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| ID | Type | Description | Link |
|---|---|---|---|
| R44DK121578 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study device | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation and neuromodulation therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change of Urinary Incontinence Frequency From Baseline to 13 Weeks | For a participant analyzed, let x0 = average number of voids with leakage per 24 hours in first 72 hours of baseline diary, x1 = average number of voids with leakage per 24 hours in first 72 hours of 13-week diary, and x = percent change of urinary incontinence frequency from baseline to 13 weeks. Then x = 100 * (x1 - x0) / x0. For example, a participant with an average of 4 voids with leakage per 24 hours in the first 72 hours of the baseline diary and 2 voids with leakage per 24 hours in the first 72 hours of the 13-week diary would have a percent change of urinary incontinence frequency from baseline to 13 weeks of 100 * (2 - 4) / 4 = -50. | Baseline to 13 weeks |
| Percent Change of Excess Voiding Frequency During Waking Hours From Baseline to 13 Weeks | For a participant analyzed, let x0 = average number of voids during waking hours per 24 hours in first 72 hours of baseline diary, x1 = average number of voids during waking hours per 24 hours in first 72 hours of 13-week diary, and x = percent change of excess voiding frequency during waking hours from baseline to 13 weeks, where "excess" means voids during waking hours exceeding 7 per 24 hours. Then x = 100 * (x1 - x0) / (x0 - 7). For example, a participant with an average of 16 voids during waking hours per 24 hours in the first 72 hours of the baseline diary and an average of 10 voids during waking hours per 24 hours during the first 72 hours of the 13-week diary would have a percent change of excess voiding frequency during waking hours from baseline to 13 weeks of 100 * (10 - 16) / (16 - 7) = -67. | Baseline to 13 weeks |
| Percent Change of Frequency of Voids Awakening From Sleep From Baseline to 13 Weeks | For a participant analyzed, let x0 = average number of voids awakening from sleep per 24 hours in first 72 hours of baseline diary, x1 = average number of voids awakening from sleep per 24 hours in first 72 hours of 13-week diary, and x = percent change of frequency of voids awakening from sleep from baseline to 13 weeks. Then x = 100 * (x1 - x0) / x0. For example, a participant with an average of 2 voids awakening from sleep per 24 hours in the first 72 hours of the baseline diary and an average of 1 void awakening from sleep per 24 hours during the first 72 hours of the 13-week diary would have a percent change of frequency of voids awakening from sleep from baseline to 13 weeks of 100 * (1 - 2) / 2 = -50. |
| Measure | Description | Time Frame |
|---|---|---|
| Threshold at 13 Weeks | Neuromodulation pulse amplitude required to evoke paresthesia or motor response ("threshold") at 13 weeks. | 13 weeks |
| Change of Score on an Overactive Bladder Questionnaire Short-form (OAB-q SF) Symptom Bother Subscale From Baseline to 13 Weeks |
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Inclusion Criteria:
At pre-screening:
At screening:
Based on pre-therapy voiding diary:
Exclusion Criteria:
At pre-screening:
At screening:
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| Name | Affiliation | Role |
|---|---|---|
| Parminder Sethi, M.D. | Pacific Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Urology | San Ramon | California | 94583 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40029222 | Derived | Sethi PS, Peters KM. A First-In-Human Feasibility Study of a New Implantable Tibial Nerve Stimulator for Overactive Bladder Syndrome. Neuromodulation. 2025 Jul;28(5):832-839. doi: 10.1016/j.neurom.2025.01.013. Epub 2025 Mar 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change of Urinary Incontinence Frequency From Baseline to 13 Weeks | For a participant analyzed, let x0 = average number of voids with leakage per 24 hours in first 72 hours of baseline diary, x1 = average number of voids with leakage per 24 hours in first 72 hours of 13-week diary, and x = percent change of urinary incontinence frequency from baseline to 13 weeks. Then x = 100 * (x1 - x0) / x0. For example, a participant with an average of 4 voids with leakage per 24 hours in the first 72 hours of the baseline diary and 2 voids with leakage per 24 hours in the first 72 hours of the 13-week diary would have a percent change of urinary incontinence frequency from baseline to 13 weeks of 100 * (2 - 4) / 4 = -50. | Subjects who met the inclusion criterion for incontinence | Posted | Mean | Standard Deviation | percent change | Baseline to 13 weeks |
|
26 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision-site issue | Skin and subcutaneous tissue disorders | Systematic Assessment | Three (3) subjects experienced redness at the site (cause undetermined) and of these, 2 resolved with treatment, and 1 resolved spontaneously. One (1) had a positive bacterial culture at the site, which resolved with treatment. |
Clinical feasibility study with single-arm design, single investigator, and small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Jacobson | Nine Continents Medical, Inc. | 6128105810 | PETERJACOBSON777@YAHOO.COM |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2020 | Mar 17, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 21, 2020 | Mar 17, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Baseline to 13 weeks |
| Percent Change of Frequency of Voids With Urgency From Baseline to 13 Weeks | For a participant analyzed, let x0 = average number of voids with urgency per 24 hours in first 72 hours of baseline diary, x1 = average number of voids with urgency per 24 hours in first 72 hours of 13-week diary, and x = percent change of frequency of voids with urgency from baseline to 13 weeks, where "voids with urgency" means voids self-reported with some or severe urgency, or leakage. Then x = 100 * (x1 - x0) / x0. For example, a participant with an average of 8 voids with urgency per 24 hours in the first 72 hours of the baseline diary and an average of 5 voids with urgency per 24 hours during the first 72 hours of the 13-week diary would have a percent change of frequency of voids with urgency from baseline to 13 weeks of 100 * (5 - 8) / 8 = -37.5 | Baseline to 13 weeks |
The overactive bladder questionnaire short-form (OAB-q SF) symptom bother subscale ranges from 0 to 100, and higher symptom bother scores indicate greater symptom bother ( worse outcome). For a participant analyzed, let x0 = symptom bother score at baseline, x1 = symptom bother score at 13 weeks, and x = x0 - x1. For example, a participant with a symptom bother score of 60 at baseline and a symptom bother score of 20 at 13 weeks would have a change of score on the overactive bladder questionnaire short-form (OAB-q SF) symptom bother subscale from baseline to 13 weeks of -40. |
| Baseline to 13 weeks |
| Score on a Global Response Assessment (GRA) Scale at 13 Weeks | The global response assessment (GRA) scale ranges from 1 to 6, with 1 corresponding to "markedly worse" and 6 corresponding to "markedly better", so that higher scores represent better outcomes.. | 13 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Met inclusion criterion for incontinence, based on pre-therapy diary | Count of Participants | Participants |
|
| Met inclusion criterion for frequency, based on pre-therapy diary | Count of Participants | Participants |
|
| Met inclusion criterion for nocturia, based on pre-therapy diary | Count of Participants | Participants |
|
| Met inclusion criterion for urgency, based on pre-therapy diary | Count of Participants | Participants |
|
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.
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.
|
|
| Primary | Percent Change of Excess Voiding Frequency During Waking Hours From Baseline to 13 Weeks | For a participant analyzed, let x0 = average number of voids during waking hours per 24 hours in first 72 hours of baseline diary, x1 = average number of voids during waking hours per 24 hours in first 72 hours of 13-week diary, and x = percent change of excess voiding frequency during waking hours from baseline to 13 weeks, where "excess" means voids during waking hours exceeding 7 per 24 hours. Then x = 100 * (x1 - x0) / (x0 - 7). For example, a participant with an average of 16 voids during waking hours per 24 hours in the first 72 hours of the baseline diary and an average of 10 voids during waking hours per 24 hours during the first 72 hours of the 13-week diary would have a percent change of excess voiding frequency during waking hours from baseline to 13 weeks of 100 * (10 - 16) / (16 - 7) = -67. | Subjects meeting inclusion criterion for frequency at baseline | Posted | Mean | Standard Deviation | percent change | Baseline to 13 weeks |
|
|
|
| Primary | Percent Change of Frequency of Voids Awakening From Sleep From Baseline to 13 Weeks | For a participant analyzed, let x0 = average number of voids awakening from sleep per 24 hours in first 72 hours of baseline diary, x1 = average number of voids awakening from sleep per 24 hours in first 72 hours of 13-week diary, and x = percent change of frequency of voids awakening from sleep from baseline to 13 weeks. Then x = 100 * (x1 - x0) / x0. For example, a participant with an average of 2 voids awakening from sleep per 24 hours in the first 72 hours of the baseline diary and an average of 1 void awakening from sleep per 24 hours during the first 72 hours of the 13-week diary would have a percent change of frequency of voids awakening from sleep from baseline to 13 weeks of 100 * (1 - 2) / 2 = -50. | Subjects meeting inclusion criterion for nocturia at baseline | Posted | Mean | Standard Deviation | percent change | Baseline to 13 weeks |
|
|
|
| Primary | Percent Change of Frequency of Voids With Urgency From Baseline to 13 Weeks | For a participant analyzed, let x0 = average number of voids with urgency per 24 hours in first 72 hours of baseline diary, x1 = average number of voids with urgency per 24 hours in first 72 hours of 13-week diary, and x = percent change of frequency of voids with urgency from baseline to 13 weeks, where "voids with urgency" means voids self-reported with some or severe urgency, or leakage. Then x = 100 * (x1 - x0) / x0. For example, a participant with an average of 8 voids with urgency per 24 hours in the first 72 hours of the baseline diary and an average of 5 voids with urgency per 24 hours during the first 72 hours of the 13-week diary would have a percent change of frequency of voids with urgency from baseline to 13 weeks of 100 * (5 - 8) / 8 = -37.5 | Subjects meeting inclusion criterion for urgency at baseline | Posted | Mean | Standard Deviation | percent change | Baseline to 13 weeks |
|
|
|
| Secondary | Threshold at 13 Weeks | Neuromodulation pulse amplitude required to evoke paresthesia or motor response ("threshold") at 13 weeks. | Posted | Mean | Standard Deviation | Volts | 13 weeks |
|
|
|
| Secondary | Change of Score on an Overactive Bladder Questionnaire Short-form (OAB-q SF) Symptom Bother Subscale From Baseline to 13 Weeks | The overactive bladder questionnaire short-form (OAB-q SF) symptom bother subscale ranges from 0 to 100, and higher symptom bother scores indicate greater symptom bother ( worse outcome). For a participant analyzed, let x0 = symptom bother score at baseline, x1 = symptom bother score at 13 weeks, and x = x0 - x1. For example, a participant with a symptom bother score of 60 at baseline and a symptom bother score of 20 at 13 weeks would have a change of score on the overactive bladder questionnaire short-form (OAB-q SF) symptom bother subscale from baseline to 13 weeks of -40. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to 13 weeks |
|
|
|
| Secondary | Score on a Global Response Assessment (GRA) Scale at 13 Weeks | The global response assessment (GRA) scale ranges from 1 to 6, with 1 corresponding to "markedly worse" and 6 corresponding to "markedly better", so that higher scores represent better outcomes.. | Posted | Mean | Standard Deviation | Score on a scale | 13 weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 8 |
| 10 |
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| Urinary tract infection | Renal and urinary disorders | Systematic Assessment | Not device or procedure related. |
|
| Previously-planned surgery for unrelated issue | Surgical and medical procedures | Systematic Assessment | One (1) subject had surgery for torn tendon and/or ligaments in right shoulder. One (1) had total replacement of right knee. |
|
| Unconfirmed report that implant "stopped working" | Product Issues | Systematic Assessment | Subject's impression could not be confirmed. Device check showed normal operation. Subject completed a voiding diary at 13 weeks, which showed responder status. |
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For this clinical feasibility study, the investigator agrees to maintain confidentiality and refrain from publication without the sponsor's prior written approval.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |