Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence
This study has been completed.
Sponsor:
Uromedica
Information provided by:
Uromedica
ClinicalTrials.gov Identifier:
NCT00113555
First received: June 8, 2005
Last updated: June 10, 2011
Last verified: May 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Urinary Incontinence |
Device: ACT (Adjustable Continence Therapy) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Uromedica:
Primary Outcome Measures:
- Pad weight [ Time Frame: 2009 ] [ Designated as safety issue: No ]If pad weight test done for 24hr period over 18month,demonstrates a reduction of 50% or more the result is considered a success of the device.
| Enrollment: | 221 |
| Study Start Date: | December 2001 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental
Open Label Study
|
Device: ACT (Adjustable Continence Therapy)
surgically implanted device
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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 FR endoscope
- Neurogenic bladder
- Uncorrected rectocele, cystocele, urethrocele, enterocele or pelvic prolapse of Grade 3 or higher
- Prior pelvic radiotherapy
- Artificial urinary sphincter implanted
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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. |
More Information
No publications provided
| Responsible Party: | Sabitha R Shriram ,Sr.Clinical Research Specialist, Uromedica Inc. |
| ClinicalTrials.gov Identifier: | NCT00113555 History of Changes |
| Other Study ID Numbers: | URM01-01-01 |
| Study First Received: | June 8, 2005 |
| Last Updated: | June 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Uromedica:
|
urinary incontinence |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013