Clinical trial NCT01960998: Perioperative Post-Prostatectomy Incontinence Home Telehealth Program
Official title: Perioperative Post-Prostatectomy Incontinence Home Telehealth Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Prostate Cancer
Keywords: radical prostatectomy
urinary incontinence
prostate cancer
telehealth
pelvic floor muscle training
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Emory University
name: University of Pennsylvania
name: University of Alabama at Birmingham
First posted: 2013-10-11
Enrollment: 245
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: Time to Continence
timeFrame: 6 months
Secondary outcomes:
measure: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score
timeFrame: 6 months, 9 months, 12 months
measure: Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)
timeFrame: 6 months, 9 months, 12 months
measure: Incontinence Impact Questionnaire - Short Form (IIQ-SF)
timeFrame: 6 months, 9 months, 12 months
measure: International Prostate Symptom Scale - Quality of Life Question
timeFrame: 6 months, 9 months, 12 months
measure: Patient Satisfaction Question (PSQ)
timeFrame: 6 months, 9 months, 12 months
measure: Estimated Percent Improvement (EPI)
timeFrame: 6 months, 9 months, 12 months
measure: Global Perception of Improvement (GPI)
timeFrame: 6 months, 9 months, 12 months
measure: How Disturbing is Urine Leakage
timeFrame: 6 months, 9 months, 12 months
measure: Activity Restriction
timeFrame: 6 months, 9 months, 12 months
measure: Return to Work
timeFrame: 6 months, 9 months, 12 months
measure: Resumption of Normal Activity
timeFrame: 6 months, 9 months, 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center
state: Alabama
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Birmingham VA Medical Center, Birmingham, AL
name: Kathryn L Burgio, PhD MA BA
role: PRINCIPAL_INVESTIGATOR
References: