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Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control

Primary Purpose

Urge Incontinence, Urinary Retention

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Device Medtronic InterStim Tined Leads Models 3889 and 3093
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urge Incontinence focused on measuring Urinary urgency-frequency

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria: Signed and dated informed consent 16 years of age or greater Willing and able to complete voiding diaries and questionnaires at various time points during the study Located geographically near the physician, or willing and able to travel to the physician's site as necessary for all required visits Failed or is not a candidate for more conservative treatment Exclusion Criteria: Severe or uncontrolled diabetes; or diabetes with peripheral nerve involvement Pregnancy or planned pregnancy Concomitant medical conditions which would limit the success of the procedure such as: pelvic pain with uncertain etiology, active degenerative disc disease, spinal cord injury less than six months old, bleeding complications, or a cerebrovascular accident (CVA) less than six months old. Anatomical limitations that would prevent successful placement of an electrode Neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy or complete spinal cord injury (e.g., paraplegia) Subject characteristics indicating a poor understanding of the study or poor compliance with the study protocol (e.g. subjects with psychological and/or emotional problems, subjects unable to adequately operate equipment) Subjects with knowledge of planned magnetic resonance imaging (MRI), diathermy, microwave, high output ultrasonics, ultrasound scanning, or radiofrequency (RF) energy Mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture Symptomatic urinary tract infection (UTI). Upon completion of therapy for UTI, or if the subject is receiving prophylaxis for UTI, subjects can be considered for test stimulation or the full system implant (whichever is applicable) if symptom free for one month prior to the procedure. Subjects with other implantable neurostimulators, pacemakers, or defibrillators Primary stress incontinence or mixed incontinence where the stress component overrides the urge component Active participation in another clinical study

Sites / Locations

  • Contact Medtronic for specific site information
  • Contact Medtronic for site information

Outcomes

Primary Outcome Measures

Incidence of adverse events requiring surgical intervention
Incidence of lead migration

Secondary Outcome Measures

Incidence of infection

Full Information

First Posted
September 12, 2005
Last Updated
November 14, 2013
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT00225966
Brief Title
Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control
Official Title
Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Study design was changed and is now InSite trial #1634 - See NCT00547378
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
MedtronicNeuro

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is assess the long-term safety and effectiveness of the InterStim tined lead using a minimally invasive approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Incontinence, Urinary Retention
Keywords
Urinary urgency-frequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
153 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Device Medtronic InterStim Tined Leads Models 3889 and 3093
Primary Outcome Measure Information:
Title
Incidence of adverse events requiring surgical intervention
Title
Incidence of lead migration
Secondary Outcome Measure Information:
Title
Incidence of infection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Eligibility Criteria
Inclusion Criteria: Signed and dated informed consent 16 years of age or greater Willing and able to complete voiding diaries and questionnaires at various time points during the study Located geographically near the physician, or willing and able to travel to the physician's site as necessary for all required visits Failed or is not a candidate for more conservative treatment Exclusion Criteria: Severe or uncontrolled diabetes; or diabetes with peripheral nerve involvement Pregnancy or planned pregnancy Concomitant medical conditions which would limit the success of the procedure such as: pelvic pain with uncertain etiology, active degenerative disc disease, spinal cord injury less than six months old, bleeding complications, or a cerebrovascular accident (CVA) less than six months old. Anatomical limitations that would prevent successful placement of an electrode Neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy or complete spinal cord injury (e.g., paraplegia) Subject characteristics indicating a poor understanding of the study or poor compliance with the study protocol (e.g. subjects with psychological and/or emotional problems, subjects unable to adequately operate equipment) Subjects with knowledge of planned magnetic resonance imaging (MRI), diathermy, microwave, high output ultrasonics, ultrasound scanning, or radiofrequency (RF) energy Mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture Symptomatic urinary tract infection (UTI). Upon completion of therapy for UTI, or if the subject is receiving prophylaxis for UTI, subjects can be considered for test stimulation or the full system implant (whichever is applicable) if symptom free for one month prior to the procedure. Subjects with other implantable neurostimulators, pacemakers, or defibrillators Primary stress incontinence or mixed incontinence where the stress component overrides the urge component Active participation in another clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medtronic Investigator
Organizational Affiliation
Medtronic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Contact Medtronic for specific site information
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Contact Medtronic for site information
City
Minneapolis
State/Province
Minnesota
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control

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