The AttenueX IntraVesical System for the Treatment of Female Stress Urinary Incontinence

Urinary Incontinence, Stress Clinical Trial

Official title:

An Evaluation of the AttenueX IntraVesical System in the Management of Female Subjects With Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492596
• Other study ID #: SOL2004-001
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2007
• Last updated: August 7, 2014
• Start date: June 2006
• Est. completion date: June 2011

Study information

• Verified date: August 2014
• Source: Solace Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Over 11 million women in the United States suffer from stress urinary incontinence (SUI), the involuntary leakage of urine during routine physical activities such as laughing, coughing, exercising, or sneezing. SUI affects women of all ages and can result in significant emotional distress. The purpose of this study is to evaluate a non-surgical, investigational treatment intended to reduce or eliminate urine leakage due to stress urinary incontinence.

Description:

A multicenter, prospective, randomized, single-blinded, two-arm longitudinal trial of the safety and effectiveness of the AttenueX Device in reducing incontinence. Subjects randomized to the control arm will have the AttenueX Device inserted at the end of the 3-month control period. For those subjects who are randomized to the treatment group, the AttenueX Device will be inserted into the bladder on Day 0, and replaced every 90 days by a new device for nine months. Subjects randomized into the treatment group will be followed for a minimum of 12 months after receiving the AttenueX Device, while subjects randomized into the control group will be followed for 3 months without the AttenueX Device and a minimum of 12 months after receiving the AttenueX Device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female subjects = 18 years of age

• Experienced stress urinary incontinence (SUI) for at least 12-months and failed prior non-surgical treatment

• VLPP = 60cm H20

• Stamey Grade = 1

• Free of local skin infection, impassable urethral strictures, trauma or necrosis

• Provide written informed consent

Exclusion Criteria:

• Pregnant or planning pregnancy

• 3 or more urinary tract infections within previous year

• Intrinsic sphincter deficiency

• Incontinence surgery within previous 6-months

• Cystocele = grade 3

• Previous pelvic radiation therapy

• Presence of urethral abnormalities

• Recent urosepsis

• History of interstitial or follicular cystitis

• Uncontrolled diabetes

• Biofeedback within previous 3 months

• Morbid obesity

• Use of anticoagulants other than aspirin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• AttenueX IntraVesical System
Insertion of the Solace AttenueX Intravesical System on Day 0

Procedure:
• Sham Procedure
Cystoscopy with Simulated Insertion of AttenuEX Intravescial System

Locations

Country	Name	City	State
United States	Northeast Urogynecology	Albany	New York
United States	Midtown Urology, P.C.	Atlanta	Georgia
United States	Medical University of Southern Carolina	Charleston	South Carolina
United States	Genitourinary Surgical Consultants	Denver	Colorado
United States	Kaiser Permanente Medical Center	Downey	California
United States	Oak Ridge Medical Plaza	Ft. Lauderdale	Florida
United States	Vanguard Urologic Institute	Houston	Texas
United States	Tower Urology Institute for Incontinence	Los Angeles	California
United States	Atlantic Health Systems	Morristown	New Jersey
United States	Kaiser Permanente Medical Center	San Diego	California
United States	Saad Juma Inc.	San Diego	California
United States	Integrity Medical Research	Seattle	Washington
United States	Arizona Urologic Specialists	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Solace Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stamey Grade		6-months	No
Secondary	Pad Weight		6-months	No
Secondary	VLPP		6-months	No
Secondary	I-QOL		6-months	No
Secondary	Incontinence Episode Frequency		6-months	No