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

Uromedica

Status: Completed

Conditions: Urinary Incontinence

Treatments: Device: ACT (Adjustable Continence Therapy)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00113555

URM01-01-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 221 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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221 participants in 1 patient group

Experimental

Experimental group

Description:

Open Label Study, ACT (Adjustable Continence Therapy)

Treatment:

Device: ACT (Adjustable Continence Therapy)