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

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ClinicalTrials.gov Identifier: NCT00113555
Recruitment Status : Completed
First Posted : June 9, 2005
Results First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Uromedica

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) Not Applicable

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
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
Actual Primary Completion Date : July 2008
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change of Stamey Grade From Baseline to 12 Months. [ Time Frame: 12 months ]

    The Stamey grade classifies the severity of stress incontinence in four possible grades from 0-3. Grade 0: no leaking, Grade 1: loss of urine with sudden increases of abdominal pressure: e.g. coughing, sneezing or laughing, Grade 2: loss of urine with lesser degrees of stress: e.g. walking or standing up, and Grade 3: loss of urine without any relation to physical activity or position, e.g. while lying in bed.

    The primary end point at 12 months is a mean change in Stamey Grade from baseline of greater than or equal to -1.



Secondary Outcome Measures :
  1. Incontinence Quality of Life (IQoL) Questionnaire [ Time Frame: 12 months ]
    Change on Incontinence Quality of Life (IQoL) Questionnaire from baseline to 12 months. 0 being lowest quality of life, 100 being highest quality of life.

  2. Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: 12 months ]
    Incontinence Impact Questionnaire (IIQ-7) change from baseline to 12 months. Scores range from 0-100. 0 being impact from incontinence, 100 being most impacted from incontinence.

  3. Urinary Distress Inventory (UDI-6) [ Time Frame: 12 months ]
    Change on Urinary Distress Inventory (UDI-6) questionnaire from baseline to 12 months. 0 being not distressed, 100 being very distressed.

  4. Number of Incontinence Episodes Per Day (Voiding Diary) [ Time Frame: 12 months ]
    Change in Number of Incontinence Episodes Per Day from baseline to 12 months. 0 being the best.

  5. Number of Pads Changed Per Day (Voiding Diary) [ Time Frame: 12 months ]
    Change in Number of Pads Changed Per Day from baseline to 12 months. 0 pads changed a day being the best.

  6. Provocative Pad Weight [ Time Frame: 12 months ]
    Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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 French 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


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.

Responsible Party: Uromedica
ClinicalTrials.gov Identifier: NCT00113555     History of Changes
Other Study ID Numbers: URM01-01-01
First Posted: June 9, 2005    Key Record Dates
Results First Posted: June 4, 2018
Last Update Posted: June 4, 2018
Last Verified: April 2018

Keywords provided by Uromedica:
urinary incontinence

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