Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
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|ClinicalTrials.gov Identifier: NCT04115228|
Recruitment Status : Active, not recruiting
First Posted : October 3, 2019
Last Update Posted : January 13, 2021
Study objectives: To report feasibility data for safety and effectiveness of the study device.
Study device: Nine Continents Medical implantable tibial nerve stimulator (ITNS) model 9C-680 with programmer model 9C-580.
Intended use: The study device is intended for treatment of the symptoms of overactive bladder (OAB), including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.
Type of design: Single-arm longitudinal design.
Study sites: Single site, in the United States.
Study duration: One year total, comprising six months for enrolling and implanting 10 subjects, and 26 weeks for follow-up.
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Device: Implantation and neuromodulation therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)|
|Actual Study Start Date :||October 9, 2019|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||April 30, 2021|
Experimental: Study device
Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks.
Device: Implantation and neuromodulation therapy
The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.
Other Name: Nine Continents Medical ITNS model 9C-680
- Adverse events [ Time Frame: 26 weeks ]Incidence, severity, and relatedness of all adverse events and device deficiencies.
- Improvement from baseline of urgency urinary incontinence [ Time Frame: 13 weeks ]Percentage decrease in number of episodes in a 3-day diary
- Improvement from baseline of voiding frequency [ Time Frame: 13 weeks ]Percentage decrease in number of voids during waking hours exceeding 7 in a 3-day diary
- Improvement from baseline of nocturia [ Time Frame: 13 weeks ]Percentage decrease in number of voids awakening from sleep in a 3-day diary
- Improvement from baseline of voids with urgency [ Time Frame: 13 weeks ]Percentage decrease in number of voids self-reported with moderate to severe urgency
- Threshold [ Time Frame: 13 weeks ]Stability of neuromodulation pulse amplitude required to evoke paresthesia or motor response ("threshold").
- Quality of life - symptom bother [ Time Frame: 13 weeks ]Improvement from baseline of: overactive bladder symptom and health-related quality of life questionnaire (OAB-q), short form symptom bother
- Quality of life - global [ Time Frame: 13 weeks ]Improvement from baseline of: global response assessment (GRA)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115228
|United States, California|
|San Ramon, California, United States, 94583|
|Principal Investigator:||Parminder Sethi, M.D.||Pacific Urology|