Changes in ALPP in Women With SUI Following Air Instillation

NCT02113670 | Completed

• 1 other identifier: TrendLinesSUI
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence; abdominal leak point pressure; urodynamic study

Outcome Measures

Primary Outcomes (1)

• change in abdominal leak point pressure

  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.

  1 day

Secondary Outcomes (1)

• adverse events as a measure of safety and tolerability

  1 week

Study Arms (1)

SUI 1

EXPERIMENTAL

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

Other: SUI 1

Interventions

SUI 1 OTHER

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

Also known as: 50ml of air instillation into the bladder

SUI 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meir Medical Center: lead
• The Trendlines Group: collaborator

Study Sites (1)

Meir Medical Center

Kfar Saba, 44410, Israel

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 14, 2014
• Study Start: March 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

IL (1)