Perioperative Post-Prostatectomy Incontinence Home Telehealth Program (ProsTel)

VA Office of Research and Development

Status: Completed

Conditions: Prostate Cancer; Urinary Incontinence

Treatments: Behavioral: Perioperative Care and Wetness Management; Behavioral: Pelvic Floor Muscle Training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01960998

D1059-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 245 patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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245 participants in 2 patient groups

Telehealth with Pelvic Floor Muscle Training

Experimental group

Description:

Participants in this group will participate in an evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1 month 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. In addition to the pelvic floor muscle training, content will also include general perioperative care; wetness, odor and skin care management; and outcome measures.

Treatment:

Behavioral: Pelvic Floor Muscle Training

Behavioral: Perioperative Care and Wetness Management

Telehealth without Pelvic Floor Muscle Training

Active Comparator group

Description:

Participants in this group will receive a telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 3 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.

Treatment:

Behavioral: Perioperative Care and Wetness Management