Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
7 participants
INTERVENTIONAL
2017-03-09
2019-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vesair Clinical Trial
NCT04026347
Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder
NCT00821184
Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms
NCT00463541
Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder
NCT00454740
A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.
NCT00333112
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vesair Arm
Subjects treated with the Vesair Bladder Control System at enrollment.
Vesair Bladder Control System
Intravesical balloon
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vesair Bladder Control System
Intravesical balloon
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Maximum score on IQOL of 60
* Positive cough test for leakage
* Willing to undergo procedures
* Free from infection
* Have previously tried (and failed) noninvasive treatment for SUI
Exclusion Criteria
* Urge-predominant mixed incontinence
* Incontinence of neurogenic etiology
* 2 or more UTIs in past year and 1 in past 3 months
* Surgery for SUI in the past 6 months
* taking medication that can be used to treat SUI
* taking medication that affects urinary symptoms for less than 3 months
* undergoing biofeedback
* Grade 3 or worse cystocele
* last menstrual period within 12 months
* oral progesterone or estrogen in the past 12 months
* BMI \> 40
* involuntary detrusor contractions or discomfort during bladder filling
* previous stage III or worse cancer
* previous cancer of the urinary tract
* previous symptoms for early stage cancer in the past 2 years
* anticoagulation therapy other than aspirin
* history of prosthetic heart valve
* neurological or connective tissue condition or disease affecting bladder function
* known allergy to device components
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Solace Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kaiser Permanente Urology
Los Angeles, California, United States
Kaiser Permanente Urogynecology
San Diego, California, United States
Georgia Center for Women
Atlanta, Georgia, United States
Regional Urology
Shreveport, Louisiana, United States
Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States
Riddle Hospital, Main Line Health
Media, Pennsylvania, United States
West Penn Hospital, Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CD1007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.