Participants | Participants |
|
| Degenerative disc disease | Count of Participants | Participants |
|
| Asthma, COPD | Count of Participants | Participants |
|
| Heart failure | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Neurological disease | Count of Participants | Participants |
|
| Stroke or TIA | Count of Participants | Participants |
|
| Depression | Count of Participants | Participants |
|
| Anxiety | Count of Participants | Participants |
|
| Prostate specific antigen (PSA), ng/mL | Count of Participants | Participants |
|
| Gleason score | The Gleason score is used to describe prostate cancer cells based on pathologist examination of a biopsy sample. The cells are graded on a scale of 1 to 5, with Grade 1 cells resembling normal prostate tissue. Gleason scores usually range from 6 to 10. A Gleason score of 6 is low grade, 7 is intermediate grade, and 8 to 10 is high grade cancer. | Count of Participants | Participants |
|
| Surgical approach | Count of Participants | Participants |
|
| Surgical technique | Count of Participants | Participants |
|
| Neurovascular bundle sparing | The neurovascular bundles lie postero-laterally to the prostate and are typically spared during prostatectomy to preserve sexual function. A "nerve-sparing" procedure involves dissecting the nerve bundle off the side of the prostate. | Count of Participants | Participants |
|
| OG001 | Telehealth Without Pelvic Floor Muscle Training | Participants in this group received a telehealth program that included general perioperative care; wetness, odor and skin care management; and outcome measures. The program was begun 1-4 weeks before surgery and continued 2 months after surgery. Content was 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. |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months, 9 months, 12 months |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months, 9 months, 12 months |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months, 9 months, 12 months |
|
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 6 months, 9 months, 12 months |
|
|
|
|
| Secondary | Patient Satisfaction Question (PSQ) | Patient's rating of satisfaction (Completely satisfied, Somewhat satisfied, Not at all satisfied) | 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). | Posted | Count of Participants | Participants | 6 months, 9 months, 12 months |
|
|
|
|
| Secondary | Estimated Percent Improvement (EPI) | Participant self-report of perceived percent improvement from 0% to 100% | 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. | Posted | Mean | Standard Deviation | percent improvement | 6 months, 9 months, 12 months |
|
|
|
|
| Secondary | Global Perception of Improvement (GPI) | Participant's global perception of their improvement (Much better, Better, About the same, Worse, Much worse) | 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. | Posted | Count of Participants | Participants | 6 months, 9 months, 12 months |
|
|
|
|
| Secondary | 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) | 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. | Posted | Count of Participants | Participants | 6 months, 9 months, 12 months |
|
|
|
|
| Secondary | 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). | 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. | Posted | Count of Participants | Participants | 6 months, 9 months, 12 months |
|
|
|
|
| Secondary | Return to Work | Single quality of life question: "Have you been able to return to work since your surgery?" (yes, no, retired or disabled) | 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. | Posted | Count of Participants | Participants | 6 months, 9 months, 12 months |
|
|
|
|
| Secondary | Resumption of Normal Activity | Single quality of life question: "Have you been able to resume your usual activities since your surgery?" (yes, no) | 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. | Posted | Count of Participants | Participants | 6 months, 9 months, 12 months |
|
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | 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. | 1 | 96 | 1 | 96 | 1 | 96 |
|
Not provided
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
| D005159 |
| Health Care Facilities Workforce and Services |
| 12 months |
|
| 12 months |
|
| 12 months |
|
| 6 months Mixed |
|
| 6 months Mostly dissatisfied |
|
| 6 months Unhappy/Terrible |
|
| 9 months Delighted/Pleased |
|
| 9 months Mostly satisfied |
|
| 9 months Mixed |
|
| 9 months Mostly dissatisfied |
|
| 9 months Unhappy/Terrible |
|
| 12 months Delighted/Pleased |
|
| 12 months Mostly satisfied |
|
| 12 months Mixed |
|
| 12 months Mostly dissatistied |
|
| 12 months Unhappy/Terrible |
|
| Not at all satisfied |
|
| 9 months |
|
| 12 months |
|
| 12 months |
|
| About the same |
|
| Worse |
|
| Much worse |
|
| 9 months |
|
| 12 months |
|
| Extremely |
|
| 9 months |
|
| 12 months |
|
| Most of the time |
|
| All of the time |
|
| 9 months |
|
| 12 months |
|
| No, other reason |
|
| Retired or disabled |
|
| 9 months |
|
| 12 months |
|
| All |
|
| 9 months |
|
| 12 months |
|