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Completed

NCT Number: NCT01960998

Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urological Manifestations

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham VA Medical Center, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic floor muscle training

Behavioral

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

Perioperative Care and Wetness Management

Behavioral

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.

Primary outcomes

  1. Time to Continence

    Time frame: 6 months

    Time to continence was based on the time point at which participants reported no urinary incontinence on the International Consultation on Incontinence (ICI) Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). ICIQ-UI SF is one of a series of ICI questionnaires that have been meticulously developed and tested. The ICIQ-UI SF is a brief (4 items), reliable (Cronbach's alpha = 0.95), questionnaire that quantifies both symptom burden and impact of incontinence and has been validated in men and women. It was administered weekly during the 6 months after surgery. Scores range from 0-21; higher scores indicate worse condition.

Secondary outcomes

  1. International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score

    Time frame: 6 months, 9 months, 12 months

    International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form total score. Scores range from 0-21; higher scores indicate worse condition.

  2. Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)

    Time frame: 6 months, 9 months, 12 months

    This measure, validated as a stand-alone assessment, consists of 4 questions from the full Expanded Prostate Cancer Index (EPIC), a health-related quality of life assessment tool. The EPIC was developed based on advice from an expert panel and prostate cancer survivors, expanding the 20-item University of California - Los Angeles Prostate Cancer Index. Scores range from 0-100; higher scores indicate worse condition.

  3. Incontinence Impact Questionnaire - Short Form (IIQ-SF)

    Time frame: 6 months, 9 months, 12 months

    This measure, validated in men with post-prostatectomy incontinence, measures the impact of incontinence on regular activities. It is a condition-specific quality of life measure that has been widely used in incontinence clinical trials. There are seven items. Response options are: "not at all," "slightly," "moderately," "greatly." Scores range from 0-100; higher scores indicate greater impact.

  4. International Prostate Symptom Scale - Quality of Life Question

    Time frame: 6 months, 9 months, 12 months

    Validated single question: "If you were to spend the rest of your life with your urinary problem the way it is now, how would you feel about that?" Response options: delighted, pleased, mostly satisfied, mixed (about equally satisfied and dissatisfied), mostly dissatisfied, unhappy, terrible.

  5. Patient Satisfaction Question (PSQ)

    Time frame: 6 months, 9 months, 12 months

    Patient's rating of satisfaction (Completely satisfied, Somewhat satisfied, Not at all satisfied)

  6. Estimated Percent Improvement (EPI)

    Time frame: 6 months, 9 months, 12 months

    Participant self-report of perceived percent improvement from 0% to 100%

  7. Global Perception of Improvement (GPI)

    Time frame: 6 months, 9 months, 12 months

    Participant's global perception of their improvement (Much better, Better, About the same, Worse, Much worse)

  8. How Disturbing is Urine Leakage

    Time frame: 6 months, 9 months, 12 months

    Single quality of life question: "How disturbing is the urine leakage problem to you?" (not at all, somewhat, or extremely disturbing)

  9. Activity Restriction

    Time frame: 6 months, 9 months, 12 months

    Single quality of life question: "How much does leakage of urine restrict your activities?" (not at all, some of the time, most of the time, all of the time).

  10. Return to Work

    Time frame: 6 months, 9 months, 12 months

    Single quality of life question: "Have you been able to return to work since your surgery?" (yes, no, retired or disabled)

  11. Resumption of Normal Activity

    Time frame: 6 months, 9 months, 12 months

    Single quality of life question: "Have you been able to resume your usual activities since your surgery?" (yes, no)

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Emory University
  • University of Alabama at Birmingham
  • University of Pennsylvania

Registry information

Acronym: ProsTel

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2013
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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