Injectable Bulking Agent Needle Guide

Phase 1

Terminated

• Conditions: Urinary Incontinence; Intrinsic Sphincter Deficiency

• Registration Number: NCT00763711
• Lead Sponsor: Carbon Medical Technologies

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-01
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-09
• Last Update Posted: 2012-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Advanced Urogynecology; 🇺🇸 West Chester, Ohio, United States