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

NCT00225966 | Terminated

• 1 other identifier: MGU-003
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 2

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.

Conditions

Urge Incontinence; Urinary Retention

Keywords

Urinary urgency-frequency

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events requiring surgical intervention

• Incidence of lead migration

Secondary Outcomes (1)

• Incidence of infection

Interventions

Device Medtronic InterStim Tined Leads Models 3889 and 3093 DEVICE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (2)

Contact Medtronic for specific site information

Los Angeles, California, United States

Location

Contact Medtronic for site information

Minneapolis, Minnesota, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Retention

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medtronic Investigator

  Medtronic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 26, 2005
• Study Start: August 1, 2004
• Study Completion: October 1, 2007
• Last Updated: November 15, 2013

Record last verified: 2013-11

Locations

US (2)