NCT Number: NCT04237753
This study is about assessing the helpfulness of two treatment delivery methods for bladder leakage or urinary incontinence. It is being funded by the Department of Veterans Affairs. By doing this study, the investigators hope to learn which treatment method is the most helpful remote delivery method for treating bladder leakage. The total participation time in this research is 6 months. During the first 8 -12 weeks of the study, you will receive standard of care from an online educational program (MyHealtheBladder) or a video visit with a provider through VA Video Connect. You will be selected by chance to receive MyHealtheBladder or VA Video Connect. About half-way through the study, the investigators will ask you about your bladder symptoms. If your bladder symptoms are not better, you will be selected by chance to continue the previous treatment or receive an initial or booster video session with a provider. Throughout the study, you will be asked to answer questions related to your health, bladder leakage, costs due to bladder leakage, and track your behavioral training.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Birmingham VA Medical Center, Birmingham, AL, Birmingham, Alabama, United States
This study represents a unique opportunity to improve access to treatments for urine leakage for women Veterans. This research study will examine the effects of two mobile health technologies on improving bladder symptoms, as part of a randomized clinical trial. The study includes 260 women Veterans recruited from 3 sites: the Birmingham VAMC, the Atlanta VAHCS, and the Durham VAMC (86 per site). Women will receive first-line treatments for urine leakage through randomization to one of two delivery methods for direct treatment: (1) a web-based mobile health application that delivers content daily for 8 weeks compared to (2) a single video session delivered by VA Video Connect. At 8-weeks, women who do not have improved symptoms will have the ability to continue the treatment or receive an initial or booster video session. The investigators will measure bladder symptoms (3 questions by self-report over the phone or via survey) at baseline, 8-weeks, 12-weeks, and 6-months. Additionally, the investigators will interview 54 women Veterans and 12 providers to learn about their experiences with the technologies using 1:1 telephone interviews at 12-weeks. The findings from this study will inform the best technology to improve access for bladder leakage among women Veterans across a wider array of VHA facilities.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Remote telehealth visits with continence care provider who will provide education on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage
Other names: Telehealth visit with Continence Provider
Daily mobile health education with information on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage
Other names: Mobile health bladder education
Time frame: baseline to 12 weeks
Urinary incontinence severity questionnaire, range 0-21, higher scores represent greater symptom severity
Time frame: baseline to 12-weeks
Overactive bladder symptom severity questionnaire, range 0-12, higher scores represent greater symptoms severity
Time frame: 12-weeks
Patient satisfaction question (PSQ) - 3 categories of response (highly satisfied, satisfied, not satisfied)
Time frame: 12-weeks
Adherence to pelvic floor muscle exercises reported as exercises per day completed over each week. Adherence defined as 80% of days with exercises completed over 12-week intervention period.
Time frame: baseline to 24-weeks
Urinary incontinence severity questionnaire, range 0-21, higher scores represent greater symptom severity, longer term outcome
Time frame: 12-weeks
Mean miles saved from home location to specialty care clinic location over 12-week intervention
VA Office of Research and Development
Fed
Optimizing Remote Access to Urinary Incontinence Treatment for Women Veterans
Acronym: PRACTICAL
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.
Published trials that share one or more normalized conditions with this study.
NCT04619238
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Lublin, Poland
View Trial DetailsNCT01599715
Behavior, Behavioral Symptoms
Ann Arbor, Michigan, United States
View Trial DetailsNCT05534412
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
La Jolla, California, United States
View Trial DetailsNCT06389838
Female Urinary Stress Incontinence, Female Urogenital Diseases
Mainz, Germany
View Trial Details