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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Incontinence, Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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device

insertion of balloon system

Group Type EXPERIMENTAL

AttenueX IntraVesical System

Intervention Type DEVICE

Insertion of the Solace AttenueX Intravesical System on Day 0

sham

cystoscopy with sham system

Group Type SHAM_COMPARATOR

AttenueX IntraVesical System

Intervention Type DEVICE

Insertion of the Solace AttenueX Intravesical System on Day 0

Sham Procedure

Intervention Type PROCEDURE

Cystoscopy with Simulated Insertion of AttenuEX Intravescial System

Interventions

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AttenueX IntraVesical System

Insertion of the Solace AttenueX Intravesical System on Day 0

Intervention Type DEVICE

Sham Procedure

Cystoscopy with Simulated Insertion of AttenuEX Intravescial System

Intervention Type PROCEDURE

Other Intervention Names

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Solace Balloon

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No