Urge IncontinenceNCT00225966
Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control
A study testing Device Medtronic InterStim Tined Leads Models 3889 and 3093 in people with Urge Incontinence and Urinary Retention, run by MedtronicNeuro at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Urge Incontinence, Urinary Retention
- What is being tested?
- Device Medtronic InterStim Tined Leads Models 3889 and 3093
- Type of treatment
- Medical device
- How many people
- 153 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2004to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Contact Medtronic for specific site information
Los Angeles, California
Contact Medtronic for site information
Minneapolis, Minnesota
About this study
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
- Being tested
- Device Medtronic InterStim Tined Leads Models 3889 and 3093
- Keywords
- Urinary urgency-frequency
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device Medtronic InterStim Tined Leads Models 3889 and 3093Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events requiring surgical intervention
Incidence of lead migration
Secondary outcomes (1)
Incidence of infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startAug 2004
- Study completionOct 2007
Why it stopped: Study design was changed and is now InSite trial #1634 - See NCT00547378
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urge IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medtronic Investigator, Principal investigator, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225966
- Sponsor's protocol ID
- MGU-003
- Status last verified
- Nov 2013
- First submitted
- 12 Sep 2005
- Last updated
- 15 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control
- ClinicalTrials.gov ID
- NCT00225966
- Acronym / sponsor ID
- MGU-003
- Conditions
- Urge Incontinence, Urinary Retention
- Keywords
- Urinary urgency-frequency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study design was changed and is now InSite trial #1634 - See NCT00547378
- Enrolment
- 153 participants
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Study completion
- Oct 2007
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is assess the long-term safety and effectiveness of the InterStim tined lead using a minimally invasive approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device Medtronic InterStim Tined Leads Models 3889 and 3093 | Device | – |
Primary outcome
Incidence of adverse events requiring surgical intervention
Incidence of lead migration
1 secondary outcome
Incidence of infection
Results and safety
The study was stopped early (reason given: Study design was changed and is now InSite trial #1634 - See NCT00547378). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
Related trials for Urge Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Recruiting
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
Urge Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medtronic Investigator principal investigator
Medtronic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device Medtronic InterStim Tined Leads Models 3889 and 3093 in people with Urge Incontinence and Urinary Retention, run by MedtronicNeuro at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study design was changed and is now InSite trial #1634 - See NCT00547378). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events requiring surgical intervention. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2013.