The purpose of this study is to evaluate the use of the Needle Guide as an assist in properly guiding an injection needle into the appropriate tissue plane during an injectable bulking agent procedure in women using a FDA approved injectable bulking agent. The injectable bulking agent will be Durasphere EXP.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Bulking Agent injection using a needle guide
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Advanced Urogynecology
West Chester, Ohio, United States
to evaluate the consistency of the location of the injection site and resulting location of bulking effect
Time frame: at procedure
Safety will be demonstrated through an analysis of morbidity and complication rates, (if any), associated with the use of the Needle Guide.
Time frame: 1 week
to evaluate the comparative ease of the injection procedure using the Bulking Agent Needle Guide as compared to the traditional transurethral or periurethral injection technique.
Time frame: at procedure
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