Reviewed by Michael Gill, B. Sc.
Image of Magee Women's Hospital of UPMC in Pittsburgh, United States.
Phase-Based Progress Estimates
1
Effectiveness
1
Safety

Disposable Urethral Support Devicefor Urinary Incontinence

18+
Female
Evaluate the feasibility of a randomized controlled trial of non-surgical urinary incontinence (UI) management options for women with CF. The investigators will complete a pilot, feasibility study (n=30) to compare tolerability and symptom relief in women with CF and UI. Subjects will be recruited from the University of Pittsburgh Cystic Fibrosis Center after demonstrating bother from UI on initial phone script. Participants will undergo UI questionnaires and undergo a pelvic examination, non-invasive bladder scan ultrasound and a provocative stress test and then be randomized to either a disposable urethral support device (Impressa®), an absorbent product (Speax Reusable Underwear), or Pelvic floor muscle therapy. The primary outcome will be to determine the feasibility and tolerability of these options. Hypothesis: All three non-surgical UI management options for women are feasible (as measured by 80% adherence to treatment assignment over 7 days) and tolerable (as measured by patient report via questionnaire). The results from the proposed aims will provide important information about the experiences and symptom burden of women with CF and UI. Importantly, the investigators will also be able to answer the important questions of "Can it work?" and "Does it work?" as the investigators seek to construct the definitive, adequately powered trial of these therapies in women with CF and UI.
Recruiting
Has No Placebo
Magee Women's Hospital of UPMCMegan Bradley, MD
25 Urinary Incontinence Clinical Trials Near Me
Top Hospitals for Urinary Incontinence Clinical Trials
Image of University of Pittsburgh in Pennsylvania.
University of Pittsburgh
Pittsburgh
3Active Trials
13All Time Trials for Urinary Incontinence
2002First Urinary Incontinence Trial
Image of University of Iowa in Iowa.
University of Iowa
Iowa City
2Active Trials
4All Time Trials for Urinary Incontinence
2004First Urinary Incontinence Trial
Top Cities for Urinary Incontinence Clinical Trials
Image of Winston-Salem in North Carolina.
Winston-Salem
5Active Trials
Wake Forest Baptist Medical CenterTop Active Site
Urinary Incontinence Clinical Trials by Phase of Trial
Phase < 1 Urinary Incontinence Clinical Trials
2Active Urinary Incontinence Clinical Trials
2Number of Unique Treatments
1Number of Active Locations
Estradiol vaginal creamonabotulinumtoxin A
Urinary Incontinence Clinical Trials by Age Group
< 18 Urinary Incontinence Clinical Trials
1Active Urinary Incontinence Clinical Trials
Manual Trigger
Most Recent Urinary Incontinence Clinical Trials
Top Treatments for Urinary Incontinence Clinical Trials
Treatment Name
Active Urinary Incontinence Clinical Trials
All Time Trials for Urinary Incontinence
First Recorded Urinary Incontinence Trial
Yoga Practice Program
2
2
2018
Arm 1
1
1
2022
Adjustable Transobturator Male System
1
1
2022
Platelet-rich plasma injection
1
1
2022
Anticholinergic bladder medication
1
1
2022
Recently Completed Studies with FDA Approved Treatments for Urinary Incontinence
Treatment
Year
Sponsor
Gefapixant
2020
Merck Sharp & Dohme Corp.

What Are Urinary Incontinence Clinical Trials?

Clinical trials, and all other types of clinical studies, are necessary for medical research. They help researchers and healthcare professionals learn more about diseases and improve their ability to care for people in the future. Urinary incontinence clinical trials involve researchers studying several aspects of bladder control problems to determine how to control, treat, and resolve bladder function issues.

Why Is Urinary Incontinence Being Studied Through Clinical Trials?

Urinary incontinence is a significant issue affecting approximately 200 million people worldwide. There are several types of urinary incontinence issues, the most prevalent being stress urinary incontinence, affecting an estimated 15 million adult women in the US. Approximately 17% of adult women and 16% of adult men suffer from another type of urinary incontinence issue called overactive bladder. An estimated 12.2 million adults suffer from urge incontinence. Studying the prevalent health issue through clinical trials can improve how healthcare providers can better treat the issue.

What Are The Types of Treatments Available For Urinary Incontinence?

Treatments for urinary incontinence depend on the type, severity, and root cause of the problem. The need for a combination of treatments might be necessary. If there is an underlying source of the problem, your doctor may first focus on treating that. Some of the treatments available for urinary incontinence include:

  • Behavioral techniques to treat urinary incontinence involve bladder training when you feel the urge to go, double voiding, scheduling toilet trips instead of waiting for the urge to go, and diet and fluid intake management.
  • The doctor may recommend several pelvic floor muscle exercises for females with the condition. Also called Kegel exercises, these techniques strengthen the muscles responsible for controlling urination.
  • Drug interventions for treating urinary incontinence may involve drugs like anticholinergics, alpha-blockers, mirabegron, and topical estrogen.
  • Electrical stimulation through electrodes providing gentle electric stimulation is another possible treatment.
  • Medical devices like catheters, pessaries, and urethral inserts can also be used to treat people with incontinence issues.
  • Extreme cases may warrant surgeries specific to the type and severity of urinary incontinence.

What Are Some Recent Breakthrough Clinical Trials For Urinary Incontinence?

Clinical trials on urinary incontinence primarily focus on treating the condition and helping healthcare professionals improve their approach through more effective interventions. There have been several breakthroughs

2017: The Urinary Incontinence Treatment Study (UNITS) - A clinical trial that observed 71 participants conducted a study on the role of sarcopenia and functional impairment in how healthcare professionals manage urinary incontinence in older women. Participants with impaired physical function had higher BMI and more baseline urinary incontinence episodes than participants with normal physical function. The study suggested that pelvic floor muscle training might not significantly improve urinary incontinence symptoms in women older than 70.

2021: Management of Urinary Incontinence Following Treatment of Prostate Disease - The clinical trial observed men undergoing prostate disease treatment because they are at higher risk of developing urinary incontinence. Men suffering from incontinence after prostate treatment (IPT) were provided with several treatments. The clinical trial concluded that professionals treating men suffering from IPT must determine the exact nature of UI symptoms to form better treatment and management courses.

Who Are Some of The Key Opinion Leaders / Researchers / Institutions Conducting Urinary Incontinence Clinical Trials?

Michael B Chancellor, MD, is a urologist in Royal Oak, Michigan, and has gained national and international recognition in the medical field as a world-renowned author and speaker. He has written over 550 peer-reviewed articles and book chapters in important journals and serves on the editorial board of 12 scientific journals.

The Dartmouth Hitchcock Medical Center is the flagship academic medical center of Dartmouth Health, New Hampshire, and it has recently been approved for a $6.6 million funding award to identify and study nonsurgical treatments for urinary incontinence by the Patient-Centered Outcomes Research Institute.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: October 6th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

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