NCT00492596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_3

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 11, 2014

Status Verified

August 1, 2014

Enrollment Period

4.8 years

First QC Date

June 25, 2007

Last Update Submit

August 7, 2014

Conditions

Urinary Incontinence, Stress

Outcome Measures

Primary Outcomes (1)

  • Stamey Grade

    6-months

Secondary Outcomes (4)

  • Pad Weight

    6-months

  • VLPP

    6-months

  • I-QOL

    6-months

  • Incontinence Episode Frequency

    6-months

Study Arms (2)

device

EXPERIMENTAL

insertion of balloon system

Device: AttenueX IntraVesical System

sham

SHAM COMPARATOR

cystoscopy with sham system

Device: AttenueX IntraVesical SystemProcedure: Sham Procedure

Interventions

AttenueX IntraVesical SystemDEVICE

Insertion of the Solace AttenueX Intravesical System on Day 0

Also known as: Solace Balloon
devicesham
Sham ProcedurePROCEDURE

Cystoscopy with Simulated Insertion of AttenuEX Intravescial System

sham

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or planning pregnancy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Arizona Urologic Specialists

Tucson, Arizona, 85712, United States

Location

Kaiser Permanente Medical Center

Downey, California, 90242, United States

Location

Tower Urology Institute for Incontinence

Los Angeles, California, 90048, United States

Location

Saad Juma Inc.

San Diego, California, 92024, United States

Location

Kaiser Permanente Medical Center

San Diego, California, 92120, United States

Location

Genitourinary Surgical Consultants

Denver, Colorado, 80220, United States

Location

Oak Ridge Medical Plaza

Fort Lauderdale, Florida, 33334, United States

Location

Midtown Urology, P.C.

Atlanta, Georgia, 30308, United States

Location

Atlantic Health Systems

Morristown, New Jersey, 07960, United States

Location

Northeast Urogynecology

Albany, New York, 12205, United States

Location

Medical University of Southern Carolina

Charleston, South Carolina, 29425, United States

Location

Vanguard Urologic Institute

Houston, Texas, 77054, United States

Location

Integrity Medical Research

Seattle, Washington, 98133, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 27, 2007

Study Start

June 1, 2006

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

August 11, 2014

Record last verified: 2014-08

Locations

US(13)