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Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01960998
Acronym
ProsTel
Enrollment
245
Registered
2013-10-11
Start date
2014-08-11
Completion date
2019-09-30
Last updated
2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Urinary Incontinence

Keywords

radical prostatectomy, urinary incontinence, prostate cancer, telehealth, pelvic floor muscle training

Brief summary

Many men develop urine leakage after prostate cancer surgery. Usually it is temporary, but pelvic floor muscle training and exercise (including urine control strategies) have been shown to reduce the time to regaining urine control. This study tests an evidence-based, pelvic floor muscle training program that has been adapted to telehealth format and pilot tested in a VA-funded pilot/developmental trial. Training is begun 1-4 weeks before surgery and continued 6 months after surgery. Content is accessed on a secure website in daily 10-minute sessions which transition to weekly sessions for post-operative months 3-6. In the investigators' pilot study, Veterans reported that they appreciated receiving the training in the privacy of their homes, enjoyed the interactive style of the learning experience, and felt better prepared to deal with urine leakage and empowered with new knowledge and skills to help themselves. Content for both control and treatment groups includes general information about prostate cancer; perioperative care; wetness, odor and skin care management. The treatment group will ALSO receive pelvic floor muscle training and bladder control strategies. Outcomes are measured with brief validated questions administered by the telehealth platform, and again at 9 and 12 months by mailed questionnaire or the telehealth platform.

Detailed description

Many men develop urine leakage after radical prostatectomy. Usually it is temporary, but pelvic floor muscle training including bladder control strategies has been shown to reduce the severity of incontinence and reduce the time to regaining continence. This study will test an evidence-based pelvic floor muscle training program that has been adapted to telehealth format and pilot tested in a VA-funded pilot/developmental trial. Training is begun 1-4 weeks before surgery and continued 6 months after surgery. Content is accessed on a secure website in daily 10-minute sessions which transition to weekly sessions for post-operative months 3-6. In the investigators' pilot study, Veterans reported that they appreciated receiving the training in the privacy of their homes, enjoyed the interactive style of the learning experience, and felt better prepared to deal with urine leakage and empowered with new knowledge and skills to help themselves. This study is a randomized, controlled trial of the telehealth-delivered, evidence-based, intervention developed in the pilot/developmental study. Participants will be randomized 1:1 to treatment or to a control group. Content for both control and treatment groups includes general information about prostate cancer; perioperative care; wetness, odor and skin care management. The treatment group will ALSO receive pelvic floor muscle training and bladder control strategies. Outcomes are measured with brief validated questions administered by the telehealth platform, and again at 9 and 12 months by mailed questionnaire or the telehealth platform.

Interventions

BEHAVIORALPelvic 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

BEHAVIORALPerioperative 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED
Emory University
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
University of Alabama at Birmingham
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
MALE
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

Design outcomes

Primary

MeasureTime frameDescription
Time to Continence6 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.

Secondary

MeasureTime frameDescription
Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)6 months, 9 months, 12 monthsThis measure, validated as a stand-alone assessment, consists of 4 questions from the full Expanded Prostate Cancer Index (EPIC), a health-related quality of life assessment tool. The EPIC was developed based on advice from an expert panel and prostate cancer survivors, expanding the 20-item University of California - Los Angeles Prostate Cancer Index. Scores range from 0-100; higher scores indicate worse condition.
Incontinence Impact Questionnaire - Short Form (IIQ-SF)6 months, 9 months, 12 monthsThis measure, validated in men with post-prostatectomy incontinence, measures the impact of incontinence on regular activities. It is a condition-specific quality of life measure that has been widely used in incontinence clinical trials. There are seven items. Response options are: not at all, slightly, moderately, greatly. Scores range from 0-100; higher scores indicate greater impact.
International Prostate Symptom Scale - Quality of Life Question6 months, 9 months, 12 monthsValidated single question: If you were to spend the rest of your life with your urinary problem the way it is now, how would you feel about that? Response options: delighted, pleased, mostly satisfied, mixed (about equally satisfied and dissatisfied), mostly dissatisfied, unhappy, terrible.
Patient Satisfaction Question (PSQ)6 months, 9 months, 12 monthsPatient's rating of satisfaction (Completely satisfied, Somewhat satisfied, Not at all satisfied)
Estimated Percent Improvement (EPI)6 months, 9 months, 12 monthsParticipant self-report of perceived percent improvement from 0% to 100%
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score6 months, 9 months, 12 monthsInternational Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form total score. Scores range from 0-21; higher scores indicate worse condition.
How Disturbing is Urine Leakage6 months, 9 months, 12 monthsSingle quality of life question: How disturbing is the urine leakage problem to you? (not at all, somewhat, or extremely disturbing)
Activity Restriction6 months, 9 months, 12 monthsSingle quality of life question: How much does leakage of urine restrict your activities? (not at all, some of the time, most of the time, all of the time).
Return to Work6 months, 9 months, 12 monthsSingle quality of life question: Have you been able to return to work since your surgery? (yes, no, retired or disabled)
Resumption of Normal Activity6 months, 9 months, 12 monthsSingle quality of life question: Have you been able to resume your usual activities since your surgery? (yes, no)
Global Perception of Improvement (GPI)6 months, 9 months, 12 monthsParticipant's global perception of their improvement (Much better, Better, About the same, Worse, Much worse)

Countries

United States

Participant flow

Recruitment details

245 participants were enrolled in the trial, but only 197 received the assigned intervention. 9 did not have the planned prostatectomy; 39 never started the assigned intervention.

Participants by arm

ArmCount
Telehealth With Pelvic Floor Muscle Training
Participants in this group will participate in an evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively. In addition to the pelvic floor muscle training, content will also include general perioperative care; wetness, odor and skin care management; and outcome measures. Pelvic Floor Muscle Training: Evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in daily 10-minute sessions on a secure website Perioperative Care and Wetness Management: Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.
122
Telehealth Without Pelvic Floor Muscle Training
Participants in this group will receive a telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively. Perioperative Care and Wetness Management: Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.
123
Total245

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath01
Overall Studylost computer access01
Overall StudyLost to Follow-up37
Overall StudyWithdrawal by Subject82

Baseline characteristics

CharacteristicTelehealth With Pelvic Floor Muscle TrainingTotalTelehealth Without Pelvic Floor Muscle Training
Age, Continuous61.9 years
STANDARD_DEVIATION 7.8
61.7 years
STANDARD_DEVIATION 7.4
61.7 years
STANDARD_DEVIATION 7.1
Anxiety
Missing
1 Participants1 Participants0 Participants
Anxiety
No
111 Participants213 Participants102 Participants
Anxiety
Yes
10 Participants31 Participants21 Participants
Asthma, COPD
No
108 Participants221 Participants113 Participants
Asthma, COPD
Yes
14 Participants24 Participants10 Participants
Body mass index28.2 kg/m^2
STANDARD_DEVIATION 4.61
28.9 kg/m^2
STANDARD_DEVIATION 4.6
29.6 kg/m^2
STANDARD_DEVIATION 4.54
Degenerative disc disease
Don't know
1 Participants1 Participants0 Participants
Degenerative disc disease
No
103 Participants199 Participants96 Participants
Degenerative disc disease
Yes
18 Participants45 Participants27 Participants
Depression
No
103 Participants205 Participants102 Participants
Depression
Yes
19 Participants40 Participants21 Participants
Diabetes
No
98 Participants207 Participants109 Participants
Diabetes
Yes
24 Participants38 Participants14 Participants
Education
College or beyond
82 Participants167 Participants85 Participants
Education
< High school
1 Participants3 Participants2 Participants
Education
HS or GED
39 Participants75 Participants36 Participants
Employment
Employed
69 Participants144 Participants75 Participants
Employment
Retired, disabled, or unemployed
53 Participants101 Participants48 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants2 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
122 Participants243 Participants121 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Gleason score
< 7
32 Participants68 Participants36 Participants
Gleason score
> or =7
90 Participants177 Participants87 Participants
Heart failure
No
121 Participants241 Participants120 Participants
Heart failure
Yes
1 Participants4 Participants3 Participants
Living situation
Live alone
14 Participants24 Participants10 Participants
Living situation
Live with family
104 Participants213 Participants109 Participants
Living situation
Other
4 Participants8 Participants4 Participants
Neurological disease
No
119 Participants239 Participants120 Participants
Neurological disease
Yes
3 Participants6 Participants3 Participants
Neurovascular bundle sparing
Both spared
93 Participants192 Participants99 Participants
Neurovascular bundle sparing
Missing
14 Participants30 Participants16 Participants
Neurovascular bundle sparing
None spared
7 Participants11 Participants4 Participants
Neurovascular bundle sparing
One spared
8 Participants12 Participants4 Participants
Prostate specific antigen (PSA), ng/mL
< 10
3 Participants11 Participants8 Participants
Prostate specific antigen (PSA), ng/mL
> or +10
119 Participants234 Participants115 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants3 Participants1 Participants
Race (NIH/OMB)
Black or African American
38 Participants65 Participants27 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
82 Participants177 Participants95 Participants
Region of Enrollment
United States
122 participants245 participants123 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
122 Participants245 Participants123 Participants
Smoking status
Current smoker
14 Participants23 Participants9 Participants
Smoking status
Former smoker
46 Participants88 Participants42 Participants
Smoking status
Never smoked
62 Participants134 Participants72 Participants
Stroke or TIA
No
117 Participants238 Participants121 Participants
Stroke or TIA
Yes
5 Participants7 Participants2 Participants
Surgical approach
Missing
12 Participants22 Participants10 Participants
Surgical approach
Perineal
8 Participants24 Participants16 Participants
Surgical approach
Retropubic
102 Participants199 Participants97 Participants
Surgical technique
Missing
11 Participants19 Participants8 Participants
Surgical technique
Open
5 Participants9 Participants4 Participants
Surgical technique
Robotic
106 Participants217 Participants111 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1011 / 96
other
Total, other adverse events
0 / 1011 / 96
serious
Total, serious adverse events
0 / 1011 / 96

Outcome results

Primary

Time to Continence

Time to continence was based on the time point at which participants reported no urinary incontinence on the International Consultation on Incontinence (ICI) Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). ICIQ-UI SF is one of a series of ICI questionnaires that have been meticulously developed and tested. The ICIQ-UI SF is a brief (4 items), reliable (Cronbach's alpha = 0.95), questionnaire that quantifies both symptom burden and impact of incontinence and has been validated in men and women. It was administered weekly during the 6 months after surgery. Scores range from 0-21; higher scores indicate worse condition.

Time frame: 6 months

ArmMeasureValue (MEDIAN)
Telehealth With Pelvic Floor Muscle TrainingTime to ContinenceNA weeks
Telehealth Without Pelvic Floor Muscle TrainingTime to ContinenceNA weeks
p-value: 0.22Log Rank
Secondary

Activity Restriction

Single quality of life question: How much does leakage of urine restrict your activities? (not at all, some of the time, most of the time, all of the time).

Time frame: 6 months, 9 months, 12 months

Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Telehealth With Pelvic Floor Muscle TrainingActivity Restriction9 monthsAll of the time5 Participants
Telehealth With Pelvic Floor Muscle TrainingActivity Restriction12 monthsNot at all74 Participants
Telehealth With Pelvic Floor Muscle TrainingActivity Restriction12 monthsSome of the time19 Participants
Telehealth With Pelvic Floor Muscle TrainingActivity Restriction12 monthsMost of the time4 Participants
Telehealth With Pelvic Floor Muscle TrainingActivity Restriction12 monthsAll of the time4 Participants
Telehealth With Pelvic Floor Muscle TrainingActivity Restriction6 monthsNot at all57 Participants
Telehealth With Pelvic Floor Muscle TrainingActivity Restriction6 monthsSome of the time34 Participants
Telehealth With Pelvic Floor Muscle TrainingActivity Restriction6 monthsMost of the time4 Participants
Telehealth With Pelvic Floor Muscle TrainingActivity Restriction6 monthsAll of the time6 Participants
Telehealth With Pelvic Floor Muscle TrainingActivity Restriction9 monthsNot at all70 Participants
Telehealth With Pelvic Floor Muscle TrainingActivity Restriction9 monthsSome of the time25 Participants
Telehealth With Pelvic Floor Muscle TrainingActivity Restriction9 monthsMost of the time1 Participants
Telehealth Without Pelvic Floor Muscle TrainingActivity Restriction9 monthsSome of the time23 Participants
Telehealth Without Pelvic Floor Muscle TrainingActivity Restriction9 monthsAll of the time4 Participants
Telehealth Without Pelvic Floor Muscle TrainingActivity Restriction6 monthsSome of the time34 Participants
Telehealth Without Pelvic Floor Muscle TrainingActivity Restriction12 monthsNot at all65 Participants
Telehealth Without Pelvic Floor Muscle TrainingActivity Restriction9 monthsNot at all63 Participants
Telehealth Without Pelvic Floor Muscle TrainingActivity Restriction12 monthsSome of the time17 Participants
Telehealth Without Pelvic Floor Muscle TrainingActivity Restriction6 monthsMost of the time7 Participants
Telehealth Without Pelvic Floor Muscle TrainingActivity Restriction12 monthsMost of the time7 Participants
Telehealth Without Pelvic Floor Muscle TrainingActivity Restriction9 monthsMost of the time4 Participants
Telehealth Without Pelvic Floor Muscle TrainingActivity Restriction12 monthsAll of the time5 Participants
Telehealth Without Pelvic Floor Muscle TrainingActivity Restriction6 monthsAll of the time5 Participants
Telehealth Without Pelvic Floor Muscle TrainingActivity Restriction6 monthsNot at all48 Participants
p-value: 0.63Chi-squared, Corrected
Secondary

Estimated Percent Improvement (EPI)

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

Time frame: 6 months, 9 months, 12 months

Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.

ArmMeasureGroupValue (MEAN)Dispersion
Telehealth With Pelvic Floor Muscle TrainingEstimated Percent Improvement (EPI)6 months69.6 percent improvementStandard Deviation 29.6
Telehealth With Pelvic Floor Muscle TrainingEstimated Percent Improvement (EPI)9 months76.0 percent improvementStandard Deviation 26.2
Telehealth With Pelvic Floor Muscle TrainingEstimated Percent Improvement (EPI)12 months77.4 percent improvementStandard Deviation 28.7
Telehealth Without Pelvic Floor Muscle TrainingEstimated Percent Improvement (EPI)6 months65.1 percent improvementStandard Deviation 34.5
Telehealth Without Pelvic Floor Muscle TrainingEstimated Percent Improvement (EPI)9 months72.6 percent improvementStandard Deviation 31.8
Telehealth Without Pelvic Floor Muscle TrainingEstimated Percent Improvement (EPI)12 months75.7 percent improvementStandard Deviation 28.8
p-value: 0.67t-test, 2 sided
Secondary

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

This measure, validated as a stand-alone assessment, consists of 4 questions from the full Expanded Prostate Cancer Index (EPIC), a health-related quality of life assessment tool. The EPIC was developed based on advice from an expert panel and prostate cancer survivors, expanding the 20-item University of California - Los Angeles Prostate Cancer Index. Scores range from 0-100; higher scores indicate worse condition.

Time frame: 6 months, 9 months, 12 months

Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.

ArmMeasureGroupValue (MEAN)Dispersion
Telehealth With Pelvic Floor Muscle TrainingExpanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)6 months63.9 score on a scaleStandard Deviation 22.1
Telehealth With Pelvic Floor Muscle TrainingExpanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)9 months67.7 score on a scaleStandard Deviation 21.2
Telehealth With Pelvic Floor Muscle TrainingExpanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)12 months70.4 score on a scaleStandard Deviation 20.4
Telehealth Without Pelvic Floor Muscle TrainingExpanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)6 months63.5 score on a scaleStandard Deviation 24.1
Telehealth Without Pelvic Floor Muscle TrainingExpanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)9 months65.1 score on a scaleStandard Deviation 26.2
Telehealth Without Pelvic Floor Muscle TrainingExpanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)12 months68.0 score on a scaleStandard Deviation 25.3
p-value: 0.7ANCOVA
Secondary

Global Perception of Improvement (GPI)

Participant's global perception of their improvement (Much better, Better, About the same, Worse, Much worse)

Time frame: 6 months, 9 months, 12 months

Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)6 monthsMuch worse3 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)9 monthsBetter45 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)12 monthsAbout the same12 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)9 monthsAbout the same9 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)6 monthsBetter41 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)9 monthsWorse3 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)9 monthsMuch better41 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)9 monthsMuch worse3 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)6 monthsAbout the same15 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)12 monthsMuch better51 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)12 monthsWorse2 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)12 monthsBetter31 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)6 monthsWorse3 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)12 monthsMuch worse5 Participants
Telehealth With Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)6 monthsMuch better39 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)12 monthsMuch worse4 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)9 monthsMuch better43 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)12 monthsBetter25 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)12 monthsAbout the same19 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)6 monthsMuch better43 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)6 monthsBetter29 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)6 monthsAbout the same16 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)6 monthsWorse2 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)9 monthsBetter29 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)9 monthsAbout the same15 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)9 monthsWorse4 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)9 monthsMuch worse3 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)12 monthsMuch better43 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)12 monthsWorse3 Participants
Telehealth Without Pelvic Floor Muscle TrainingGlobal Perception of Improvement (GPI)6 monthsMuch worse4 Participants
p-value: 0.65Chi-squared, Corrected
Secondary

How Disturbing is Urine Leakage

Single quality of life question: How disturbing is the urine leakage problem to you? (not at all, somewhat, or extremely disturbing)

Time frame: 6 months, 9 months, 12 months

Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Telehealth With Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage6 monthsSomewhat54 Participants
Telehealth With Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage9 monthsExtremely6 Participants
Telehealth With Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage6 monthsNot at all39 Participants
Telehealth With Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage12 monthsNot at all43 Participants
Telehealth With Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage6 monthsExtremely8 Participants
Telehealth With Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage12 monthsSomewhat51 Participants
Telehealth With Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage9 monthsSomewhat53 Participants
Telehealth With Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage12 monthsExtremely7 Participants
Telehealth With Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage9 monthsNot at all42 Participants
Telehealth Without Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage12 monthsExtremely11 Participants
Telehealth Without Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage9 monthsNot at all42 Participants
Telehealth Without Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage6 monthsNot at all41 Participants
Telehealth Without Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage6 monthsSomewhat42 Participants
Telehealth Without Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage6 monthsExtremely11 Participants
Telehealth Without Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage9 monthsSomewhat45 Participants
Telehealth Without Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage9 monthsExtremely7 Participants
Telehealth Without Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage12 monthsNot at all49 Participants
Telehealth Without Pelvic Floor Muscle TrainingHow Disturbing is Urine Leakage12 monthsSomewhat34 Participants
p-value: 0.37Chi-squared, Corrected
Secondary

Incontinence Impact Questionnaire - Short Form (IIQ-SF)

This measure, validated in men with post-prostatectomy incontinence, measures the impact of incontinence on regular activities. It is a condition-specific quality of life measure that has been widely used in incontinence clinical trials. There are seven items. Response options are: not at all, slightly, moderately, greatly. Scores range from 0-100; higher scores indicate greater impact.

Time frame: 6 months, 9 months, 12 months

Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.

ArmMeasureGroupValue (MEAN)Dispersion
Telehealth With Pelvic Floor Muscle TrainingIncontinence Impact Questionnaire - Short Form (IIQ-SF)6 months19.4 score on a scaleStandard Deviation 22.4
Telehealth With Pelvic Floor Muscle TrainingIncontinence Impact Questionnaire - Short Form (IIQ-SF)9 months15.2 score on a scaleStandard Deviation 21.4
Telehealth With Pelvic Floor Muscle TrainingIncontinence Impact Questionnaire - Short Form (IIQ-SF)12 months13.5 score on a scaleStandard Deviation 20.7
Telehealth Without Pelvic Floor Muscle TrainingIncontinence Impact Questionnaire - Short Form (IIQ-SF)6 months22.3 score on a scaleStandard Deviation 24.1
Telehealth Without Pelvic Floor Muscle TrainingIncontinence Impact Questionnaire - Short Form (IIQ-SF)9 months19.3 score on a scaleStandard Deviation 24.9
Telehealth Without Pelvic Floor Muscle TrainingIncontinence Impact Questionnaire - Short Form (IIQ-SF)12 months16.5 score on a scaleStandard Deviation 23.7
p-value: 0.46t-test, 2 sided
Secondary

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

International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form total score. Scores range from 0-21; higher scores indicate worse condition.

Time frame: 6 months, 9 months, 12 months

Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.

ArmMeasureGroupValue (MEAN)Dispersion
Telehealth With Pelvic Floor Muscle TrainingInternational Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score6 months7.1 score on a scaleStandard Deviation 4.3
Telehealth With Pelvic Floor Muscle TrainingInternational Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score9 months6.2 score on a scaleStandard Deviation 3.9
Telehealth With Pelvic Floor Muscle TrainingInternational Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score12 months5.9 score on a scaleStandard Deviation 4.1
Telehealth Without Pelvic Floor Muscle TrainingInternational Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score6 months7.0 score on a scaleStandard Deviation 4.4
Telehealth Without Pelvic Floor Muscle TrainingInternational Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score9 months6.7 score on a scaleStandard Deviation 5.1
Telehealth Without Pelvic Floor Muscle TrainingInternational Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score12 months6.0 score on a scaleStandard Deviation 4.7
p-value: 0.7ANCOVA
Secondary

International Prostate Symptom Scale - Quality of Life Question

Validated single question: If you were to spend the rest of your life with your urinary problem the way it is now, how would you feel about that? Response options: delighted, pleased, mostly satisfied, mixed (about equally satisfied and dissatisfied), mostly dissatisfied, unhappy, terrible.

Time frame: 6 months, 9 months, 12 months

Population: In both arms, the Outcome Measure Data Table reflects the average frequencies across 10 multiple imputations, so the sum of individual frequencies may not exactly equal the total number of participants due to rounding. Two individuals were missing all outcome measures; their data were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question9 months Mostly satisfied22 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question9 months Mostly dissatisfied12 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question6 months Mostly satisfied27 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question9 months Unhappy/Terrible11 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question9 months Delighted/Pleased36 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question12 months Delighted/Pleased41 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question6 months Mixed27 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question12 months Mostly satisfied28 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question6 months Unhappy/Terrible14 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question12 months Mixed17 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question6 months Mostly dissatisfied13 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question12 months Mostly dissatistied9 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question9 months Mixed20 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question12 months Unhappy/Terrible6 Participants
Telehealth With Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question6 months Delighted/Pleased21 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question12 months Unhappy/Terrible10 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question6 months Delighted/Pleased30 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question6 months Mostly dissatisfied11 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question6 months Unhappy/Terrible14 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question9 months Delighted/Pleased32 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question9 months Mostly satisfied27 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question6 months Mostly satisfied21 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question6 months Mixed18 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question9 months Mixed9 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question9 months Mostly dissatisfied10 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question9 months Unhappy/Terrible16 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question12 months Delighted/Pleased39 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question12 months Mostly satisfied25 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question12 months Mixed12 Participants
Telehealth Without Pelvic Floor Muscle TrainingInternational Prostate Symptom Scale - Quality of Life Question12 months Mostly dissatistied8 Participants
p-value: 0.63Chi-squared, Corrected
Secondary

Patient Satisfaction Question (PSQ)

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

Time frame: 6 months, 9 months, 12 months

Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group. The frequencies for both Telehealth With and Without Pelvic Floor Muscle Training were calculated across 10 multiple imputations and rounded to the nearest whole number, so sum of individual categories (102) does not equal overall number of participants (101).

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Telehealth With Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)6 monthsSomewhat satisfied61 Participants
Telehealth With Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)9 monthsNot at all satisfied4 Participants
Telehealth With Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)9 monthsCompletely satisfied44 Participants
Telehealth With Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)12 monthsCompletely satisfied54 Participants
Telehealth With Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)6 monthsNot at all satisfied5 Participants
Telehealth With Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)12 monthsSomewhat satisfied42 Participants
Telehealth With Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)9 monthsSomewhat satisfied53 Participants
Telehealth With Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)12 monthsNot at all satisfied5 Participants
Telehealth With Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)6 monthsCompletely satisfied35 Participants
Telehealth Without Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)12 monthsNot at all satisfied10 Participants
Telehealth Without Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)6 monthsCompletely satisfied48 Participants
Telehealth Without Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)6 monthsSomewhat satisfied38 Participants
Telehealth Without Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)6 monthsNot at all satisfied8 Participants
Telehealth Without Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)9 monthsCompletely satisfied46 Participants
Telehealth Without Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)9 monthsSomewhat satisfied37 Participants
Telehealth Without Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)9 monthsNot at all satisfied11 Participants
Telehealth Without Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)12 monthsCompletely satisfied50 Participants
Telehealth Without Pelvic Floor Muscle TrainingPatient Satisfaction Question (PSQ)12 monthsSomewhat satisfied34 Participants
p-value: 0.04Chi-squared, Corrected
Secondary

Resumption of Normal Activity

Single quality of life question: Have you been able to resume your usual activities since your surgery? (yes, no)

Time frame: 6 months, 9 months, 12 months

Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Telehealth With Pelvic Floor Muscle TrainingResumption of Normal Activity6 monthsAll73 Participants
Telehealth With Pelvic Floor Muscle TrainingResumption of Normal Activity12 monthsNone4 Participants
Telehealth With Pelvic Floor Muscle TrainingResumption of Normal Activity9 monthsSome19 Participants
Telehealth With Pelvic Floor Muscle TrainingResumption of Normal Activity12 monthsSome16 Participants
Telehealth With Pelvic Floor Muscle TrainingResumption of Normal Activity9 monthsNone4 Participants
Telehealth With Pelvic Floor Muscle TrainingResumption of Normal Activity12 monthsAll81 Participants
Telehealth With Pelvic Floor Muscle TrainingResumption of Normal Activity9 monthsAll78 Participants
Telehealth With Pelvic Floor Muscle TrainingResumption of Normal Activity6 monthsNone5 Participants
Telehealth With Pelvic Floor Muscle TrainingResumption of Normal Activity6 monthsSome23 Participants
Telehealth Without Pelvic Floor Muscle TrainingResumption of Normal Activity6 monthsNone7 Participants
Telehealth Without Pelvic Floor Muscle TrainingResumption of Normal Activity6 monthsSome28 Participants
Telehealth Without Pelvic Floor Muscle TrainingResumption of Normal Activity6 monthsAll59 Participants
Telehealth Without Pelvic Floor Muscle TrainingResumption of Normal Activity9 monthsNone5 Participants
Telehealth Without Pelvic Floor Muscle TrainingResumption of Normal Activity9 monthsSome19 Participants
Telehealth Without Pelvic Floor Muscle TrainingResumption of Normal Activity9 monthsAll70 Participants
Telehealth Without Pelvic Floor Muscle TrainingResumption of Normal Activity12 monthsNone3 Participants
Telehealth Without Pelvic Floor Muscle TrainingResumption of Normal Activity12 monthsSome17 Participants
Telehealth Without Pelvic Floor Muscle TrainingResumption of Normal Activity12 monthsAll74 Participants
p-value: 0.41Chi-squared, Corrected
Secondary

Return to Work

Single quality of life question: Have you been able to return to work since your surgery? (yes, no, retired or disabled)

Time frame: 6 months, 9 months, 12 months

Population: Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Telehealth With Pelvic Floor Muscle TrainingReturn to Work6 monthsRetired or disabled34 Participants
Telehealth With Pelvic Floor Muscle TrainingReturn to Work12 monthsNo, not yet recovered from surgery3 Participants
Telehealth With Pelvic Floor Muscle TrainingReturn to Work6 monthsNo, other reason1 Participants
Telehealth With Pelvic Floor Muscle TrainingReturn to Work9 monthsYes62 Participants
Telehealth With Pelvic Floor Muscle TrainingReturn to Work9 monthsNo, not yet recovered from surgery3 Participants
Telehealth With Pelvic Floor Muscle TrainingReturn to Work9 monthsRetired or disabled35 Participants
Telehealth With Pelvic Floor Muscle TrainingReturn to Work9 monthsNo, other reason1 Participants
Telehealth With Pelvic Floor Muscle TrainingReturn to Work6 monthsNo, not yet recovered from surgery3 Participants
Telehealth With Pelvic Floor Muscle TrainingReturn to Work12 monthsNo, other reason1 Participants
Telehealth With Pelvic Floor Muscle TrainingReturn to Work12 monthsYes66 Participants
Telehealth With Pelvic Floor Muscle TrainingReturn to Work12 monthsRetired or disabled31 Participants
Telehealth With Pelvic Floor Muscle TrainingReturn to Work6 monthsYes63 Participants
Telehealth Without Pelvic Floor Muscle TrainingReturn to Work12 monthsRetired or disabled36 Participants
Telehealth Without Pelvic Floor Muscle TrainingReturn to Work6 monthsYes49 Participants
Telehealth Without Pelvic Floor Muscle TrainingReturn to Work6 monthsNo, not yet recovered from surgery5 Participants
Telehealth Without Pelvic Floor Muscle TrainingReturn to Work6 monthsNo, other reason2 Participants
Telehealth Without Pelvic Floor Muscle TrainingReturn to Work6 monthsRetired or disabled38 Participants
Telehealth Without Pelvic Floor Muscle TrainingReturn to Work9 monthsRetired or disabled34 Participants
Telehealth Without Pelvic Floor Muscle TrainingReturn to Work12 monthsYes52 Participants
Telehealth Without Pelvic Floor Muscle TrainingReturn to Work12 monthsNo, not yet recovered from surgery4 Participants
Telehealth Without Pelvic Floor Muscle TrainingReturn to Work9 monthsYes55 Participants
Telehealth Without Pelvic Floor Muscle TrainingReturn to Work9 monthsNo, not yet recovered from surgery2 Participants
Telehealth Without Pelvic Floor Muscle TrainingReturn to Work9 monthsNo, other reason3 Participants
Telehealth Without Pelvic Floor Muscle TrainingReturn to Work12 monthsNo, other reason2 Participants
p-value: 0.71Chi-squared, Corrected

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026