The purpose of this clinical trial is to evaluate the safety and performance of a the Vesair Bladder Control balloon in women that have Stress Urinary Incontinence (SUI). The SUCCESS 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 scientific meetings, to medical journals and to various government agencies. Individual participants' names will remain completely confidential and will not be mentioned in these reports.
No, The Vesair Bladder Control procedure has been evaluated in two controlled, randomized clinical trials in the US and Europe. Over 200 women enrolled in these studies. Treatment outcomes in the first US trial have been published in a peer-reviewed clinical journal.1
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.
If you are a female 18 or older and experience urine leakage when you laugh, cough, sneeze, or during exercise, you may qualify to participate in the SUCCESS Clinical Trial. This trial will be conducted in several cities throughout the United States. Up to 220 women will be allowed to participate.
If you qualify and choose to join the SUCCESS 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 SUCCESS 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 SUCCESS Clinical Trial will receive the treatment. Some patients will receive the Vesair Balloon at the initial enrollment period, others will receive it during their three (3) month scheduled visit.
Participating in a clinical study enables people to play a more active role in their own health care, gain access to new experimental treatments before they are widely available, and help others by contributing to medical research. Participating in any clinical trial is completely voluntary. Your willingness to consider the SUCCESS Clinical Trial is greatly appreciated and will make a difference in the lives of many women.
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.
Thank you for your interest in the SUCCESS Clinical Trial. This trial is no longer recruiting patients.
(Stress Urinary inContinence Control Efficacy and Safety Study)