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
Results First Posted : June 4, 2018
Last Update Posted : July 9, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||221 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Open Label Study, ACT (Adjustable Continence Therapy)
Device: ACT (Adjustable Continence Therapy)
surgically implanted device
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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|
|Los Angeles, California, United States, 90027|
|United States, Georgia|
|Emory University School of Medicine|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Burlington, Massachusetts, United States, 01805|
|United States, Minnesota|
|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|
|Fleurimont, Quebec, Canada, J1H5N4|
|Study Director:||Tim Cook||Uromedica, Inc.|