Overactive BladderNCT04115228

Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

A study testing Implantation and neuromodulation therapy in people with Overactive Bladder, run by Nine Continents Medical, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Overactive Bladder
What is being tested?: Implantation and neuromodulation therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 9 Oct 2019to 3 Mar 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 16Show fewer

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.

Who cannot join

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;

Show all 40Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pacific Urology
San Ramon, California, 94583

Other trials in United States

About this study

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.

Conditions: Overactive Bladder
Being tested: Implantation and neuromodulation therapy
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.

Implantation and neuromodulation therapyDevice
Also called Nine Continents Medical ITNS model 9C-680
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.

Study groups in NCT04115228
Study group	Role	What they receive
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. Receives: Device: Implantation and neuromodulation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline to 13 weeks

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 20193 Mar 2021

First posted3 Oct 2019
Study start9 Oct 2019
Primary completion31 Jan 2021
Study completion3 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04115228
Sponsor's protocol ID: ITNS-01
Other IDs: R44DK121578
Status last verified: Mar 2022
First submitted: 1 Oct 2019
Last updated: 12 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 40029222

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
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Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
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All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
ClinicalTrials.gov ID: NCT04115228
Acronym / sponsor ID: ITNS-01
Conditions: Overactive Bladder
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Nine Continents Medical, Inc.Industry (pharma, biotech, devices)
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 9 Oct 2019 (actual)
Primary completion: 31 Jan 2021 (actual)
Study completion: 3 Mar 2021 (actual)
First posted: 3 Oct 2019 (actual)
Results: Posted 12 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study device	Experimental	Device: Implantation and neuromodulation therapySubjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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.

Key exclusion criteria (40 listed)

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;

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
Implantation and neuromodulation therapyAlso: Nine Continents Medical ITNS model 9C-680The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.	Device	Study device

Primary outcome

Percent Change of Urinary Incontinence Frequency From Baseline to 13 Weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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

3 secondary outcomes

Threshold at 13 Weeks
Time frame: 13 weeks
Change of Score on an Overactive Bladder Questionnaire Short-form (OAB-q SF) Symptom Bother Subscale From Baseline to 13 Weeks
Time frame: Baseline to 13 weeks
Score on a Global Response Assessment (GRA) Scale at 13 Weeks
Time frame: 13 weeks

Results and safety

Results posted to the registry on 12 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Device	10	10

Primary outcome: Percent Change of Urinary Incontinence Frequency From Baseline to 13 Weeks

Time frame: Baseline to 13 weeks. Mean (Standard Deviation). Unit: percent change

Measure	Study Device n = 7
Value	-89 (14)

Population analysed: Subjects who met the inclusion criterion for incontinence

Primary outcome: Percent Change of Excess Voiding Frequency During Waking Hours From Baseline to 13 Weeks

Time frame: Baseline to 13 weeks. Mean (Standard Deviation). Unit: percent change

Measure	Study Device n = 2
Value	-90 (33)

Population analysed: Subjects meeting inclusion criterion for frequency at baseline

Primary outcome: Percent Change of Frequency of Voids Awakening From Sleep From Baseline to 13 Weeks

Time frame: Baseline to 13 weeks. Mean (Standard Deviation). Unit: percent change

Measure	Study Device n = 7
Value	-30 (25)

Population analysed: Subjects meeting inclusion criterion for nocturia at baseline

Primary outcome: Percent Change of Frequency of Voids With Urgency From Baseline to 13 Weeks

Time frame: Baseline to 13 weeks. Mean (Standard Deviation). Unit: percent change

Measure	Study Device n = 10
Value	-69 (23)

Population analysed: Subjects meeting inclusion criterion for urgency at baseline

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 26 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Device	0 of 10 (0%)	8 of 10 (80%)	0 of 10

Limitations and caveats (from the sponsor): Clinical feasibility study with single-arm design, single investigator, and small sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40029222Sethi 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.
Individual participant dataSharing planned: No

Related trials for Overactive Bladder

Not yet recruitingPhase 4
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APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
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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.

Parminder Sethi, M.D. principal investigator

Pacific Urology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Implantation and neuromodulation therapy in people with Overactive Bladder, run by Nine Continents Medical, Inc. at 1 site 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?

The sponsor lists 16 inclusion and 40 exclusion criteria. 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 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 12 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change of Urinary Incontinence Frequency From Baseline to 13 Weeks (time frame: Baseline to 13 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04115228, which also lists 1 linked publication.

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 12 Apr 2022.