ProsTel: Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01960998
• Collaborator: Emory University (Other), University of Pennsylvania (Other), University of Alabama at Birmingham (Other)
• Enrollment: 245
• Locations: 3
• Arms: 2
• Actual Duration (Months): 61.6
• Patients Per Site: 81.7
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence; Prostate Cancer	Behavioral: Pelvic Floor Muscle Training; Behavioral: Perioperative Care and Wetness Management	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 245 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• Official Title: Perioperative Post-Prostatectomy Incontinence Home Telehealth Program
• Actual Study Start Date: Aug 11, 2014
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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; Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. Patient Satisfaction Question (PSQ) [6 months, 9 months, 12 months]

   Patient's rating of satisfaction (Completely satisfied, Somewhat satisfied, Not at all satisfied)

6. Estimated Percent Improvement (EPI) [6 months, 9 months, 12 months]

   Participant self-report of perceived percent improvement from 0% to 100%

7. 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)

8. 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)

9. 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).

10. 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)

11. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham VA Medical Center	Birmingham	Alabama	United States	35233
2	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia	United States	30033
3	Philadelphia VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• VA Office of Research and Development
• Emory University
• University of Pennsylvania
• University of Alabama at Birmingham

Investigators

• Principal Investigator: Kathryn L Burgio, PhD MA BA, Birmingham VA Medical Center, Birmingham, AL

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 25, 2016

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01960998
• Other Study ID Numbers: D1059-R
• First Posted: Oct 11, 2013
• Last Update Posted: Aug 9, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: radical prostatectomy; urinary incontinence; prostate cancer; telehealth; pelvic floor muscle training
• Additional relevant MeSH terms: Prostatic Neoplasms; Urinary Incontinence; Enuresis

Study Results

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.

Arm/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	101	96
COMPLETED	90	85
NOT COMPLETED	11	11

Baseline Characteristics

Arm/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	122	123	245
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.9 (7.8)	61.7 (7.1)	61.7 (7.4)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	122 100%	123 100%	245 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	2 1.6%	2 0.8%
Not Hispanic or Latino	122 100%	121 98.4%	243 99.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 1.6%	1 0.8%	3 1.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	38 31.1%	27 22%	65 26.5%
White	82 67.2%	95 77.2%	177 72.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	122 100%	123 100%	245 100%
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.2 (4.61)	29.6 (4.54)	28.9 (4.6)
Education (Count of Participants)
< High school	1 0.8%	2 1.6%	3 1.2%
HS or GED	39 32%	36 29.3%	75 30.6%
College or beyond	82 67.2%	85 69.1%	167 68.2%
Employment (Count of Participants)
Employed	69 56.6%	75 61%	144 58.8%
Retired, disabled, or unemployed	53 43.4%	48 39%	101 41.2%
Living situation (Count of Participants)
Live alone	14 11.5%	10 8.1%	24 9.8%
Live with family	104 85.2%	109 88.6%	213 86.9%
Other	4 3.3%	4 3.3%	8 3.3%
Smoking status (Count of Participants)
Current smoker	14 11.5%	9 7.3%	23 9.4%
Former smoker	46 37.7%	42 34.1%	88 35.9%
Never smoked	62 50.8%	72 58.5%	134 54.7%
Degenerative disc disease (Count of Participants)
Don't know	1 0.8%	0 0%	1 0.4%
No	103 84.4%	96 78%	199 81.2%
Yes	18 14.8%	27 22%	45 18.4%
Asthma, COPD (Count of Participants)
No	108 88.5%	113 91.9%	221 90.2%
Yes	14 11.5%	10 8.1%	24 9.8%
Heart failure (Count of Participants)
No	121 99.2%	120 97.6%	241 98.4%
Yes	1 0.8%	3 2.4%	4 1.6%
Diabetes (Count of Participants)
No	98 80.3%	109 88.6%	207 84.5%
Yes	24 19.7%	14 11.4%	38 15.5%
Neurological disease (Count of Participants)
No	119 97.5%	120 97.6%	239 97.6%
Yes	3 2.5%	3 2.4%	6 2.4%
Stroke or TIA (Count of Participants)
No	117 95.9%	121 98.4%	238 97.1%
Yes	5 4.1%	2 1.6%	7 2.9%
Depression (Count of Participants)
No	103 84.4%	102 82.9%	205 83.7%
Yes	19 15.6%	21 17.1%	40 16.3%
Anxiety (Count of Participants)
No	111 91%	102 82.9%	213 86.9%
Yes	10 8.2%	21 17.1%	31 12.7%
Missing	1 0.8%	0 0%	1 0.4%
Prostate specific antigen (PSA), ng/mL (Count of Participants)
< 10	3 2.5%	8 6.5%	11 4.5%
> or +10	119 97.5%	115 93.5%	234 95.5%
Gleason score (Count of Participants)
< 7	32 26.2%	36 29.3%	68 27.8%
> or =7	90 73.8%	87 70.7%	177 72.2%
Surgical approach (Count of Participants)
Retropubic	102 83.6%	97 78.9%	199 81.2%
Perineal	8 6.6%	16 13%	24 9.8%
Missing	12 9.8%	10 8.1%	22 9%
Surgical technique (Count of Participants)
Open	5 4.1%	4 3.3%	9 3.7%
Robotic	106 86.9%	111 90.2%	217 88.6%
Missing	11 9%	8 6.5%	19 7.8%
Neurovascular bundle sparing (Count of Participants)
Both spared	93 76.2%	99 80.5%	192 78.4%
One spared	8 6.6%	4 3.3%	12 4.9%
None spared	7 5.7%	4 3.3%	11 4.5%
Missing	14 11.5%	16 13%	30 12.2%

Outcome Measures

1. Primary Outcome

Title	Time to Continence
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.	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.
Measure Participants	101	96
Median (95% Confidence Interval) [weeks]	NA	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telehealth With Pelvic Floor Muscle Training, Telehealth Without Pelvic Floor Muscle Training
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.22
	Comments	P value not adjusted for multiple comparisons
	Method	Log Rank
	Comments
Other Statistical Analysis		Data were not collected beyond the 12-month follow up, at which point fewer than 50% of participants in both groups had achieved continence. Thus, their time to continence could not be determined and the medians could not be calculated.

2. Secondary Outcome

Title	International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.	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.
Measure Participants	101	94
6 months	7.1 (4.3)	7.0 (4.4)
9 months	6.2 (3.9)	6.7 (5.1)
12 months	5.9 (4.1)	6.0 (4.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telehealth With Pelvic Floor Muscle Training, Telehealth Without Pelvic Floor Muscle Training
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.70
	Comments	P values were not corrected for multiple testing
	Method	ANCOVA
	Comments	Baseline score was included as a covariate in analysis.
Other Statistical Analysis		Mean values for the telehealth and no telehealth groups on the ICIQ-SF are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean ICIQ-SF score in the no telehealth group at 6 months was 7.0 (standard deviation 4.4) and in the telehealth group was 7.1 (SD 4.3). Analysis of covariance (ANCOVA) was performed with each of the 10 imputations, adjusting for baseline ICIQ-SF score, and p values were combined using the Rubin-Licht method.

3. Secondary Outcome

Title	Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.	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.
Measure Participants	101	94
6 months	63.9 (22.1)	63.5 (24.1)
9 months	67.7 (21.2)	65.1 (26.2)
12 months	70.4 (20.4)	68.0 (25.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telehealth With Pelvic Floor Muscle Training, Telehealth Without Pelvic Floor Muscle Training
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.70
	Comments	P values were not adjusted for multiple comparisons.
	Method	ANCOVA
	Comments
Other Statistical Analysis		Mean values for the telehealth and no telehealth groups on the EPIC-UI are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean EPIC-UI score in the no telehealth group at 6 months was 63.5 (standard deviation 24.1) and in the telehealth group was 63.9 (SD 22.1). Analysis of covariance (ANCOVA) was performed with each of the 10 imputations, adjusting for baseline EPIC-UI score, and p values were combined using the Rubin-Licht method.

4. Secondary Outcome

Title	Incontinence Impact Questionnaire - Short Form (IIQ-SF)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.	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.
Measure Participants	101	94
6 months	19.4 (22.4)	22.3 (24.1)
9 months	15.2 (21.4)	19.3 (24.9)
12 months	13.5 (20.7)	16.5 (23.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telehealth With Pelvic Floor Muscle Training, Telehealth Without Pelvic Floor Muscle Training
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.46
	Comments	P values not adjusted for multiple comparisons.
	Method	t-test, 2 sided
	Comments
Other Statistical Analysis		Mean values for the telehealth and no telehealth groups on the IIQ are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean IIQ score in the no telehealth group at 6 months was 22.3 (standard deviation 24.1) and in the telehealth group was 19.4 (SD 22.4). Two-sample t-tests were performed with each of the 10 imputations, and p values were combined using the Rubin-Licht method.

5. Secondary Outcome

Title	International Prostate Symptom Scale - Quality of Life Question
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.	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.
Measure Participants	101	94
6 months Delighted/Pleased	21 17.2%	30 24.4%
6 months Mostly satisfied	27 22.1%	21 17.1%
6 months Mixed	27 22.1%	18 14.6%
6 months Mostly dissatisfied	13 10.7%	11 8.9%
6 months Unhappy/Terrible	14 11.5%	14 11.4%
9 months Delighted/Pleased	36 29.5%	32 26%
9 months Mostly satisfied	22 18%	27 22%
9 months Mixed	20 16.4%	9 7.3%
9 months Mostly dissatisfied	12 9.8%	10 8.1%
9 months Unhappy/Terrible	11 9%	16 13%
12 months Delighted/Pleased	41 33.6%	39 31.7%
12 months Mostly satisfied	28 23%	25 20.3%
12 months Mixed	17 13.9%	12 9.8%
12 months Mostly dissatistied	9 7.4%	8 6.5%
12 months Unhappy/Terrible	6 4.9%	10 8.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telehealth With Pelvic Floor Muscle Training, Telehealth Without Pelvic Floor Muscle Training
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.63
	Comments	P values were not corrected for multiple comparisons
	Method	Chi-squared, Corrected
	Comments
Other Statistical Analysis		Frequencies for the telehealth and no telehealth groups on the Quality of Life question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 31.4% (Delighted/Pleased), 22.8% (Mostly Satisfied), 19.4% (Mixed), 12.0% (Mostly Dissatisfied), and 14.4% (Unhappy/Terrible) and in the telehealth group were 20.8%, 26.3%, 26.3%, 12.6%, and 14.0%, respectively. Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 5 levels of the IPSS Quality of Life question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.

6. Secondary Outcome

Title	Patient Satisfaction Question (PSQ)
Description	Patient's rating of satisfaction (Completely satisfied, Somewhat satisfied, Not at all satisfied)
Time Frame	6 months, 9 months, 12 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.	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.
Measure Participants	101	94
Completely satisfied	35 28.7%	48 39%
Somewhat satisfied	61 50%	38 30.9%
Not at all satisfied	5 4.1%	8 6.5%
Completely satisfied	44 36.1%	46 37.4%
Somewhat satisfied	53 43.4%	37 30.1%
Not at all satisfied	4 3.3%	11 8.9%
Completely satisfied	54 44.3%	50 40.7%
Somewhat satisfied	42 34.4%	34 27.6%
Not at all satisfied	5 4.1%	10 8.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telehealth With Pelvic Floor Muscle Training, Telehealth Without Pelvic Floor Muscle Training
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments	P values were not corrected for multiple comparisons
	Method	Chi-squared, Corrected
	Comments
Other Statistical Analysis		Frequencies for the telehealth and no telehealth groups on the Patient Satisfaction question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 51.0% (Completely Satisfied), 40.2% (Somewhat Satisfied), and 8.7% (Not at All Satisfied) and in the telehealth group were 34.8%, 59.9%, and 5.3%, respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the Patient Satisfaction question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.

7. Secondary Outcome

Title	Estimated Percent Improvement (EPI)
Description	Participant self-report of perceived percent improvement from 0% to 100%
Time Frame	6 months, 9 months, 12 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.	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.
Measure Participants	101	94
6 months	69.6 (29.6)	65.1 (34.5)
9 months	76.0 (26.2)	72.6 (31.8)
12 months	77.4 (28.7)	75.7 (28.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telehealth With Pelvic Floor Muscle Training, Telehealth Without Pelvic Floor Muscle Training
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.67
	Comments	P values not adjusted for multiple comparisons
	Method	t-test, 2 sided
	Comments
Other Statistical Analysis		Mean values for the telehealth and no telehealth groups on the Estimated Percent Improvement (EPI) are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean EPI score in the no telehealth group at 6 months was 65.1 (standard deviation 34.5) and in the telehealth group was 69.6 (SD 29.6). Two-sample t-tests were performed with each of the 10 imputations, and p values were combined using the Rubin-Licht method.

8. Secondary Outcome

Title	Global Perception of Improvement (GPI)
Description	Participant's global perception of their improvement (Much better, Better, About the same, Worse, Much worse)
Time Frame	6 months, 9 months, 12 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.	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.
Measure Participants	101	94
Much better	39 32%	43 35%
Better	41 33.6%	29 23.6%
About the same	15 12.3%	16 13%
Worse	3 2.5%	2 1.6%
Much worse	3 2.5%	4 3.3%
Much better	41 33.6%	43 35%
Better	45 36.9%	29 23.6%
About the same	9 7.4%	15 12.2%
Worse	3 2.5%	4 3.3%
Much worse	3 2.5%	3 2.4%
Much better	51 41.8%	43 35%
Better	31 25.4%	25 20.3%
About the same	12 9.8%	19 15.4%
Worse	2 1.6%	3 2.4%
Much worse	5 4.1%	4 3.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telehealth With Pelvic Floor Muscle Training, Telehealth Without Pelvic Floor Muscle Training
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.65
	Comments
	Method	Chi-squared, Corrected
	Comments
Other Statistical Analysis		Frequencies for the telehealth and no telehealth groups on the Global Perception of Improvement (GPI) question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 46.3% (Much Better), 30.7% (Better), 16.7% (About the Same), 2.3% (Worse), and 3.9% (Much Worse) and in the telehealth group were 38.3%, 41.1%, 15.3%, 2.9%, and 2.5%, respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 5 levels of the Global Perception of Improvement question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.

9. Secondary Outcome

Title	How Disturbing is Urine Leakage
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.	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.
Measure Participants	101	94
Not at all	39 32%	41 33.3%
Somewhat	54 44.3%	42 34.1%
Extremely	8 6.6%	11 8.9%
Not at all	42 34.4%	42 34.1%
Somewhat	53 43.4%	45 36.6%
Extremely	6 4.9%	7 5.7%
Not at all	43 35.2%	49 39.8%
Somewhat	51 41.8%	34 27.6%
Extremely	7 5.7%	11 8.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telehealth With Pelvic Floor Muscle Training, Telehealth Without Pelvic Floor Muscle Training
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.37
	Comments	P values were not corrected for multiple comparisons
	Method	Chi-squared, Corrected
	Comments
Other Statistical Analysis		Frequencies for the telehealth and no telehealth groups on the "How Disturbing is the Urine Leakage?" question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 43.5% (Not at All), 44.4% (Somewhat), and 12.1% (Extremely) and in the telehealth group were 38.9%, 53.2%, and 7.9% respectively. Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the "How Disturbing is the Urine Leakage?" question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.

10. Secondary Outcome

Title	Activity Restriction
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.	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.
Measure Participants	101	94
Not at all	57 46.7%	48 39%
Some of the time	34 27.9%	34 27.6%
Most of the time	4 3.3%	7 5.7%
All of the time	6 4.9%	5 4.1%
Not at all	70 57.4%	63 51.2%
Some of the time	25 20.5%	23 18.7%
Most of the time	1 0.8%	4 3.3%
All of the time	5 4.1%	4 3.3%
Not at all	74 60.7%	65 52.8%
Some of the time	19 15.6%	17 13.8%
Most of the time	4 3.3%	7 5.7%
All of the time	4 3.3%	5 4.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telehealth With Pelvic Floor Muscle Training, Telehealth Without Pelvic Floor Muscle Training
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.63
	Comments	P values were not adjusted for multiple comparisons
	Method	Chi-squared, Corrected
	Comments
Other Statistical Analysis		Frequencies for the telehealth and no telehealth groups on the Activity Restriction question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 51.0% (Not at all), 36.5% (Some of the time), 7.2% (Most of the time), and 5.3% (All of the time) and in the telehealth group were 56.5%, 33.5%, 4.2%, and 5.8% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 4 levels of the Activity Restriction question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.

11. Secondary Outcome

Title	Return to Work
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.	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.
Measure Participants	101	94
Yes	63 51.6%	49 39.8%
No, not yet recovered from surgery	3 2.5%	5 4.1%
No, other reason	1 0.8%	2 1.6%
Retired or disabled	34 27.9%	38 30.9%
Yes	62 50.8%	55 44.7%
No, not yet recovered from surgery	3 2.5%	2 1.6%
No, other reason	1 0.8%	3 2.4%
Retired or disabled	35 28.7%	34 27.6%
Yes	66 54.1%	52 42.3%
No, not yet recovered from surgery	3 2.5%	4 3.3%
No, other reason	1 0.8%	2 1.6%
Retired or disabled	31 25.4%	36 29.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telehealth With Pelvic Floor Muscle Training, Telehealth Without Pelvic Floor Muscle Training
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments	P values not adjusted for multiple comparisons
	Method	Chi-squared, Corrected
	Comments
Other Statistical Analysis		Frequencies for the telehealth and no telehealth groups on the Return to Work question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 52.3% (Yes), 5.0% (No, not yet recovered from surgery), 1.9% (No, other reason), and 40.7% (Retired or disabled) and in the telehealth group were 62.3%, 3.5%, 0.8%, and 33.5% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 4 levels of the Return to Work question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.

12. Secondary Outcome

Title	Resumption of Normal Activity
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Telehealth With Pelvic Floor Muscle Training	Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.	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.
Measure Participants	101	94
None	5 4.1%	7 5.7%
Some	23 18.9%	28 22.8%
All	73 59.8%	59 48%
None	4 3.3%	5 4.1%
Some	19 15.6%	19 15.4%
All	78 63.9%	70 56.9%
None	4 3.3%	3 2.4%
Some	16 13.1%	17 13.8%
All	81 66.4%	74 60.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telehealth With Pelvic Floor Muscle Training, Telehealth Without Pelvic Floor Muscle Training
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.41
	Comments	P values not corrected for multiple comparisons
	Method	Chi-squared, Corrected
	Comments
Other Statistical Analysis		Frequencies for the telehealth and no telehealth groups on the Resumption of Normal Activities question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 7.4% (None), 29.8% (Some), 62.8% (All) and in the telehealth group were 4.9%, 23.0%, and 72.2% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the Resumption of Normal Activities question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.

Adverse Events

Time Frame	12 months
Arm/Group Title	Telehealth With Pelvic Floor Muscle Training		Telehealth Without Pelvic Floor Muscle Training
Arm/Group Description	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.		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.
All Cause Mortality
	Telehealth With Pelvic Floor Muscle Training		Telehealth Without Pelvic Floor Muscle Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/101 (0%)		1/96 (1%)
Serious Adverse Events
	Telehealth With Pelvic Floor Muscle Training		Telehealth Without Pelvic Floor Muscle Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/101 (0%)		1/96 (1%)
General disorders
Death	0/101 (0%)		1/96 (1%)
Other (Not Including Serious) Adverse Events
	Telehealth With Pelvic Floor Muscle Training		Telehealth Without Pelvic Floor Muscle Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/101 (0%)		1/96 (1%)
Surgical and medical procedures
Complications of surgery	0/101 (0%)		1/96 (1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.