Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2012-09-30
2017-01-31
Brief Summary
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Detailed Description
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All patients undergoing sham treatment are treated at 3 months.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Treatment on Day 0
Subjects who are treated with the Solace Bladder Control System upon entry into the trial.
Solace Bladder Control System
Subjects may undergo treatment every 12 months until study completion.
Sham Treatment on Day 0
Patients who undergo a sham procedure upon entry into the trial, with treatment with the Solace Bladder Control System at 3 months after the sham procedure.
Solace Bladder Control System
Subjects may undergo treatment every 12 months until study completion.
Solace Sham Treatment
Sham procedure that resembles treatment with the Solace Bladder Control System
Interventions
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Solace Bladder Control System
Subjects may undergo treatment every 12 months until study completion.
Solace Sham Treatment
Sham procedure that resembles treatment with the Solace Bladder Control System
Eligibility Criteria
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Inclusion Criteria
* Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment
* Willing to undergo cystoscopic procedures required and 36 month follow-up
* On stable medication for a minimum of 3 months
* Free of local genital skin infection
* Positive Pad Weight Test
* Free of impassable urethral strictures, trauma or necrosis
Exclusion Criteria
* Non-ambulatory or bedridden or physically unable to complete test exercises
* Morbidly obese (defined as BMI ≥ 40 kg/m2)
* Bladder infection (including bladder inflammation or edema) or UTI within 3 months
* History of recurrent urinary tract infections
* Prior surgical procedure for incontinence within the past 6 months
* Is taking medications for urinary incontinence other than anticholinergics
* History of kidney stones
* Has a prosthetic heart valve
* Unable to tolerate any form of antibiotic
* Taking anticoagulation therapy, other than aspirin
* Has urinary incontinence due to Intrinsic Sphincter Deficiency (ISD)
18 Years
FEMALE
No
Sponsors
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Solace Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Giovanni Tommaselli, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Naples
Locations
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University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen)
Antwerp, Edegem, Belgium
UZ Brussel
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
University of Naples (Università Degli Studi Di Napoli "Federico II" )
Naples (Napoli), , Italy
Universita Campus Bio-medico di Roma
Rome, , Italy
Catharina Ziekenhuis
Eindhoven, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Countries
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References
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Wyndaele JJ, De Wachter S, Tommaselli GA, Angioli R, de Wildt MJ, Everaert KC, Michielsen DP, Van Koeveringe GA. A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females. Neurourol Urodyn. 2016 Feb;35(2):252-9. doi: 10.1002/nau.22708. Epub 2015 Jan 16.
Other Identifiers
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CD 1004
Identifier Type: -
Identifier Source: org_study_id
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