Perioperative Post-Prostatectomy Incontinence Home Telehealth Program



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer, Overactive Bladder, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology, Oncology
Healthy:No
Age Range:Any
Updated:1/11/2019
Start Date:August 11, 2014
End Date:March 29, 2019

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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.

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.

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
We found this trial at
3
sites
Birmingham, Alabama 35233
Principal Investigator: Patricia S Goode, MD MSN BSN
Phone: 205-933-8101
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Decatur, Georgia 30033
Phone: 404-321-6111
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Decatur, GA
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Philadelphia, Pennsylvania 19104
Phone: 215-615-3459
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Philadelphia, PA
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