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

This study has been completed.

Sponsor:

Information provided by:

Uromedica

ClinicalTrials.gov Identifier:

NCT00113555

First received: June 8, 2005

Last updated: June 10, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 8, 2005

Last Updated Date

June 10, 2011

Start Date ^ICMJE

December 2001

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pad weight [ Time Frame: 2009 ] [ Designated as safety issue: No ]

If pad weight test done for 24hr period over 18month,demonstrates a reduction of 50% or more the result is considered a success of the device.

Original Primary Outcome Measures ^ICMJE

Efficacy: Determine whether use of the ACT device results in a mean reduction from baseline in Stamey score of greater than or equal to one grade at twelve months post implant.
Safety: Characterize the frequency of complications that occur among subjects implanted with the ACT system at the time of the procedure and continuing through the 12-month follow-up.

Change History

Complete list of historical versions of study NCT00113555 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Assess the clinical utility of the ACT device in improving patient's quality of life.
Characterize the safety of the ACT device by quantifying the risk of anticipated and unanticipated adverse events.
Evaluate the technical feasibility of the delivery system to position the prosthetic at the bladder neck.
To assess the ability to adjust the amount of urethral coaptation and bladder neck support post-operatively.

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Clinical Investigation of an Adjustable Continence Therapy (ACT) Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Urinary Incontinence

Intervention ^ICMJE

Device: ACT (Adjustable Continence Therapy)

surgically implanted device

Study Arm (s)

Experimental: Experimental

Open Label Study

Intervention: Device: ACT (Adjustable Continence Therapy)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

221

Completion Date

November 2010

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00113555

Other Study ID Numbers ^ICMJE

URM01-01-01

Has Data Monitoring Committee

Responsible Party

Sabitha R Shriram ,Sr.Clinical Research Specialist, Uromedica Inc.

Study Sponsor ^ICMJE

Uromedica

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Tim Cook

Uromedica, Inc.

Information Provided By

Uromedica

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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