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

Medtronic

Status

Terminated

Conditions

Urinary Retention

Urge Incontinence

Treatments

Device: Device Medtronic InterStim Tined Leads Models 3889 and 3093

Study type

Interventional

Funder types

Industry

Identifiers

NCT00225966

MGU-003

Details and patient eligibility

About

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

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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