Perioperative Post-Prostatectomy Incontinence Home Telehealth Program
Conditions
Urinary Incontinence - Prostate Cancer
Conditions: official terms
Prostatic Neoplasms - Urinary Incontinence
Conditions: Keywords
radical prostatectomy, urinary incontinence, prostate cancer, telehealth, pelvic floor muscle training
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pelvic Floor Muscle Training Type: Behavioral
Name: Perioperative Care and Wetness Management Type: Behavioral
Overall Status
Recruiting
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 month before surgery and continued 6 months after surgery. Content is delivered in daily 10-minute sessions which transition to weekly sessions for post-operative months 3-6. A telehealth device, a simple home messaging unit that is used throughout the VA to help veterans improve their health, provides the sessions. In our pilot study, veterans reported that the home messaging units were easy to set up and use, 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 device, and again at 9 and 12 months by mailed questionnaire.
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 month before surgery and continued 6 months after surgery. Content is delivered in daily 10-minute sessions which transition to weekly sessions for post-operative months 3-6. A telehealth device, a simple home messaging unit that is used throughout the VA to help veterans improve their health, provides the sessions. In our pilot study, veterans reported that the home messaging units were easy to set up and use, 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 device, and again at 9 and 12 months by mailed questionnaire.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: N/A
Gender: Male
Criteria: 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 scheduled to undergo a radical prostatectomy for treatment of prostate cancer at the affiliated University Medical Centers.

- Ability to read English.

- Analog telephone line ("land line") at home OR live in an area where internet access or cell-phone service is available.

Exclusion Criteria:

- Urinary Incontinence in the 6 months prior to prostate cancer surgery (other than post-void dribbling)

- Less than 3 weeks before surgery
Locations
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States
Status: Recruiting
Contact: Kathy J Martin, MA - 205-933-8101 - Kathy.Martin4@va.gov
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States
Status: Recruiting
Contact: Sean Halpin, MA - 404-321-6111 - sean.halpin@va.gov
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Thomas Bavaria - 215-615-3459 - tom.bavaria@uphs.upenn.edu
Start Date
August 2014
Completion Date
September 2017
Sponsors
Department of Veterans Affairs
Source
Department of Veterans Affairs
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page