Perioperative Post-Prostatectomy Incontinence Home Telehealth Program (ProsTel)

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Prostate Cancer
• Intervention / Treatment: Behavioral: Pelvic Floor Muscle Training; Behavioral: Perioperative Care and Wetness Management

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 Type: Interventional
• Enrollment (Actual): 245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Birmingham VA Medical Center
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta VA Medical and Rehab Center, Decatur, GA
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia VA Medical Center, Philadelphia, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of Pennsylvania; University of Alabama at Birmingham; Emory University
• Investigators: Principal Investigator: Kathryn L Burgio, PhD MA BA, Birmingham VA Medical Center, Birmingham, AL

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2014
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: October 4, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: prostate cancer; urinary incontinence; radical prostatectomy; telehealth; pelvic floor muscle training
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Genital Neoplasms, Male; Prostatic Diseases; Urination Disorders; Elimination Disorders; Prostatic Neoplasms; Urinary Incontinence; Enuresis
• Other Study ID Numbers: D1059-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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