Clinical trial NCT02113670: Changes in ALPP in Women With SUI Following Air Instillation
Official title: Changes in Abdominal Leak Point Pressures in Women Stress Urinary Incontinence Following Intravesical Air Instillation During Urodynamic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
abdominal leak point pressure
urodynamic study
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: The Trendlines Group
First posted: 2014-04-14
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in abdominal leak point pressure
timeFrame: 1 day
Secondary outcomes:
measure: adverse events as a measure of safety and tolerability
timeFrame: 1 week
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References: