PFD Week 2016-12 Month In-Dwelling Intravesical Air-Filled Balloon Remocal Followed by New Balloon Replacement Per the Success Clinical Trial Protocal

12 Month In-Dwelling Intravesical Air-Filled Balloon Remocal Followed by New Balloon Replacement Per the Success Clinical Trial Protocal

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Video Transcription

Video Summary

The Viscera Bladder Control Balloon is an investigational device for treating female stress urinary incontinence. It reduces rapid increases in bladder pressure using a compressible air-filled balloon. The video shows the examination, removal, and insertion of a new balloon according to the SUCCESS clinical trial protocol. A cystoscopic sheath is placed in the urethra, and a rigid rod lens scope is used to examine the balloon before removal. The deflated balloon is punctured and removed through the sheath using a specially designed grasper. A new balloon is prepared with a delivery catheter and injected with airlock and air. The inflated balloon is examined and the procedure concludes. The video is part of the SUCCESS clinical trial aimed at assessing the device's safety and effectiveness, with data pending submission to the FDA.

Asset Subtitle

Denise Elser, MD

Meta Tag

Category Urinary Incontinence

Category Surgery - Novel Procedures

Keywords

Viscera Bladder Control Balloon

female stress urinary incontinence

compressible air-filled balloon

SUCCESS clinical trial

device's safety and effectiveness