Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

Prostate Cancer Clinical Trial

— ProsTel  

Official title:

Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960998
• Other study ID #: D1059-R
• Status: Completed
• Phase: N/A
• Start date: August 11, 2014
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Prostate Cancer
• Prostatic Neoplasms
• Urinary Incontinence

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Birmingham VA Medical Center	Birmingham	Alabama
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia
United States	Philadelphia VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
VA Office of Research and Development	Emory University, University of Alabama at Birmingham, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 months
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.	6 months, 9 months, 12 months
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.	6 months, 9 months, 12 months
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.	6 months, 9 months, 12 months
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.	6 months, 9 months, 12 months
Secondary	Patient Satisfaction Question (PSQ)	Patient's rating of satisfaction (Completely satisfied, Somewhat satisfied, Not at all satisfied)	6 months, 9 months, 12 months
Secondary	Estimated Percent Improvement (EPI)	Participant self-report of perceived percent improvement from 0% to 100%	6 months, 9 months, 12 months
Secondary	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
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)	6 months, 9 months, 12 months
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).	6 months, 9 months, 12 months
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)	6 months, 9 months, 12 months
Secondary	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