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

July 5, 2018 updated by: Uromedica

Clinical Investigation of an Adjustable Continence Therapy (ACT) Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8T5GI
        • Can-Med Clinical Research Inc.
    • Quebec
      • Fleurimont, Quebec, Canada, J1H5N4
        • CHUS-Fleurimont
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • Minnesota
      • Plymouth, Minnesota, United States, 55441
        • Metro Urology
    • Missouri
      • Kansas City, Missouri, United States, 64123
        • Kansas City Urology Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental
Open Label Study, ACT (Adjustable Continence Therapy)
Device: ACT (Adjustable Continence Therapy)
surgically implanted device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Stamey Grade From Baseline to 12 Months.
Time Frame: Baseline to 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.
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incontinence Quality of Life (IQoL) Questionnaire
Time Frame: Baseline to 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.
Baseline to 12 months
Incontinence Impact Questionnaire (IIQ-7)
Time Frame: Baseline to 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.
Baseline to 12 months
Urinary Distress Inventory (UDI-6)
Time Frame: Baseline to 12 months
Change on Urinary Distress Inventory (UDI-6) questionnaire from baseline to 12 months. 0 being not distressed, 100 being very distressed.
Baseline to 12 months
Number of Incontinence Episodes Per Day (Voiding Diary)
Time Frame: Baseline to 12 months
Change in Number of Incontinence Episodes Per Day from baseline to 12 months. 0 being the best.
Baseline to 12 months
Number of Pads Changed Per Day (Voiding Diary)
Time Frame: Baseline to 12 months
Change in Number of Pads Changed Per Day from baseline to 12 months. 0 pads changed a day being the best.
Baseline to 12 months
Provocative Pad Weight
Time Frame: Baseline to 12 months
Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uromedica

Investigators

  • Study Director: Tim Cook, Uromedica, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

June 8, 2005

First Submitted That Met QC Criteria

June 8, 2005

First Posted (ESTIMATE)

June 9, 2005

Study Record Updates

Last Update Posted (ACTUAL)

July 9, 2018

Last Update Submitted That Met QC Criteria

July 5, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URM01-01-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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