Urinary Incontinence, StressPhase 3NCT00492596
The AttenueX IntraVesical System for the Treatment of Female Stress Urinary Incontinence
A Phase 3 study testing AttenueX IntraVesical System in people with Urinary Incontinence, Stress, run by Solace Therapeutics, Inc. at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- AttenueX IntraVesical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 13 sitesUnited States
- Study dates
- Jun 2006to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Northeast Urogynecology
Albany, New York, 12205
Midtown Urology, P.C.
Atlanta, Georgia, 30308
Medical University of Southern Carolina
Charleston, South Carolina, 29425
Genitourinary Surgical Consultants
Denver, Colorado, 80220
Kaiser Permanente Medical Center
Downey, California, 90242
Oak Ridge Medical Plaza
Fort Lauderdale, Florida, 33334
Vanguard Urologic Institute
Houston, Texas, 77054
Tower Urology Institute for Incontinence
Los Angeles, California, 90048
Atlantic Health Systems
Morristown, New Jersey, 07960
Saad Juma Inc.
San Diego, California, 92024
Kaiser Permanente Medical Center
San Diego, California, 92120
Integrity Medical Research
Seattle, Washington, 98133
Arizona Urologic Specialists
Tucson, Arizona, 85712
About this study
Official title: An Evaluation of the AttenueX IntraVesical System in the Management of Female Subjects With Stress Urinary Incontinence
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.
Read the 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.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- AttenueX IntraVesical System, Sham Procedure
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AttenueX IntraVesical SystemDevice
Also called Solace Balloon
Insertion of the Solace AttenueX Intravesical System on Day 0
Sham ProcedureProcedure or surgery
Cystoscopy with Simulated Insertion of AttenuEX Intravescial System
| Study group | Role | What they receive |
|---|---|---|
| device | Experimental | insertion of balloon system Receives: Device: AttenueX IntraVesical System |
| sham | Sham comparator | cystoscopy with sham system Receives: Device: AttenueX IntraVesical System; Procedure: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stamey Grade
Measured: 6-months
Secondary outcomes (4)
Pad Weight
Measured: 6-months
VLPP
Measured: 6-months
I-QOL
Measured: 6-months
Incontinence Episode Frequency
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJun 2006
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solace Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492596
- Sponsor's protocol ID
- SOL2004-001
- Status last verified
- Aug 2014
- First submitted
- 25 Jun 2007
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the AttenueX IntraVesical System in the Management of Female Subjects With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00492596
- Acronym / sponsor ID
- SOL2004-001
- Conditions
- Urinary Incontinence, Stress
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Solace Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| device | Experimental | Device: AttenueX IntraVesical Systeminsertion of balloon system |
| sham | Sham comparator | Device: AttenueX IntraVesical System, Procedure: Sham Procedurecystoscopy with sham system |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AttenueX IntraVesical SystemAlso: Solace BalloonInsertion of the Solace AttenueX Intravesical System on Day 0 | Device | device, sham |
| Sham ProcedureCystoscopy with Simulated Insertion of AttenuEX Intravescial System | Procedure or surgery | sham |
Primary outcome
Stamey Grade
Time frame: 6-months
4 secondary outcomes
Pad Weight
Time frame: 6-months
VLPP
Time frame: 6-months
I-QOL
Time frame: 6-months
Incontinence Episode Frequency
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AttenueX IntraVesical System in people with Urinary Incontinence, Stress, run by Solace Therapeutics, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stamey Grade (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2014.