Changes in Abdominal Leak Point Pressures in Women Stress Urinary Incontinence Following Intravesical Gas (CO2 or Air) Instillation During Urodynamic Study
More than 11 million women in the United States suffer from stress urinary incontinence (SUI), the involuntary leakage of urine during everyday activities that put temporary stress on the abdomen and bladder, such as laughing, coughing, and walking. For women with SUI, this pressure often causes urine to leak involuntarily. SUI affects women of all ages including young mothers, pre-menopausal women, and seniors, and can result in significant emotional distress. Current solutions for SUI include disposable pads, behavioral treatment (pelvic floor physical therapy) and surgical intervention. Patients with SUI who failed conservative treatment and wish to be further treated by a surgery may require further work-up by urodynamic study in which abdominal leak point pressures (ALPP) defined and reflect the severity of SUI.
There is continuous need to develop less invasive treatments for SUI that could minimize the use of pads, could be an alternative to painful, costly surgical procedure. The Trendlines Group lab solution is a non-surgical alternative in the treatment of SUI. The concept of the future treatment solution is based on simple physics: injecting a small amount of gas (CO2 or air) into the urinary bladder, which eliminates or greatly reduces involuntary urinary leakage. The gas bubble acts as a "shock absorber" to reduce the temporary pressure increase in the bladder that causes urinary leakage. The concept for the new treatment has been tested in a lab environment using lab jig tests and pig urinary system (bladder and urethra). The lab tests showed significant improvement in the bladder pressure when the treatment was implemented by suspending the stress pressure to a level that will not cause urine leakage.
Stress Urinary Incontinence
Other: gas (CO2 or air) instillation into the bladder
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Changes in Abdominal Leak Point Pressures in Women Stress Urinary Incontinence Following Intravesical Gas (CO2 or Air) Instillation During Urodynamic Study|
- change in abdominal leak point pressure [ Time Frame: 1 day ] [ Designated as safety issue: No ]to verify the concept of a possible future treatment in the clinical setup by checking physical effect of dumping pressure (decrease in ALLP) by inserting 30 or 50 ml of gas (air or CO2) into the bladder during the urodynamic study in patients with SUI.
- adverse events as a measure of safety and tolerability [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: SUI 1||Other: gas (CO2 or air) instillation into the bladder|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02113670
|Contact: Michael Vainrib, M.D.||firstname.lastname@example.org|
|Meir Medical Center||Not yet recruiting|
|Kfar Saba, Israel, 44410|
|Contact: Michael Vainrib, M.D. 972584705941 email@example.com|
|Principal Investigator: Michael Vainrib, M.D.|