Clinical trial NCT00113555: Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence
Official title: Clinical Investigation of an Adjustable Continence Therapy (ACT) Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence
Lead sponsor: Uromedica
Sponsor class: INDUSTRY
First posted: 2005-06-09
Enrollment: 221
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Change of Stamey Grade From Baseline to 12 Months.
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Incontinence Quality of Life (IQoL) Questionnaire
timeFrame: Baseline to 12 months
measure: Incontinence Impact Questionnaire (IIQ-7)
timeFrame: Baseline to 12 months
measure: Urinary Distress Inventory (UDI-6)
timeFrame: Baseline to 12 months
measure: Number of Incontinence Episodes Per Day (Voiding Diary)
timeFrame: Baseline to 12 months
measure: Number of Pads Changed Per Day (Voiding Diary)
timeFrame: Baseline to 12 months
measure: Provocative Pad Weight
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Plymouth
country: United States
facility: Metro Urology
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Urology Care
state: Missouri
city: Victoria
country: Canada
facility: Can-Med Clinical Research Inc.
state: British Columbia
city: Fleurimont
country: Canada
facility: CHUS-Fleurimont
state: Quebec
Study officials:
affiliation: Uromedica, Inc.
name: Tim Cook
role: STUDY_DIRECTOR
References: