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Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implantation and neuromodulation therapy
Sponsored by
Nine Continents Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

At pre-screening:

  • Age 18 years or older;
  • Documented diagnosis of overactive bladder;
  • Documented failed behavioral intervention and/or physical therapy;
  • Documented failed first drug for overactive bladder; and
  • Documented failed second drug for overactive bladder.

At screening:

  • Life expectancy of at least one year;
  • Capable of tolerating the implantation procedure;
  • Ambulatory and able to use the toilet independently and without difficulty; and
  • Able to sense and tolerate posterior tibial nerve stimulation (transcutaneous test).

Based on pre-therapy voiding diary:

  • Average daily voids during waking hours ≥ 11;
  • Average daily voids interrupting sleep ≥ 2.0;
  • Average daily voids associated with urgency ≥ 4; or
  • Average daily incontinence episodes ≥ 1.

Exclusion Criteria:

At pre-screening:

  • Predominant stress incontinence;
  • For females, pelvic organ prolapse quantification (POP-Q) ≥ grade II;
  • Neurologic disease, e.g. MS, Parkinson's;
  • Abnormal upper urinary tract function;
  • Neurogenic bladder;
  • Bladder stone or tumor;
  • Body mass index (BMI) > 40;
  • Chronic pelvic pain;
  • Urinary fistula;
  • Peripheral neuropathy;
  • History of failed neuromodulation for overactive bladder;
  • Uncontrolled bleeding disorder;
  • End stage renal failure, glomerular filtration rate (GFR) < 35, or dialysis;
  • Untreated diabetes or A1C > 7;
  • Implanted pacemaker, defibrillator, or neurostimulator;
  • History of pelvic cancer within the past two years;
  • Condition requiring magnetic resonance imaging (MRI);
  • Condition requiring diathermy;
  • Metallic implant in planned site of study device;
  • For females, pregnant;
  • For females, planning to become pregnant;
  • For females, given birth in the last 6 months; or
  • For females, of child-bearing potential and not willing to practice a medically-approved method of birth control during the study.

At screening:

  • Anatomical restriction preventing device placement;
  • Skin lesions or compromised skin at the implant site;
  • For females, pelvic organ prolapse quantification (POP-Q) ≥ grade II;
  • Post-void residual > 150 cc;
  • Urinary tract mechanical obstruction due to urethral stricture;
  • Urinary tract mechanical obstruction due to bladder neck contracture;
  • In males, urinary tract mechanical obstruction due to benign prostatic hyperplasia (BPH);
  • Vesicoureteral reflux;
  • Cystoscopic abnormalities that could be malignant;
  • Current cystitis;
  • Current urethritis;
  • Gross hematuria;
  • In females, positive pregnancy test;
  • Any other medical condition with potential effect on bladder function, as assessed by investigator; or
  • Any other medical condition that could compromise the safety of the subject, as assessed by investigator.

Sites / Locations

  • Pacific Urology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study device

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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

Secondary Outcome Measures

Threshold at 13 Weeks
Neuromodulation pulse amplitude required to evoke paresthesia or motor response ("threshold") at 13 weeks.
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.
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..

Full Information

First Posted
October 1, 2019
Last Updated
March 17, 2022
Sponsor
Nine Continents Medical, Inc.
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04115228
Brief Title
Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
Official Title
Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 9, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
March 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nine Continents Medical, Inc.
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Implantation and neuromodulation therapy
Other Intervention Name(s)
Nine Continents Medical ITNS model 9C-680
Intervention Description
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 Outcome Measure Information:
Title
Percent Change of Urinary Incontinence Frequency From Baseline to 13 Weeks
Description
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.
Time Frame
Baseline to 13 weeks
Title
Percent Change of Excess Voiding Frequency During Waking Hours From Baseline to 13 Weeks
Description
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.
Time Frame
Baseline to 13 weeks
Title
Percent Change of Frequency of Voids Awakening From Sleep From Baseline to 13 Weeks
Description
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.
Time Frame
Baseline to 13 weeks
Title
Percent Change of Frequency of Voids With Urgency From Baseline to 13 Weeks
Description
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
Time Frame
Baseline to 13 weeks
Secondary Outcome Measure Information:
Title
Threshold at 13 Weeks
Description
Neuromodulation pulse amplitude required to evoke paresthesia or motor response ("threshold") at 13 weeks.
Time Frame
13 weeks
Title
Change of Score on an Overactive Bladder Questionnaire Short-form (OAB-q SF) Symptom Bother Subscale From Baseline to 13 Weeks
Description
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.
Time Frame
Baseline to 13 weeks
Title
Score on a Global Response Assessment (GRA) Scale at 13 Weeks
Description
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..
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At pre-screening: Age 18 years or older; Documented diagnosis of overactive bladder; Documented failed behavioral intervention and/or physical therapy; Documented failed first drug for overactive bladder; and Documented failed second drug for overactive bladder. At screening: Life expectancy of at least one year; Capable of tolerating the implantation procedure; Ambulatory and able to use the toilet independently and without difficulty; and Able to sense and tolerate posterior tibial nerve stimulation (transcutaneous test). Based on pre-therapy voiding diary: Average daily voids during waking hours ≥ 11; Average daily voids interrupting sleep ≥ 2.0; Average daily voids associated with urgency ≥ 4; or Average daily incontinence episodes ≥ 1. Exclusion Criteria: At pre-screening: Predominant stress incontinence; For females, pelvic organ prolapse quantification (POP-Q) ≥ grade II; Neurologic disease, e.g. MS, Parkinson's; Abnormal upper urinary tract function; Neurogenic bladder; Bladder stone or tumor; Body mass index (BMI) > 40; Chronic pelvic pain; Urinary fistula; Peripheral neuropathy; History of failed neuromodulation for overactive bladder; Uncontrolled bleeding disorder; End stage renal failure, glomerular filtration rate (GFR) < 35, or dialysis; Untreated diabetes or A1C > 7; Implanted pacemaker, defibrillator, or neurostimulator; History of pelvic cancer within the past two years; Condition requiring magnetic resonance imaging (MRI); Condition requiring diathermy; Metallic implant in planned site of study device; For females, pregnant; For females, planning to become pregnant; For females, given birth in the last 6 months; or For females, of child-bearing potential and not willing to practice a medically-approved method of birth control during the study. At screening: Anatomical restriction preventing device placement; Skin lesions or compromised skin at the implant site; For females, pelvic organ prolapse quantification (POP-Q) ≥ grade II; Post-void residual > 150 cc; Urinary tract mechanical obstruction due to urethral stricture; Urinary tract mechanical obstruction due to bladder neck contracture; In males, urinary tract mechanical obstruction due to benign prostatic hyperplasia (BPH); Vesicoureteral reflux; Cystoscopic abnormalities that could be malignant; Current cystitis; Current urethritis; Gross hematuria; In females, positive pregnancy test; Any other medical condition with potential effect on bladder function, as assessed by investigator; or Any other medical condition that could compromise the safety of the subject, as assessed by investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parminder Sethi, M.D.
Organizational Affiliation
Pacific Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Urology
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

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