Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

NCT01960998 | Completed Results

• 1 other identifier: D1059-R
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 3

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.

Conditions

Urinary Incontinence; Prostate Cancer

Keywords

radical prostatectomy; urinary incontinence; prostate cancer; telehealth; pelvic floor muscle training

Outcome Measures

Primary Outcomes (1)

• Time to Continence

  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.

  6 months

Secondary Outcomes (11)

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

  6 months, 9 months, 12 months

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

  6 months, 9 months, 12 months

• Incontinence Impact Questionnaire - Short Form (IIQ-SF)

  6 months, 9 months, 12 months

• International Prostate Symptom Scale - Quality of Life Question

  6 months, 9 months, 12 months

• Patient Satisfaction Question (PSQ)

  6 months, 9 months, 12 months

Study Arms (2)

Telehealth with Pelvic Floor Muscle Training

EXPERIMENTAL

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; Behavioral: Perioperative Care and Wetness Management

Telehealth without Pelvic Floor Muscle Training

ACTIVE COMPARATOR

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

Interventions

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

Telehealth with Pelvic Floor Muscle Training

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.

Telehealth with Pelvic Floor Muscle Training; Telehealth without Pelvic Floor Muscle Training

Eligibility Criteria

• Gender Eligibility Details: Men planning surgery for prostate cancer
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Urinary Incontinence in the 6 months prior to prostate cancer surgery (other than post-void dribbling)
• Less than 1 week before surgery

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Emory University: collaborator
• University of Pennsylvania: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (3)

Birmingham VA Medical Center

Birmingham, Alabama, 35233, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Prostatic Neoplasms

Interventions

Perioperative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Kathryn L. Burgio, PhD
• Organization: Birmingham VA Medcial Center

kburgio@uabmc.edu

205-999-9537

Study Officials

• Kathryn L Burgio, PhD MA BA

  Birmingham VA Medical Center, Birmingham, AL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 11, 2013
• Study Start: August 11, 2014
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: August 9, 2021
• Results First Posted: August 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)