- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00492596
The AttenueX IntraVesical System for the Treatment of Female Stress Urinary Incontinence
August 7, 2014 updated by: Solace Therapeutics, Inc.
An Evaluation of the AttenueX IntraVesical System in the Management of Female Subjects With Stress Urinary Incontinence
Over 11 million women in the United States suffer from stress urinary incontinence (SUI), the involuntary leakage of urine during routine physical activities such as laughing, coughing, exercising, or sneezing.
SUI affects women of all ages and can result in significant emotional distress.
The purpose of this study is to evaluate a non-surgical, investigational treatment intended to reduce or eliminate urine leakage due to stress urinary incontinence.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A multicenter, prospective, randomized, single-blinded, two-arm longitudinal trial of the safety and effectiveness of the AttenueX Device in reducing incontinence.
Subjects randomized to the control arm will have the AttenueX Device inserted at the end of the 3-month control period.
For those subjects who are randomized to the treatment group, the AttenueX Device will be inserted into the bladder on Day 0, and replaced every 90 days by a new device for nine months.
Subjects randomized into the treatment group will be followed for a minimum of 12 months after receiving the AttenueX Device, while subjects randomized into the control group will be followed for 3 months without the AttenueX Device and a minimum of 12 months after receiving the AttenueX Device.
Study Type
Interventional
Enrollment (Actual)
166
Phase
- Phase 3
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
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Arizona
-
Tucson, Arizona, United States, 85712
- Arizona Urologic Specialists
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California
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Downey, California, United States, 90242
- Kaiser Permanente Medical Center
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Los Angeles, California, United States, 90048
- Tower Urology Institute for Incontinence
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San Diego, California, United States, 92120
- Kaiser Permanente Medical Center
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San Diego, California, United States, 92024
- Saad Juma Inc.
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Colorado
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Denver, Colorado, United States, 80220
- Genitourinary Surgical Consultants
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-
Florida
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Ft. Lauderdale, Florida, United States, 33334
- Oak Ridge Medical Plaza
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Georgia
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Atlanta, Georgia, United States, 30308
- Midtown Urology, P.C.
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-
New Jersey
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Morristown, New Jersey, United States, 07960
- Atlantic Health Systems
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New York
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Albany, New York, United States, 12205
- Northeast Urogynecology
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of Southern Carolina
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Texas
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Houston, Texas, United States, 77054
- Vanguard Urologic Institute
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Washington
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Seattle, Washington, United States, 98133
- Integrity Medical Research
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-
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
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female subjects ≥ 18 years of age
- Experienced stress urinary incontinence (SUI) for at least 12-months and failed prior non-surgical treatment
- VLPP ≥ 60cm H20
- Stamey Grade ≥ 1
- Free of local skin infection, impassable urethral strictures, trauma or necrosis
- Provide written informed consent
Exclusion Criteria:
- Pregnant or planning pregnancy
- 3 or more urinary tract infections within previous year
- Intrinsic sphincter deficiency
- Incontinence surgery within previous 6-months
- Cystocele ≥ grade 3
- Previous pelvic radiation therapy
- Presence of urethral abnormalities
- Recent urosepsis
- History of interstitial or follicular cystitis
- Uncontrolled diabetes
- Biofeedback within previous 3 months
- Morbid obesity
- Use of anticoagulants other than aspirin
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: device
insertion of balloon system
|
Insertion of the Solace AttenueX Intravesical System on Day 0
Other Names:
|
Sham Comparator: sham
cystoscopy with sham system
|
Insertion of the Solace AttenueX Intravesical System on Day 0
Other Names:
Cystoscopy with Simulated Insertion of AttenuEX Intravescial System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stamey Grade
Time Frame: 6-months
|
6-months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pad Weight
Time Frame: 6-months
|
6-months
|
VLPP
Time Frame: 6-months
|
6-months
|
I-QOL
Time Frame: 6-months
|
6-months
|
Incontinence Episode Frequency
Time Frame: 6-months
|
6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2006
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
June 25, 2007
First Submitted That Met QC Criteria
June 25, 2007
First Posted (Estimate)
June 27, 2007
Study Record Updates
Last Update Posted (Estimate)
August 11, 2014
Last Update Submitted That Met QC Criteria
August 7, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOL2004-001
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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Eli Lilly and CompanyBoehringer IngelheimCompleted
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Clinical Trials on AttenueX IntraVesical System
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Henan Cancer HospitalRecruitingIntraoperative Complications | Perfusion; Complications | High-Risk, Non-Muscle Invasive Bladder Urothelial CarcinomaChina
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Janssen Pharmaceutical K.K.RecruitingUrinary Bladder Neoplasms | Receptors, Fibroblast Growth FactorJapan
-
Janssen Research & Development, LLCRecruitingUrinary Bladder Neoplasms | Receptors, Fibroblast Growth FactorKorea, Republic of, United States, Germany, Spain, Netherlands
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Rennes University HospitalCompletedIntensive Care Unit SyndromeFrance
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National Taiwan University HospitalTerminated
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Anhembi Morumbi UniversityActive, not recruitingBladder Pain Syndrome | Interstitial Cystitis, ChronicBrazil
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The University of Western AustraliaRoyal Perth Hospital; Fiona Stanley Hospital; Perth Urology ClinicCompletedSpinal Cord InjuriesAustralia
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Loma Linda UniversityCompletedUrinary Bladder, Overactive | Urinary Incontinence, UrgeUnited States
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Michael Zell, MDNot yet recruitingOveractive Bladder | Benign Prostatic HyperplasiaUnited States
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Ankara Training and Research HospitalCompletedDisease Progression | Bladder Cancer | Recurrent Bladder Cancer