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Clinical Trial Summary

Treatment of overactive bladder (OAB) has been treated successfully by the injection of Botox. The Repris injection needle has a deflection that may assist in injection difficult to reach with standard straight needles. This study will assess the success, safety and patient tolerance of this new injection needle.


Clinical Trial Description

This is a prospective, multicenter, single arm study of the Repris injection needle to administer Botox to the bladder wall in patients with an overactive bladder. Following advancement of a cystoscope to the patient's bladder, the Repris needle will be advanced to the area of interest and into the bladder wall in order to administer the recommended volume of Botox. After injection, the needle will be removed and the procedure will be concluded. The patient will be asked to rank her tolerance of the procedure and level of discomfort using a standardized pain scale before being released. Five days after the procedure the patient will be contacted by telephone to determine whether any adverse events had occurred since release. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04982120
Study type Interventional
Source Uro-1 Medical
Contact Thomas Lawson, PhD
Phone 5102061794
Email drthomlawson@gmail.com
Status Recruiting
Phase N/A
Start date October 15, 2018
Completion date July 14, 2022

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