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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ACT (Adjustable Continence Therapy)
Sponsored by
Uromedica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kaiser Permanente
  • Emory University School of Medicine
  • Lahey Clinic
  • Metro Urology
  • Kansas City Urology Care
  • Can-Med Clinical Research Inc.
  • CHUS-Fleurimont

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Open Label Study, ACT (Adjustable Continence Therapy)

Outcomes

Primary Outcome Measures

Change of Stamey Grade From 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.

Secondary Outcome Measures

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

Full Information

First Posted
June 8, 2005
Last Updated
July 5, 2018
Sponsor
Uromedica
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1. Study Identification

Unique Protocol Identification Number
NCT00113555
Brief Title
Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence
Acronym
ACT
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 Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uromedica

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Open Label Study, ACT (Adjustable Continence Therapy)
Intervention Type
Device
Intervention Name(s)
ACT (Adjustable Continence Therapy)
Intervention Description
surgically implanted device
Primary Outcome Measure Information:
Title
Change of Stamey Grade From Baseline to 12 Months.
Description
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.
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Incontinence Quality of Life (IQoL) Questionnaire
Description
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.
Time Frame
Baseline to 12 months
Title
Incontinence Impact Questionnaire (IIQ-7)
Description
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.
Time Frame
Baseline to 12 months
Title
Urinary Distress Inventory (UDI-6)
Description
Change on Urinary Distress Inventory (UDI-6) questionnaire from baseline to 12 months. 0 being not distressed, 100 being very distressed.
Time Frame
Baseline to 12 months
Title
Number of Incontinence Episodes Per Day (Voiding Diary)
Description
Change in Number of Incontinence Episodes Per Day from baseline to 12 months. 0 being the best.
Time Frame
Baseline to 12 months
Title
Number of Pads Changed Per Day (Voiding Diary)
Description
Change in Number of Pads Changed Per Day from baseline to 12 months. 0 pads changed a day being the best.
Time Frame
Baseline to 12 months
Title
Provocative Pad Weight
Description
Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best.
Time Frame
Baseline to 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Cook
Organizational Affiliation
Uromedica, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Metro Urology
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Kansas City Urology Care
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64123
Country
United States
Facility Name
Can-Med Clinical Research Inc.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T5GI
Country
Canada
Facility Name
CHUS-Fleurimont
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada

12. IPD Sharing Statement

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

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