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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2007-10-31

Brief Summary

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

Detailed Description

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Conditions

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Urge Incontinence Urinary Retention

Keywords

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Urinary urgency-frequency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Device Medtronic InterStim Tined Leads Models 3889 and 3093

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Medtronic Investigator

Role: PRINCIPAL_INVESTIGATOR

Medtronic

Locations

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Contact Medtronic for specific site information

Los Angeles, California, United States

Site Status

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Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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MGU-003

Identifier Type: -

Identifier Source: org_study_id