NCT01054534

Brief Summary

Determine the ability of real-time ultrasound with fusion technology of prior acquired MRI of the pelvis to guide a needle to the second sacral foramen using the posterior approach and place a interstim lead.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 13, 2015

Status Verified

April 1, 2015

Enrollment Period

1.4 years

First QC Date

January 20, 2010

Last Update Submit

April 10, 2015

Conditions

Urinary Incontinence

Keywords

urinary incontinence

Outcome Measures

Primary Outcomes (1)

  • Identify the third sacral foramen of the pelvis through US image fusion technology

    at time of procedure

Study Arms (1)

Placement of interstim lead

OTHER

Placement of interstim lead using US image fusion technology

Procedure: Placement of interstim lead

Interventions

Placement of interstim leadPROCEDURE

Placement of insterstim lead using US image fusion technology

Placement of interstim lead

Eligibility Criteria

Age30 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient consented for Interstim lead placement

You may not qualify if:

  • Patients requesting not to be in the study.
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

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

  • Steven Clendenen, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 20, 2010

First Posted

January 22, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

April 13, 2015

Record last verified: 2015-04

Locations

US(1)