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

Primary Purpose

Urinary Incontinence, Stress

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AttenueX IntraVesical System
Sham Procedure
Sponsored by
Solace Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Urologic Specialists
  • Kaiser Permanente Medical Center
  • Tower Urology Institute for Incontinence
  • Saad Juma Inc.
  • Kaiser Permanente Medical Center
  • Genitourinary Surgical Consultants
  • Oak Ridge Medical Plaza
  • Midtown Urology, P.C.
  • Atlantic Health Systems
  • Northeast Urogynecology
  • Medical University of Southern Carolina
  • Vanguard Urologic Institute
  • Integrity Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

device

sham

Arm Description

insertion of balloon system

cystoscopy with sham system

Outcomes

Primary Outcome Measures

Stamey Grade

Secondary Outcome Measures

Pad Weight
VLPP
I-QOL
Incontinence Episode Frequency

Full Information

First Posted
June 25, 2007
Last Updated
August 7, 2014
Sponsor
Solace Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00492596
Brief Title
The AttenueX IntraVesical System for the Treatment of Female Stress Urinary Incontinence
Official Title
An Evaluation of the AttenueX IntraVesical System in the Management of Female Subjects With Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solace Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
device
Arm Type
Experimental
Arm Description
insertion of balloon system
Arm Title
sham
Arm Type
Sham Comparator
Arm Description
cystoscopy with sham system
Intervention Type
Device
Intervention Name(s)
AttenueX IntraVesical System
Other Intervention Name(s)
Solace Balloon
Intervention Description
Insertion of the Solace AttenueX Intravesical System on Day 0
Intervention Type
Procedure
Intervention Name(s)
Sham Procedure
Intervention Description
Cystoscopy with Simulated Insertion of AttenuEX Intravescial System
Primary Outcome Measure Information:
Title
Stamey Grade
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Pad Weight
Time Frame
6-months
Title
VLPP
Time Frame
6-months
Title
I-QOL
Time Frame
6-months
Title
Incontinence Episode Frequency
Time Frame
6-months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Arizona Urologic Specialists
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
Tower Urology Institute for Incontinence
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Saad Juma Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Genitourinary Surgical Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Oak Ridge Medical Plaza
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Midtown Urology, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Atlantic Health Systems
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Northeast Urogynecology
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Medical University of Southern Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanguard Urologic Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Integrity Medical Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States

12. IPD Sharing Statement

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

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