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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 VESICAL Clinical Trial. This trial will be conducted in several cities throughout the United States. Up to 90 women will be allowed to participate.

What should I expect?

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.

Do you answer "YES" to each of the following
six questions:

  1. You leak urine when you laugh, cough, sneeze or while exercising?
  2. You are postmenopausal? (Last menstruation period was greater than twelve months ago.)
  3. You have failed pelvic (Kegel) exercises?
  4. You are moderately to highly bothered by your bladder leaks?
  5. You are not interested in a permanent surgical solution?
  6. You are looking to reduce your leakage by at least by 50%?

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.”

What is the purpose of the
VESICAL 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 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.

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. 3, 4

  • 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:
  • An improvement in their incontinence symptoms
  • A reduction in the frequency of their daily leakage events
  • Improvement in their quality of life
  • A reduction in the amount of urine leakage

What some women are saying about
the Vesair Bladder Control procedure
2:

...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)