Changes in ALPP in Women With SUI Following Air Instillation

Clalit Health Services

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Other: SUI 1

Study type: Interventional

Funder types: Other

Identifiers

NCT02113670

TrendLinesSUI

Details and patient eligibility

About

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.

Full description

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.

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

Enrollment: 8 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

SUI 1

Experimental group

Description:

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

Treatment:

Other: SUI 1