Overactive Bladder
Conditions
Brief summary
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.)
Interventions
Tibial neuromodulation (TNM) devices are implantable devices that provide stimulation to the tibial nerve.
Sponsors
MedtronicNeuro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Primary Inclusion Criteria: 1. Subjects 18 years of age or older 2. Have a diagnosis for at least 6 months of OAB 3. No OAB pharmacotherapy for 2 weeks prior to the baseline voiding diary 4. Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system and comply with the study protocol 5. Willing and able to provide signed and dated informed consent Primary
Exclusion criteria
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury 2. Severe uncontrolled diabetes 3. History of urinary retention within the previous 6 months 4. Current symptomatic urinary tract infection 5. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component 6. Current urinary tract mechanical obstruction 7. Have knowledge of planned magnetic resonance imaging (MRIs) or diathermy 8. History of a prior implantable tibial neuromodulation system 9. Skin lesions or compromised skin integrity at the implant site 10. Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device 11. Previous pelvic floor surgery in the last 6 months 12. Women who are pregnant or planning to become pregnant 13. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements. 14. Any subject who is considered to be part of a vulnerable patient population. 15. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To characterize the TNM device implant procedure | 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 | 14 days | This information will be collected through programming and device data at implant through the 14-day follow-up visit. |
Countries
United States
Outcome results
None listed