(Stress Urinary Incontinence)
About the Vesair®
Bladder Control Procedure
About The VESICAL
If you are a post-menopausal female, and experience urine leakage when you laugh, cough, sneeze, or during exercise, you may qualify to participate in the VESICAL Clinical Trial. This trial will be conducted in several cities throughout the United States. Up to 90 women will be allowed to participate.
If you qualify and choose to join the VESICAL Clinical Trial, you will be treated by a trained bladder specialist and will receive all study-related care at no cost. This includes the Vesair Bladder Control procedure, as well as all examinations or visits required for the study.
As a participant in the VESICAL Clinical Trial you will need to be available to attend all study related follow-up visits over a minimum of 12 months. After the initial twelve months you may elect to continue to receive the treatment for an additional two years. All patients who enter the VESICAL Clinical Trial will receive the treatment.
If you answered "YES" to each of the above questions, click here find a Vesical Clinical Site
Select the nearest enrolling trial site to be contacted for further evaluation of your eligibility and to determine if you are good candidate to participate in Vesical Trial:
Clinical Study SiteStudy CoordinatorSelect Your Location Below
West Penn HospitalPittsburgh, PA 15224Nichelle LlewellynContact Form
The Institute for Female Pelvic MedicineAllentown, PA 18103Eileen TaffContact Form
Mainline Health - Riddle HospitalMedia, PA 19063Kirstin LiuContact Form
Georgia Center for WomenAtlanta, GA 30312Felica ThomasContact Form
Regional Urology AssociatesShreveport, LA 71106Leah Stehr RenfroContact Form
1. The Journal of Urology, Vol. 190 No. 6, 2013. "A Randomized, Controlled Trial of a Novel Intravesical Attenuation Device for the Treatment of Stress Urinary Incontinence.".
2. European Study Participant's feedback.
3. The Journal of Urology, Vol. 190 No. 6, 2013. “A Randomized, Controlled Trial of a Novel Intravesical Attenuation Device for the Treatment of Stress Urinary Incontinence.”
4. Neurourology and Urodynamics, Vol. 35 2016. “A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females.”
The purpose of this clinical trial is to continue the evaluation of the performance of the Vesair® Bladder Control procedure in post-menopausal women that have Stress Urinary Incontinence (SUI). The VESICAL Clinical Trial will follow a carefully controlled protocol (a plan that details what researchers will do during the trial). As a clinical trial progresses, researchers report the results of the trial at scientifc meetings, to medical journals and to various government agencies. Individual participants’ names will remain completely confdential and will not be mentioned in these reports.
If you qualify and choose to join the VESICAL Clinical Trial, you will be treated by a trained bladder specialist and will receive all study-related care at no cost. This includes the Vesair Bladder Control procedure, as well as all examinations or visits required for the study. As a participant in the VESICAL Clinical Trial you will visit your study doctor’s office approximately four (4) times over twelve (12) months to be evaluated and provide feedback about your experience.
YES. The Vesair Bladder Control Procedure has been evaluated in 450 women in three clinical trials in the United States and Europe. 3, 4
What some women are saying about
the Vesair Bladder Control procedure2:
...I am more carefree.
...No more pads needed, a dry feeling.
...I can be away from home for longer periods
and don't need to use any pads anymore.
...Less worries when I'm getting ready to go out.
Thank you for your interest in the VESICAL Clinical Trial.
(Vesair® Continued Access Trial)