Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

Not Applicable

Completed

• Conditions: Urinary Incontinence; Prostate Cancer
• Interventions: Behavioral: Pelvic Floor Muscle Training; Behavioral: Perioperative Care and Wetness Management

• Registration Number: NCT01960998
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2013-10-04
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Study Start: 2014-08-11
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Results First Submitted: 2021-04-26
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-14
• Last Update Submitted: 2021-07-14
• Results First Posted: 2021-08-09
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 245

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

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Exclusion Criteria

• Urinary Incontinence in the 6 months prior to prostate cancer surgery (other than post-void dribbling)
• Less than 1 week before surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
Estimated Percent Improvement (EPI)	6 months, 9 months, 12 months	Participant self-report of perceived percent improvement from 0% to 100%
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)
Incontinence Impact Questionnaire - Short Form (IIQ-SF)	6 months, 9 months, 12 months	This measure, validated in men with post-prostatectomy incontinence, measures the impact of incontinence on regular activities. It is a condition-specific quality of life measure that has been widely used in incontinence clinical trials. There are seven items. Response options are: "not at all," "slightly," "moderately," "greatly." Scores range from 0-100; higher scores indicate greater impact.
International Prostate Symptom Scale - Quality of Life Question	6 months, 9 months, 12 months	Validated single question: "If you were to spend the rest of your life with your urinary problem the way it is now, how would you feel about that?" Response options: delighted, pleased, mostly satisfied, mixed (about equally satisfied and dissatisfied), mostly dissatisfied, unhappy, terrible.
Patient Satisfaction Question (PSQ)	6 months, 9 months, 12 months	Patient's rating of satisfaction (Completely satisfied, Somewhat satisfied, Not at all satisfied)
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)
How Disturbing is Urine Leakage	6 months, 9 months, 12 months	Single quality of life question: "How disturbing is the urine leakage problem to you?" (not at all, somewhat, or extremely disturbing)
Activity Restriction	6 months, 9 months, 12 months	Single quality of life question: "How much does leakage of urine restrict your activities?" (not at all, some of the time, most of the time, all of the time).
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)

Trial Locations

Locations (3)

Atlanta VA Medical and Rehab Center, Decatur, GA; 🇺🇸 Decatur, Georgia, United States

Philadelphia VA Medical Center, Philadelphia, PA; 🇺🇸 Philadelphia, Pennsylvania, United States

Birmingham VA Medical Center; 🇺🇸 Birmingham, Alabama, United States