About the Vesair Clinical Trial

A Clinical Trial is Underway to Evaluate the Safety and Performance of the Vesair® Bladder Control Procedure.

Am I a candidate?

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 Vesair Clinical Trial.

What should I expect?

If you qualify and choose to join the Vesair 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 Vesair 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.

If you decide to enroll in the Vesair Clinical Study, you will be compensated for your time.

What is the purpose of the Vesair Clinical Trial?

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 Vesair Clinical Trial will follow a carefully controlled protocol (a plan that details what researchers will do during the trial).

Has the Vesair® Bladder Control Procedure been studied before now?

YES. The Vesair Bladder Control Procedure has been evaluated in 450 women in three clinical trials in the United States and Europe. 1, 2

• There were no complications that impacted patient’s long term health or bladder function.
• Any and all side effects, including urinary tract infection, dysuria, or frequency, were resolved either by accommodating, medication, or balloon removal.
• Although rare, some women may require sedation during cystoscopy as they may not tolerate their bladder being filled with fluid.
• A majority of the patients reported:

1. An improvement in their incontinence symptoms
2. A reduction in the frequency of their daily leakage events
3. Improvement in their quality of life
4. A reduction in the amount of urine leakage

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. 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.”