Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

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.

Conditions

• Urinary Incontinence
• Prostate Cancer

Interventions

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.

Sponsors & Collaborators

• Emory University

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• VA Office of Research and Development

  lead FED

Principal Investigators

• Kathryn L Burgio, PhD MA BA · Birmingham VA Medical Center, Birmingham, AL

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-08-11

Primary Completion

2019-09-30

Completion

2019-09-30

Countries

• United States

Study Locations