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Perioperative Post-Prostatectomy Incontinence Home Telehealth Program (ProsTel)

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ClinicalTrials.gov Identifier: NCT01960998
Recruitment Status : Active, not recruiting
First Posted : October 11, 2013
Last Update Posted : August 3, 2018
Sponsor:
Collaborators:
Emory University
University of Pennsylvania
University of Alabama at Birmingham
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Prostate Cancer Behavioral: Pelvic Floor Muscle Training Behavioral: Perioperative Care and Wetness Management Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Perioperative Post-Prostatectomy Incontinence Home Telehealth Program
Actual Study Start Date : August 11, 2014
Actual Primary Completion Date : June 18, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telehealth with Pelvic Floor Muscle Training
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.
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.

Active Comparator: Telehealth without Pelvic Floor Muscle Training
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.
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.




Primary Outcome Measures :
  1. Time to continence as determined by the International Consultation on Incontinence ICIQ-Short form [ Time Frame: Administered weekly for 6 months and then at 9 and 12 months ]
    The International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) is one of a series of International Consultation on Incontinence questionnaires that have been meticulously developed and tested. The ICI questionnaires are becoming the outcome measures of choice in incontinence clinical trials internationally, allowing comparability between studies. The ICIQ-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.


Secondary Outcome Measures :
  1. ICIQ-SF total score [ Time Frame: monthly for 6 months and then at 9 and 12 months ]
    See primary measure

  2. Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI) [ Time Frame: monthly for 6 months and then at 9 and 12 months ]
    This measure, validated as a stand-alone assessment, consists of 4 questions from the EPIC, a health-related quality of life (HRQOL) 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

  3. Incontinence Impact Questionnaire - Short Form (IIQ-SF) [ Time Frame: monthly for 6 months and then at 9 and 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.

  4. International Prostate Symptom Score - Quality of Life Question [ Time Frame: monthly for 6 months and then at 9 and 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? Delighted, Pleased, Mostly satisfied, Mixed (about equally satisfied and dissatisfied), Mostly dissatisfied, Unhappy, Terrible.

  5. Incontinence-related Quality of Life Questionnaire [ Time Frame: monthly for 6 months and then at 9 and 12 months ]

    Unvalidated descriptive questions that have been used in our previous research:

    • How disturbing is the urine leakage problem to you? (not at all, somewhat, or extremely disturbing)
    • How much does leakage of urine restrict your activities? (not at all, some of the time, most of the time, all of the time).
    • Have you been able to return to work since your surgery? (yes, no, retired or disabled)
    • Have you been able to resume your usual activities since your surgery? (yes, no)

  6. Patient Satisfaction Question (PSQ) [ Time Frame: Monthly for 6 months ]
    Validated outcome measure that reflect patient satisfaction using a Likert scale

  7. Estimated Percent Improvement (EPI), [ Time Frame: Monthly for 6 months and then at 9 and 12 months ]
    Measures of patient-centered outcome assessment - percentage of improvement from 0-100%

  8. Global Perception of Improvement (GPI) [ Time Frame: Monthly for 6 months and then at 9 and 12 months ]
    Measure of patient-centered outcome assessment - patient's global perception of their improvement using a Likert scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men planning surgery for prostate cancer
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960998


Locations
United States, Alabama
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
United States, Pennsylvania
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
VA Office of Research and Development
Emory University
University of Pennsylvania
University of Alabama at Birmingham
Investigators
Principal Investigator: Patricia S Goode, MD MSN BSN Birmingham VA Medical Center, Birmingham, AL

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01960998     History of Changes
Other Study ID Numbers: D1059-R
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
radical prostatectomy
urinary incontinence
prostate cancer
telehealth
pelvic floor muscle training

Additional relevant MeSH terms:
Prostatic Neoplasms
Urinary Incontinence
Enuresis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders