Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence
ACT
Clinical Investigation of an Adjustable Continence Therapy (ACT) Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility
1 other identifier
interventional
221
2 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2001
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
June 8, 2005
CompletedFirst Posted
Study publicly available on registry
June 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
June 4, 2018
CompletedJuly 9, 2018
July 1, 2018
6.6 years
June 8, 2005
January 4, 2016
July 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline to 12 months
Secondary Outcomes (6)
Incontinence Quality of Life (IQoL) Questionnaire
Baseline to 12 months
Incontinence Impact Questionnaire (IIQ-7)
Baseline to 12 months
Urinary Distress Inventory (UDI-6)
Baseline to 12 months
Number of Incontinence Episodes Per Day (Voiding Diary)
Baseline to 12 months
Number of Pads Changed Per Day (Voiding Diary)
Baseline to 12 months
- +1 more secondary outcomes
Study Arms (1)
Experimental
EXPERIMENTALOpen Label Study, ACT (Adjustable Continence Therapy)
Interventions
Eligibility Criteria
You may qualify if:
- Women
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uromedicalead
Study Sites (7)
Kaiser Permanente
Los Angeles, California, 90027, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Metro Urology
Plymouth, Minnesota, 55441, United States
Kansas City Urology Care
Kansas City, Missouri, 64123, United States
Can-Med Clinical Research Inc.
Victoria, British Columbia, V8T5GI, Canada
CHUS-Fleurimont
Fleurimont, Quebec, J1H5N4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Timothy Plouffe
- Organization
- Uromedica
Study Officials
- STUDY DIRECTOR
Tim Cook
Uromedica, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2005
First Posted
June 9, 2005
Study Start
December 1, 2001
Primary Completion
July 1, 2008
Study Completion
November 1, 2010
Last Updated
July 9, 2018
Results First Posted
June 4, 2018
Record last verified: 2018-07