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

Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00225966
• Other study ID #: MGU-003
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: November 14, 2013
• Start date: August 2004
• Est. completion date: October 2007

Study information

• Verified date: November 2013
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 153
• Est. completion date: October 2007
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urge Incontinence
• Urinary Incontinence, Urge
• Urinary Retention

Intervention

Device:
• Device Medtronic InterStim Tined Leads Models 3889 and 3093

Locations

Country	Name	City	State
United States	Contact Medtronic for specific site information	Los Angeles	California
United States	Contact Medtronic for site information	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events requiring surgical intervention
Primary	Incidence of lead migration
Secondary	Incidence of infection