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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Injection of Botox
Georgia Urology
Cartersville, Georgia, United States
RECRUITINGProcedure Success
Percentage of subjects with successful injection of medication
Time frame: 1 Day of the procedure
Patient Tolerance of Injection
Level of pain from use of the needle measured on Likert Scale 1 to 5
Time frame: 1 Day of the procedure
Adverse Events during Procedure
Incidence and Severity of Adverse events associated with the injection
Time frame: Day 0 and Day 5
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