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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00113555
Recruitment Status : Completed
First Posted : June 9, 2005
Last Update Posted : June 13, 2011
Information provided by:

Brief Summary:

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 or disease Intervention/treatment Phase
Urinary Incontinence Device: ACT (Adjustable Continence Therapy) Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2001
Primary Completion Date : July 2008
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental
Open Label Study
Device: ACT (Adjustable Continence Therapy)
surgically implanted device

Primary Outcome Measures :
  1. Pad weight [ Time Frame: 2009 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113555

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
Fleurimont, Quebec, Canada, J1H5N4
Sponsors and Collaborators
Study Director: Tim Cook Uromedica, Inc.

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
First Posted: June 9, 2005    Key Record Dates
Last Update Posted: June 13, 2011
Last Verified: May 2011

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
Behavioral Symptoms
Elimination Disorders
Mental Disorders