Urge Incontinence, Urinary Retention
Conditions
Keywords
Urinary urgency-frequency
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.
Interventions
DEVICEDevice Medtronic InterStim Tined Leads Models 3889 and 3093
Sponsors
MedtronicNeuro
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events requiring surgical intervention | — |
| Incidence of lead migration | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of infection | — |
Countries
United States
Outcome results
None listed