Overactive BladderBASICNCT04016324
InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study
A study testing InterStim Basic Evaluation lead and foramen needle in people with Overactive Bladder and Urinary Urge Incontinence, run by MedtronicNeuro at 15 sites in 4 countries.
Trial summary
Post-market clinical follow-up for continued assessment of safety and performance of the InterStim basic evaluation lead and foramen needle(s) used during a therapy evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder, Urinary Urge Incontinence, Urgency-frequency Syndrome
- What is being tested?
- InterStim Basic Evaluation lead and foramen needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 28 Nov 2019to 9 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18 years of age or older
- Candidate for sacral neuromodulation in accordance with the InterStim System labeling
- Have a diagnosis of overactive bladder (OAB) as demonstrated by either urinary urge incontinence and/or urinary frequency on a 3-day voiding diary
- Willing and able to accurately complete study diaries, questionnaire, attend visits, and comply with the study protocol
- Willing and able to provide signed and dated informed consent
Who cannot join
- Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
- Have implantable pacemakers, or defibrillators
- Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the InterStim System labeling
- Women who are pregnant or planning to become pregnant during participation in the study
- Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements
- Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
United States10 sites
Urology Partners of North Texas
Arlington, Texas, 76017
Urologic Research and Consulting
Englewood, New Jersey, 07631
Wright State Physicians
Fairborn, Ohio, 45234-2640
Prisma Health
Greenville, South Carolina, 29605-4627
FirstHealth Urogynecology
Hamlet, North Carolina, 28345
Minnesota Urology (Plymouth)
Plymouth, Minnesota, 55441
Pinellas Urology
St. Petersburg, Florida, 33710
Florida Urology Partners
Tampa, Florida, 33606
Urology of Virginia
Virginia Beach, Virginia, 23642-1815
Southern Urogynecology
West Columbia, South Carolina, 29169-3456
United Kingdom3 sites
The Bristol Urological Institute
Bristol, BS10 5NB
The Newcastle upon Tyne Hospitals
Newcastle upon Tyne, NE7 7DN
Salford Royal NHS Foundation Trust
Salford, M68HD
About this study
Official title: InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study
Post-market clinical follow-up for continued assessment of safety and performance of the InterStim basic evaluation lead and foramen needle(s) used during a therapy evaluation.
- Being tested
- InterStim Basic Evaluation lead and foramen needle
- Keywords
- Overactive Bladder, Urinary Urge Incontinence, Urgency-frequency Syndrome
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterStim Basic Evaluation lead and foramen needleDevice
Commercial devices within their intended use as described in approved Instructions for Use.
| Study group | Role | What they receive |
|---|---|---|
| Basic evaluation | Other | Subjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit. Receives: Device: InterStim Basic Evaluation lead and foramen needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor or Sensory Response(s) During Lead Placement - by Subject
To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim basic evaluation lead.
A motor or sensory response was determined at the time of lead placement. Amplitude was titrated up from 0 until a response was reported and/or observed. A sensory response was defined as the lowest amplitude where the subject first perceived sensation of the stimulation. A motor response was defined as the lowest amplitude of electrical stimulation where a motor response (e.g. bellows response, anal wink and/or plantar flexion of the big toe) was observed.
Measured: During lead implant procedure (approximately 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start28 Nov 2019
- Primary completion6 Oct 2020
- Study completion9 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- To characterize proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim Basic Evaluation Lead.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BASIC Clinical Research Study Team, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016324
- Sponsor's protocol ID
- MDT19002
- Acronym
- BASIC
- Status last verified
- Nov 2021
- First submitted
- 9 Jul 2019
- Last updated
- 23 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study
- ClinicalTrials.gov ID
- NCT04016324
- Acronym / sponsor ID
- BASIC / MDT19002
- Keywords
- Overactive Bladder, Urinary Urge Incontinence, Urgency-frequency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Posted 23 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-market clinical follow-up for continued assessment of safety and performance of the InterStim basic evaluation lead and foramen needle(s) used during a therapy evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To characterize proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim Basic Evaluation Lead.
| Arm | Type | Receives |
|---|---|---|
| Basic evaluation | Other | Device: InterStim Basic Evaluation lead and foramen needleSubjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects 18 years of age or older
- Candidate for sacral neuromodulation in accordance with the InterStim System labeling
- Have a diagnosis of overactive bladder (OAB) as demonstrated by either urinary urge incontinence and/or urinary frequency on a 3-day voiding diary
- Willing and able to accurately complete study diaries, questionnaire, attend visits, and comply with the study protocol
- Willing and able to provide signed and dated informed consent
Key exclusion criteria (7 listed)
- Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
- Have implantable pacemakers, or defibrillators
- Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the InterStim System labeling
- Women who are pregnant or planning to become pregnant during participation in the study
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 |
|---|---|---|
| InterStim Basic Evaluation lead and foramen needleCommercial devices within their intended use as described in approved Instructions for Use. | Device | Basic evaluation |
Primary outcome
Motor or Sensory Response(s) During Lead Placement - by Subject
Time frame: During lead implant procedure (approximately 20 minutes)
To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim basic evaluation lead. A motor or sensory response was determined at the time of lead placement. Amplitude was titrated up from 0 until a response was reported and/or observed. A sensory response was defined as the lowest amplitude where the subject first perceived sensation of the stimulation. A motor response was defined as the lowest amplitude of electrical stimulation where a motor response (e.g. bellows response, anal wink and/or plantar flexion of the big toe) was observed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
BASIC Clinical Research Study Team study director
Medtronic
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InterStim Basic Evaluation lead and foramen needle in people with Overactive Bladder and Urinary Urge Incontinence, run by MedtronicNeuro at 15 sites in 4 countries.
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 7 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: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, United Kingdom, Canada, Netherlands. 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?
Yes. Results are posted in the registry (first posted 23 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Motor or Sensory Response(s) During Lead Placement - by Subject (time frame: During lead implant procedure (approximately 20 minutes)). 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 23 Nov 2021.