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Changes in ALPP in Women With SUI Following Air Instillation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Meir Medical Center
Sponsor:
Collaborator:
The Trendlines Group
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT02113670
First received: March 28, 2014
Last updated: March 15, 2016
Last verified: March 2016
History of Changes
  Purpose

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 Intervention Phase
Stress Urinary Incontinence
 Other: SUI 1
 Phase 1
Phase 2

Study Type: Interventional
Study Design: 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 Air Instillation During Urodynamic Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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 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 [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 10
Study Start Date: March 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 50ml of air instillation into the bladder

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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02113670

Contacts
Contact: Michael Vainrib, M.D. 972584705941 mvainrib@gmail.com

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel, 44410
Contact: Michael Vainrib, M.D.    972584705941    mvainrib@gmail.com   
Principal Investigator: Michael Vainrib, M.D.         
Sponsors and Collaborators
Meir Medical Center
The Trendlines Group
  More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT02113670     History of Changes
Other Study ID Numbers: TrendLinesSUI 
Study First Received: March 28, 2014
Last Updated: March 15, 2016
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
stress urinary incontinence
abdominal leak point pressure
urodynamic study

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
 Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 23, 2016