Intrinsic Sphincter Deficiency, Urinary Incontinence
Conditions
Keywords
Urinary Incontinence, ISD
Brief summary
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.
Interventions
DEVICENeedle Guided Periurethral Injection
Bulking Agent injection using a needle guide
Sponsors
Carbon Medical Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
Individuals satisfying the Indications and Contraindications criteria in the Durasphere EXP Directions for Use may participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to evaluate the consistency of the location of the injection site and resulting location of bulking effect | at procedure |
| Safety will be demonstrated through an analysis of morbidity and complication rates, (if any), associated with the use of the Needle Guide. | 1 week |
Secondary
| Measure | Time frame |
|---|---|
| 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. | at procedure |
Countries
United States
Outcome results
None listed