Overactive BladderTITAN 1NCT04873271
Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study
A study testing Medtronic Implantable Tibial Neuromodulation (TNM) System in people with Overactive Bladder, run by MedtronicNeuro at 7 sites in United States.
Trial summary
This is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM device in subjects with overactive bladder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Medtronic Implantable Tibial Neuromodulation (TNM) System
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 May 2021to 8 Jul 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Primary Inclusion Criteria:
- Subjects 18 years of age or older
- Have a diagnosis for at least 6 months of OAB
- No OAB pharmacotherapy for 2 weeks prior to the baseline voiding diary
- Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system and comply with the study protocol
- Willing and able to provide signed and dated informed consent
Primary Exclusion Criteria:
- Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
- Severe uncontrolled diabetes
- History of urinary retention within the previous 6 months
- Current symptomatic urinary tract infection
- Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- Current urinary tract mechanical obstruction
- Have knowledge of planned magnetic resonance imaging (MRIs) or diathermy
- History of a prior implantable tibial neuromodulation system
- Skin lesions or compromised skin integrity at the implant site
- Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device
- Previous pelvic floor surgery in the last 6 months
- Women who are pregnant or planning to become pregnant
- Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
- Any subject who is considered to be part of a vulnerable patient population.
- Concurrent participation in another clinical study that may add additional safety risks and/or confound study results. Subjects in concurrent studies can only be enrolled with permission from Medtronic.
Contact Medtronic's study manager to determine if the subject can be enrolled in both studies.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Urology Partners of North Texas
Arlington, Texas, 76015
Urologic Research and Consulting
Englewood, New Jersey, 07631
Prisma Health
Greenville, South Carolina, 29605
FirstHealth Urogynecology
Hamlet, North Carolina, 28345
Georgia Urology
Marietta, Georgia, 30060
Milwaukee Urogynecology Ascension Medical Group
Milwaukee, Wisconsin, 53211
Sanford Health
Sioux Falls, South Dakota, 57105
About this study
This is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM device in subjects with overactive bladder.
Read the detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
- Conditions
- Overactive Bladder
- Being tested
- Medtronic Implantable Tibial Neuromodulation (TNM) System
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Implantable Tibial Neuromodulation (TNM) SystemDevice
Tibial neuromodulation (TNM) devices are implantable devices that provide stimulation to the tibial nerve.
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the TNM device implant procedure
This information will be collected through a series of questions for participating investigators via a case report form at implant through the 14-day follow-up visit.
Measured: 14 days
To characterize the TNM device initial system use
This information will be collected through programming and device data at implant through the 14-day follow-up visit.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start11 May 2021
- Primary completion4 Aug 2021
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Miller, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873271
- Sponsor's protocol ID
- MDT20033
- Acronym
- TITAN 1
- Status last verified
- Jul 2022
- First submitted
- 28 Apr 2021
- Last updated
- 13 Jul 2022
- Results posted
- No
- 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 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study
- ClinicalTrials.gov ID
- NCT04873271
- Acronym / sponsor ID
- TITAN 1 / MDT20033
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 11 May 2021 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 5 May 2021 (actual)
- 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.
This is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM device in subjects with overactive bladder.
Detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Medtronic Implantable Tibial Neuromodulation (TNM) SystemTibial neuromodulation (TNM) devices are implantable devices that provide stimulation to the tibial nerve. | Device | – |
Primary outcome
To characterize the TNM device implant procedure
Time frame: 14 days
This information will be collected through a series of questions for participating investigators via a case report form at implant through the 14-day follow-up visit.
To characterize the TNM device initial system use
Time frame: 14 days
This information will be collected through programming and device data at implant through the 14-day follow-up visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- 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.
Anne Miller study director
Medtronic
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Implantable Tibial Neuromodulation (TNM) System in people with Overactive Bladder, run by MedtronicNeuro at 7 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?
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 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To characterize the TNM device implant procedure (time frame: 14 days). 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 13 Jul 2022.