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COMPLETEDNANCT00113555

Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence

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 si...

Lead sponsor: Uromedica•5 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Uromedica

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.

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

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 French endoscope
•Neurogenic bladder
•Uncorrected rectocele, cystocele, urethrocele, enterocele or pelvic prolapse of Grade 3 or higher
•Prior pelvic radiotherapy
•Artificial urinary sphincter implanted

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 9, 2018Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment221

Start dateDec 2001

Last updatedJul 9, 2018

Condition

Urinary Incontinence

Locations shown

Kaiser Permanente

Los Angeles, California

Emory University School of Medicine

Atlanta, Georgia

Lahey Clinic

Burlington, Massachusetts

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2018Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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