Clinical trial NCT00225966: 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
Overall status: TERMINATED
Phase: NA
Conditions: Urge Incontinence
Urinary Retention
Keywords: Urinary urgency-frequency
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2005-09-26
Enrollment: 153
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of adverse events requiring surgical intervention
measure: Incidence of lead migration
Secondary outcomes:
measure: Incidence of infection
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Contact Medtronic for specific site information
state: California
city: Minneapolis
country: United States
facility: Contact Medtronic for site information
state: Minnesota
Study officials:
affiliation: Medtronic
name: Medtronic Investigator
role: PRINCIPAL_INVESTIGATOR
References: