Trial Outcomes & Findings for Perioperative Post-Prostatectomy Incontinence Home Telehealth Program (NCT NCT01960998)
NCT ID: NCT01960998
Last Updated: 2021-08-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
245 participants
Primary outcome timeframe
6 months
Results posted on
2021-08-09
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
96
|
|
Overall Study
COMPLETED
|
90
|
85
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
2
|
|
Overall Study
lost computer access
|
0
|
1
|
Baseline Characteristics
Perioperative Post-Prostatectomy Incontinence Home Telehealth Program
Baseline characteristics by cohort
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=122 Participants
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.
|
Telehealth Without Pelvic Floor Muscle Training
n=123 Participants
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.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 7.8 • n=99 Participants
|
61.7 years
STANDARD_DEVIATION 7.1 • n=107 Participants
|
61.7 years
STANDARD_DEVIATION 7.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=99 Participants
|
123 Participants
n=107 Participants
|
245 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=99 Participants
|
121 Participants
n=107 Participants
|
243 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
122 participants
n=99 Participants
|
123 participants
n=107 Participants
|
245 participants
n=206 Participants
|
|
Body mass index
|
28.2 kg/m^2
STANDARD_DEVIATION 4.61 • n=99 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 4.54 • n=107 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 4.6 • n=206 Participants
|
|
Education
< High school
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Education
HS or GED
|
39 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Education
College or beyond
|
82 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
167 Participants
n=206 Participants
|
|
Employment
Employed
|
69 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
144 Participants
n=206 Participants
|
|
Employment
Retired, disabled, or unemployed
|
53 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Living situation
Live alone
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Living situation
Live with family
|
104 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
213 Participants
n=206 Participants
|
|
Living situation
Other
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Smoking status
Current smoker
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Smoking status
Former smoker
|
46 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Smoking status
Never smoked
|
62 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Degenerative disc disease
Don't know
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Degenerative disc disease
No
|
103 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
199 Participants
n=206 Participants
|
|
Degenerative disc disease
Yes
|
18 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Asthma, COPD
No
|
108 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
221 Participants
n=206 Participants
|
|
Asthma, COPD
Yes
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Heart failure
No
|
121 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
241 Participants
n=206 Participants
|
|
Heart failure
Yes
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Diabetes
No
|
98 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
207 Participants
n=206 Participants
|
|
Diabetes
Yes
|
24 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Neurological disease
No
|
119 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
239 Participants
n=206 Participants
|
|
Neurological disease
Yes
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Stroke or TIA
No
|
117 Participants
n=99 Participants
|
121 Participants
n=107 Participants
|
238 Participants
n=206 Participants
|
|
Stroke or TIA
Yes
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Depression
No
|
103 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
205 Participants
n=206 Participants
|
|
Depression
Yes
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Anxiety
No
|
111 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
213 Participants
n=206 Participants
|
|
Anxiety
Yes
|
10 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Anxiety
Missing
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Prostate specific antigen (PSA), ng/mL
< 10
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Prostate specific antigen (PSA), ng/mL
> or +10
|
119 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
234 Participants
n=206 Participants
|
|
Gleason score
< 7
|
32 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Gleason score
> or =7
|
90 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
|
Surgical approach
Retropubic
|
102 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
199 Participants
n=206 Participants
|
|
Surgical approach
Perineal
|
8 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Surgical approach
Missing
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Surgical technique
Open
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Surgical technique
Robotic
|
106 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
217 Participants
n=206 Participants
|
|
Surgical technique
Missing
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Neurovascular bundle sparing
Both spared
|
93 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
192 Participants
n=206 Participants
|
|
Neurovascular bundle sparing
One spared
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Neurovascular bundle sparing
None spared
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Neurovascular bundle sparing
Missing
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTime 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.
Outcome measures
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 Participants
Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training 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. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.
|
Telehealth Without Pelvic Floor Muscle Training
n=96 Participants
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.
|
|---|---|---|
|
Time to Continence
|
NA weeks
Median survival time exceeded the observation period of 12 months in the telehealth group
|
NA weeks
Median survival time exceeded the observation period of 12 months in the no telehealth group
|
SECONDARY outcome
Timeframe: 6 months, 9 months, 12 monthsPopulation: 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.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form total score. Scores range from 0-21; higher scores indicate worse condition.
Outcome measures
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 Participants
Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training 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. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.
|
Telehealth Without Pelvic Floor Muscle Training
n=94 Participants
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.
|
|---|---|---|
|
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
|
7.0 score on a scale
Standard Deviation 4.4
|
|
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
|
6.7 score on a scale
Standard Deviation 5.1
|
|
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
|
6.0 score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 6 months, 9 months, 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 Participants
Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training 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. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.
|
Telehealth Without Pelvic Floor Muscle Training
n=94 Participants
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.
|
|---|---|---|
|
Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)
6 months
|
63.9 score on a scale
Standard Deviation 22.1
|
63.5 score on a scale
Standard Deviation 24.1
|
|
Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)
9 months
|
67.7 score on a scale
Standard Deviation 21.2
|
65.1 score on a scale
Standard Deviation 26.2
|
|
Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)
12 months
|
70.4 score on a scale
Standard Deviation 20.4
|
68.0 score on a scale
Standard Deviation 25.3
|
SECONDARY outcome
Timeframe: 6 months, 9 months, 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 Participants
Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training 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. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.
|
Telehealth Without Pelvic Floor Muscle Training
n=94 Participants
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.
|
|---|---|---|
|
Incontinence Impact Questionnaire - Short Form (IIQ-SF)
6 months
|
19.4 score on a scale
Standard Deviation 22.4
|
22.3 score on a scale
Standard Deviation 24.1
|
|
Incontinence Impact Questionnaire - Short Form (IIQ-SF)
9 months
|
15.2 score on a scale
Standard Deviation 21.4
|
19.3 score on a scale
Standard Deviation 24.9
|
|
Incontinence Impact Questionnaire - Short Form (IIQ-SF)
12 months
|
13.5 score on a scale
Standard Deviation 20.7
|
16.5 score on a scale
Standard Deviation 23.7
|
SECONDARY outcome
Timeframe: 6 months, 9 months, 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 Participants
Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training 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. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.
|
Telehealth Without Pelvic Floor Muscle Training
n=94 Participants
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.
|
|---|---|---|
|
International Prostate Symptom Scale - Quality of Life Question
9 months Delighted/Pleased
|
36 Participants
|
32 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
9 months Mostly satisfied
|
22 Participants
|
27 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
9 months Mixed
|
20 Participants
|
9 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
9 months Mostly dissatisfied
|
12 Participants
|
10 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
9 months Unhappy/Terrible
|
11 Participants
|
16 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
12 months Delighted/Pleased
|
41 Participants
|
39 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
12 months Mostly satisfied
|
28 Participants
|
25 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
12 months Mixed
|
17 Participants
|
12 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
12 months Mostly dissatistied
|
9 Participants
|
8 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
12 months Unhappy/Terrible
|
6 Participants
|
10 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
6 months Delighted/Pleased
|
21 Participants
|
30 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
6 months Mostly satisfied
|
27 Participants
|
21 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
6 months Mixed
|
27 Participants
|
18 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
6 months Mostly dissatisfied
|
13 Participants
|
11 Participants
|
|
International Prostate Symptom Scale - Quality of Life Question
6 months Unhappy/Terrible
|
14 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 months, 9 months, 12 monthsPopulation: 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).
Patient's rating of satisfaction (Completely satisfied, Somewhat satisfied, Not at all satisfied)
Outcome measures
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 Participants
Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training 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. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.
|
Telehealth Without Pelvic Floor Muscle Training
n=94 Participants
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.
|
|---|---|---|
|
Patient Satisfaction Question (PSQ)
6 months · Completely satisfied
|
35 Participants
|
48 Participants
|
|
Patient Satisfaction Question (PSQ)
6 months · Somewhat satisfied
|
61 Participants
|
38 Participants
|
|
Patient Satisfaction Question (PSQ)
6 months · Not at all satisfied
|
5 Participants
|
8 Participants
|
|
Patient Satisfaction Question (PSQ)
9 months · Completely satisfied
|
44 Participants
|
46 Participants
|
|
Patient Satisfaction Question (PSQ)
9 months · Somewhat satisfied
|
53 Participants
|
37 Participants
|
|
Patient Satisfaction Question (PSQ)
9 months · Not at all satisfied
|
4 Participants
|
11 Participants
|
|
Patient Satisfaction Question (PSQ)
12 months · Completely satisfied
|
54 Participants
|
50 Participants
|
|
Patient Satisfaction Question (PSQ)
12 months · Somewhat satisfied
|
42 Participants
|
34 Participants
|
|
Patient Satisfaction Question (PSQ)
12 months · Not at all satisfied
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6 months, 9 months, 12 monthsPopulation: 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.
Participant self-report of perceived percent improvement from 0% to 100%
Outcome measures
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 Participants
Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training 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. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.
|
Telehealth Without Pelvic Floor Muscle Training
n=94 Participants
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.
|
|---|---|---|
|
Estimated Percent Improvement (EPI)
6 months
|
69.6 percent improvement
Standard Deviation 29.6
|
65.1 percent improvement
Standard Deviation 34.5
|
|
Estimated Percent Improvement (EPI)
9 months
|
76.0 percent improvement
Standard Deviation 26.2
|
72.6 percent improvement
Standard Deviation 31.8
|
|
Estimated Percent Improvement (EPI)
12 months
|
77.4 percent improvement
Standard Deviation 28.7
|
75.7 percent improvement
Standard Deviation 28.8
|
SECONDARY outcome
Timeframe: 6 months, 9 months, 12 monthsPopulation: 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.
Participant's global perception of their improvement (Much better, Better, About the same, Worse, Much worse)
Outcome measures
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 Participants
Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training 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. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.
|
Telehealth Without Pelvic Floor Muscle Training
n=94 Participants
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.
|
|---|---|---|
|
Global Perception of Improvement (GPI)
6 months · Much better
|
39 Participants
|
43 Participants
|
|
Global Perception of Improvement (GPI)
6 months · Better
|
41 Participants
|
29 Participants
|
|
Global Perception of Improvement (GPI)
6 months · About the same
|
15 Participants
|
16 Participants
|
|
Global Perception of Improvement (GPI)
6 months · Worse
|
3 Participants
|
2 Participants
|
|
Global Perception of Improvement (GPI)
6 months · Much worse
|
3 Participants
|
4 Participants
|
|
Global Perception of Improvement (GPI)
9 months · Much better
|
41 Participants
|
43 Participants
|
|
Global Perception of Improvement (GPI)
9 months · Better
|
45 Participants
|
29 Participants
|
|
Global Perception of Improvement (GPI)
9 months · About the same
|
9 Participants
|
15 Participants
|
|
Global Perception of Improvement (GPI)
9 months · Worse
|
3 Participants
|
4 Participants
|
|
Global Perception of Improvement (GPI)
9 months · Much worse
|
3 Participants
|
3 Participants
|
|
Global Perception of Improvement (GPI)
12 months · Much better
|
51 Participants
|
43 Participants
|
|
Global Perception of Improvement (GPI)
12 months · Better
|
31 Participants
|
25 Participants
|
|
Global Perception of Improvement (GPI)
12 months · About the same
|
12 Participants
|
19 Participants
|
|
Global Perception of Improvement (GPI)
12 months · Worse
|
2 Participants
|
3 Participants
|
|
Global Perception of Improvement (GPI)
12 months · Much worse
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 months, 9 months, 12 monthsPopulation: 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.
Single quality of life question: "How disturbing is the urine leakage problem to you?" (not at all, somewhat, or extremely disturbing)
Outcome measures
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 Participants
Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training 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. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.
|
Telehealth Without Pelvic Floor Muscle Training
n=94 Participants
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.
|
|---|---|---|
|
How Disturbing is Urine Leakage
6 months · Not at all
|
39 Participants
|
41 Participants
|
|
How Disturbing is Urine Leakage
6 months · Somewhat
|
54 Participants
|
42 Participants
|
|
How Disturbing is Urine Leakage
6 months · Extremely
|
8 Participants
|
11 Participants
|
|
How Disturbing is Urine Leakage
9 months · Not at all
|
42 Participants
|
42 Participants
|
|
How Disturbing is Urine Leakage
9 months · Somewhat
|
53 Participants
|
45 Participants
|
|
How Disturbing is Urine Leakage
9 months · Extremely
|
6 Participants
|
7 Participants
|
|
How Disturbing is Urine Leakage
12 months · Not at all
|
43 Participants
|
49 Participants
|
|
How Disturbing is Urine Leakage
12 months · Somewhat
|
51 Participants
|
34 Participants
|
|
How Disturbing is Urine Leakage
12 months · Extremely
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 months, 9 months, 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 Participants
Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training 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. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.
|
Telehealth Without Pelvic Floor Muscle Training
n=94 Participants
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.
|
|---|---|---|
|
Activity Restriction
6 months · Not at all
|
57 Participants
|
48 Participants
|
|
Activity Restriction
6 months · Some of the time
|
34 Participants
|
34 Participants
|
|
Activity Restriction
6 months · Most of the time
|
4 Participants
|
7 Participants
|
|
Activity Restriction
6 months · All of the time
|
6 Participants
|
5 Participants
|
|
Activity Restriction
9 months · Not at all
|
70 Participants
|
63 Participants
|
|
Activity Restriction
9 months · Some of the time
|
25 Participants
|
23 Participants
|
|
Activity Restriction
9 months · Most of the time
|
1 Participants
|
4 Participants
|
|
Activity Restriction
9 months · All of the time
|
5 Participants
|
4 Participants
|
|
Activity Restriction
12 months · Not at all
|
74 Participants
|
65 Participants
|
|
Activity Restriction
12 months · Some of the time
|
19 Participants
|
17 Participants
|
|
Activity Restriction
12 months · Most of the time
|
4 Participants
|
7 Participants
|
|
Activity Restriction
12 months · All of the time
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 months, 9 months, 12 monthsPopulation: 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.
Single quality of life question: "Have you been able to return to work since your surgery?" (yes, no, retired or disabled)
Outcome measures
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 Participants
Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training 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. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.
|
Telehealth Without Pelvic Floor Muscle Training
n=94 Participants
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.
|
|---|---|---|
|
Return to Work
6 months · Yes
|
63 Participants
|
49 Participants
|
|
Return to Work
6 months · No, not yet recovered from surgery
|
3 Participants
|
5 Participants
|
|
Return to Work
6 months · No, other reason
|
1 Participants
|
2 Participants
|
|
Return to Work
6 months · Retired or disabled
|
34 Participants
|
38 Participants
|
|
Return to Work
9 months · Yes
|
62 Participants
|
55 Participants
|
|
Return to Work
9 months · No, not yet recovered from surgery
|
3 Participants
|
2 Participants
|
|
Return to Work
9 months · No, other reason
|
1 Participants
|
3 Participants
|
|
Return to Work
9 months · Retired or disabled
|
35 Participants
|
34 Participants
|
|
Return to Work
12 months · Yes
|
66 Participants
|
52 Participants
|
|
Return to Work
12 months · No, not yet recovered from surgery
|
3 Participants
|
4 Participants
|
|
Return to Work
12 months · No, other reason
|
1 Participants
|
2 Participants
|
|
Return to Work
12 months · Retired or disabled
|
31 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 6 months, 9 months, 12 monthsPopulation: 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.
Single quality of life question: "Have you been able to resume your usual activities since your surgery?" (yes, no)
Outcome measures
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 Participants
Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training 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. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.
|
Telehealth Without Pelvic Floor Muscle Training
n=94 Participants
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.
|
|---|---|---|
|
Resumption of Normal Activity
6 months · None
|
5 Participants
|
7 Participants
|
|
Resumption of Normal Activity
6 months · Some
|
23 Participants
|
28 Participants
|
|
Resumption of Normal Activity
6 months · All
|
73 Participants
|
59 Participants
|
|
Resumption of Normal Activity
9 months · None
|
4 Participants
|
5 Participants
|
|
Resumption of Normal Activity
9 months · Some
|
19 Participants
|
19 Participants
|
|
Resumption of Normal Activity
9 months · All
|
78 Participants
|
70 Participants
|
|
Resumption of Normal Activity
12 months · None
|
4 Participants
|
3 Participants
|
|
Resumption of Normal Activity
12 months · Some
|
16 Participants
|
17 Participants
|
|
Resumption of Normal Activity
12 months · All
|
81 Participants
|
74 Participants
|
Adverse Events
Telehealth With Pelvic Floor Muscle Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Telehealth Without Pelvic Floor Muscle Training
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 participants at risk
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.
|
Telehealth Without Pelvic Floor Muscle Training
n=96 participants at risk
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.
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/101 • 12 months
|
1.0%
1/96 • 12 months
|
Other adverse events
| Measure |
Telehealth With Pelvic Floor Muscle Training
n=101 participants at risk
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.
|
Telehealth Without Pelvic Floor Muscle Training
n=96 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Complications of surgery
|
0.00%
0/101 • 12 months
|
1.0%
1/96 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place