NCT00763711

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

January 10, 2012

Status Verified

January 1, 2012

Enrollment Period

1.4 years

First QC Date

September 29, 2008

Last Update Submit

January 9, 2012

Conditions

Urinary IncontinenceIntrinsic Sphincter Deficiency

Keywords

Urinary IncontinenceISD

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Injection with Needle Guide

EXPERIMENTAL
Device: Needle Guided Periurethral Injection

Interventions

Needle Guided Periurethral InjectionDEVICE

Bulking Agent injection using a needle guide

Injection with Needle Guide

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Individuals satisfying the "Indications" and "Contraindications" criteria in the Durasphere EXP Directions for Use may participate.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Advanced Urogynecology

West Chester, Ohio, 45069, United States

Location

Related Links

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dean Klein

    Carbon Medical Technologies

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2008

First Posted

October 1, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 10, 2012

Record last verified: 2012-01

Locations

US(2)