Changes in ALPP in Women With SUI Following Air Instillation

Sponsor

Meir Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02113670

Collaborator

The Trendlines Group (Other)

Enrollment

Location

Arm

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 air into the urinary bladder, which eliminates or greatly reduces involuntary urinary leakage. The air 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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Other: SUI 1	N/A

Detailed Description

Following positive results of this proof of concept study we could plan further innovative device to treat SUI in women.

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Changes in Abdominal Leak Point Pressures in Women Stress Urinary Incontinence Following Intravesical Air Instillation During Urodynamic Study

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Dec 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SUI 1 Patients will perform urodynamic study before and after instillation of 50 ml of air	Other: SUI 1 instillation of 50ml of air into the urinary bladder before the urodynamic test Other Names: 50ml of air instillation into the bladder

Arm

Intervention/Treatment

Experimental: SUI 1

Patients will perform urodynamic study before and after instillation of 50 ml of air

Other: SUI 1

instillation of 50ml of air into the urinary bladder before the urodynamic test

Other Names:

50ml of air instillation into the bladder

Outcome Measures

Primary Outcome Measures

change in abdominal leak point pressure [1 day]
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 50 ml of air into the bladder during the urodynamic study in patients with SUI.

Secondary Outcome Measures

adverse events as a measure of safety and tolerability [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women
Age >18 years old
SUI: pure or stress predominant mixed urinary incontinence.
Failure of conservative treatment who desires surgical procedure for SUI.
Signed informed consent for the trial and urodynamic study.
Negative urine culture.

Exclusion Criteria:

Neurogenic SUI
Unable or unwilling to sign informed consent for the trial and urodynamic study.
Patient who does not will a surgery for SUI
Prior pelvic or lower abdominal malignancies
Prior pelvic radiation or surgery except anterior/posterior colporrhaphy or hysterectomy (with or without oophorectomy) for benign disease.