Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence

This study has been completed.
Sponsor:
Information provided by:
Uromedica
ClinicalTrials.gov Identifier:
NCT00113555
First received: June 8, 2005
Last updated: June 10, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.

The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether the patients demonstrate at least a one-grade (mean) reduction in the Stamey score at 12 months.


Condition Intervention Phase
Urinary Incontinence
Device: ACT (Adjustable Continence Therapy)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Investigation of an Adjustable Continence Therapy (ACT) Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility

Resource links provided by NLM:


Further study details as provided by Uromedica:

Primary Outcome Measures:
  • Pad weight [ Time Frame: 2009 ] [ Designated as safety issue: No ]
    If pad weight test done for 24hr period over 18month,demonstrates a reduction of 50% or more the result is considered a success of the device.


Enrollment: 221
Study Start Date: December 2001
Study Completion Date: November 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Open Label Study
Device: ACT (Adjustable Continence Therapy)
surgically implanted device

Detailed Description:

This is a multi-center, prospective, non randomized clinical trial comparing baseline data to the 12 month data. Urodynamic testing, pad weights and a direct visual stress test will be used to determine success along with the Stamey score.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women
  • 18 years or older
  • Diagnosed with stress urinary incontinence with or without urethral hypermobility
  • Willing to sign informed consent
  • Candidates for surgical intervention for stress incontinence
  • Negative urinalysis or urine culture within 2 weeks of implantation
  • Normal cystourethroscopy
  • Failed at least 6 months of previous treatments for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc.)
  • May have failed suspension or sling procedures

Exclusion Criteria:

  • Pregnant or lactating
  • Life expectancy of less than one year
  • Insulin dependant diabetic
  • Auto-immune disease
  • Undergoing radiation therapy
  • Active urinary tract infection
  • Detrusor instability refractory to meds
  • Reduced bladder compliance
  • Significant bladder residual >100mls
  • Bladder cancer
  • Unsuccessfully treated bladder stones
  • Current urethral stricture preventing the passage of a 24 FR endoscope
  • Neurogenic bladder
  • Uncorrected rectocele, cystocele, urethrocele, enterocele or pelvic prolapse of Grade 3 or higher
  • Prior pelvic radiotherapy
  • Artificial urinary sphincter implanted
  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: NCT00113555

Locations
United States, California
Kaiser Permanente
Los Angeles, California, United States, 90027
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Minnesota
Metro Urology
Plymouth, Minnesota, United States, 55441
United States, Missouri
Kansas City Urology Care
Kansas City, Missouri, United States, 64123
Canada, British Columbia
Can-Med Clinical Research Inc.
Victoria, British Columbia, Canada, V8T5GI
Canada, Quebec
CHUS-Fleurimont
Fleurimont, Quebec, Canada, J1H5N4
Sponsors and Collaborators
Uromedica
Investigators
Study Director: Tim Cook Uromedica, Inc.
  More Information

No publications provided

Responsible Party: Sabitha R Shriram ,Sr.Clinical Research Specialist, Uromedica Inc.
ClinicalTrials.gov Identifier: NCT00113555     History of Changes
Other Study ID Numbers: URM01-01-01
Study First Received: June 8, 2005
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Uromedica:
urinary incontinence

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

ClinicalTrials.gov processed this record on September 18, 2014