Transcutaneous Tibial Nerve Stimulation: the ZIDA Device Equivalence

March 21, 2021 updated by: Exodus Innovations

Transcutaneous Tibial Nerve Stimulation: the ZIDA Device

Tibial nerve stimulation (TNS) has been shown to be an effective alternative for the management of the overactive bladder (OAB). Transcutaneous Tibial Nerve Stimulation (TTNS) uses a series of regular electrical pulses to stimulate the tibial nerve. Numerous studies have positively shown the efficacy of this treatment. These studies have included multicentric, double-blind, randomized sham-controlled study of patients with idiopathic OAB. , . In 2013 the British National Institute for Health and Care Excellence (NICE) guidance has added TTNS as a second-line option for the management of female urinary incontinence , .

In reality, the vast majority of patients treated using tibial nerve receive treatment percutaneously (PTNS) by inserting a needle into their lower leg. PTNS requires 12 visits to a physician's office and a painful treatment experience. From a physician's perspective PTNS is resource intensive in terms of time, financial and staff commitments. As a result, PTNS is often not a feasible option from the point of view of health care delivery. Moreover, the treatment may not be an option for patients whose schedule or ability to travel is limited. These issues are exacerbated for those with disabilities requiring special transport arrangements and who have trouble committing to 12 expensive and long trips to receive treatment. Additionally, 8% of patients who undergo PTNS complain of adverse effects which include pain, bruising, tingling or bleeding at the insertion site of the 34-gauge needle. As a direct result of these limitations long-term follow up studies of patients undergoing PTNS treatment show poor compliance to PTNS over time .

Non-invasive, homecare TTNS devices such as the ZIDA Wearable Neuromodulation System are on the cusp of achieving regulatory clearance. TTNS, stimulates transcutaneously at a home-based setting and at least one study has explored the efficacy of this treatment method . Early results have demonstrated improvements in OAB symptom scores and urodynamic parameters . So far, these studies have employed standard commercial TENS devices (transcutaneous electrical nerve stimulation). These studies have used a variety of treatment frequencies to stimulate the tibial nerve at frequencies between 10 to 40 Hz, patient have been advised which pre-determined stimulation settings can be used for home care treatment. Commercial TENS devices limit mobility of patients during the time that the nerve is being stimulated.

Study Overview

Detailed Description

The ZIDA device uses a series of regular electrical pulses to stimulate the tibial nerve for the management of overactive bladder by a patient in the home setting. The most common potential risk and complication associated with the ZIDA device are discomfort and pain (including throbbing pain) at, or near the stimulation site, including the patient's lower leg and foot; Redness/inflammation at, or near, the stimulation site; Numbness of toes. This study is designed to exclude those subjects who may be at risk for known and unknown complications. No other complications have been reported and there are no new or other expected complications or risks expected in this clinical study, making the safety profile of the ZIDA no greater than that of other tibial nerve stimulator products that are commercially used for treatment of overactive bladder.

As mentioned above, the ZIDA device has a low potential for risks and complications. Therefore, the study Sponsor and Principle Investigator have determined that through their participation in this clinical study, the study subjects will be exposed to no new risks compared to the risks of devices currently available for similar intended uses. Specifically, the proposed study of ZIDA meets the definition of an NSR (nonsignificant risk) study for the following reasons:

  • ZIDA is NOT intended as an implant
  • ZIDA is NOT purported or represented to be for use supporting or sustaining human life
  • ZIDA does NOT present a potential for serious risk to the health, safety or welfare of a subject
  • ZIDA has a very low safety risk profile.
  • The study will be conducted by investigational centre and investigators with experience and expertise and sufficient staff to provide quality care to subjects requiring treatment of an overactive bladder.
  • The study was designed to mitigate any potential unknown risk through the eligibility criteria, subject selection and training on the ZIDA device.

As addressed above, the ZIDA device does NOT otherwise present a potential for serious risk to the health, safety or welfare of a subject and meets the definition of a NSR study.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Coral Gables, Florida, United States, 33133
        • Miami Medical Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is willing and able to give informed consent for participation in the trial.
  • Subject is Male or Female, aged 21 years or older.
  • Subject has been diagnosed with overactive bladder (OAB).

    o Subject eligibility is based on meeting the criteria for an OAB, defined by the International Continence Society as an average urinary frequency: ≥8 voids and ≥1 urgency episode (with or without incontinence) per 24 hours .

  • Subject has clinically acceptable laboratory results within 30 days of enrolment Urinalysis: Dipstick

Acceptable results:

  • pH - results not relevant
  • Specific gravity - results not relevant
  • Glucose - results not relevant
  • Ketones - results not relevant
  • Nitrites - normal
  • Leukocyte esterase (leukocytes) - normal
  • Bilirubin - results not relevant
  • Urobilirubin - results not relevant
  • Blood - normal
  • Protein - results not relevant If the urinanalysis is normal no further laboratory studies are indicated. If the urinanalysis abnormal then patient should not be admitted into trial.
  • Subject has a score of 60 or higher on the Incontinence impact questionnaire-OAB-q Short Form, 4-week recall.
  • In the Investigator's opinion, Subject is able and willing to comply with all trial requirements, including the use of the investigational device in a home setting.
  • Subject is willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.

Exclusion Criteria:

  • The Subject may not enter the trial if ANY of the following apply:

    • Female Subject who is pregnant, lactating or planning pregnancy during the course of the trial.
    • Administration of intravesical injection of botulinum toxin within 36 months of study enrolment.
    • A treatment within the previous year of neuromodulation (TNS or sacral neuromodulation) for OAB.
    • Subject with sensory loss in the gaiter region (cutaneous sensation to nociception was assessed in the lower limb).
    • Presence of urinary tract infection or any other documented lower urinary tract (LUT) pathology.
    • Subject with pacemakers or implantable defibrillators
    • Subject who have participated in another research trial involving an investigational product in the past 12 weeks.
    • Subjects with neurological disease
    • Subject on antimuscarinic medications for OAB who have not gone through a 2-week run-in washout period during which time medications were discontinued.
    • Subject is a prisoner or is mentally incompetent.
    • Subject has inflamed, infected or otherwise compromised skin in the area of treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Treatment
Active Zida device to be delivered for use by patient
Transcutaneous Tibial Nerve Stimulation
Sham Comparator: Sham Treatment
Identical Sham device to be delivered for use by patient
Transcutaneous Tibial Nerve Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success rate of Zida device in treating OAB
Time Frame: 12 weeks
The primary efficacy endpoint will be analysed for the FAS population. The primary endpoint is the difference in treatment success between the Zida arm and the sham arm. Treatment success is defined as at least a 30% reduction in the frequency of daytime, night time, or moderate/severe/incontinence voids from baseline to week 12 from an average of the three day ICIQ bladder diary. A chi square test will be used to compare the clinical success rates between the treatment arms.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Zida device on patient quality of life as measured by quality of life questionnaire.
Time Frame: 12 weeks
This secondary endpoint is the difference in change in QOL score from baseline to week 12 between the Zida arm and the sham arm.
12 weeks
Frequency of daily voids
Time Frame: 12 weeks
This secondary efficacy endpoint is a comparison the change from baseline to week 12 in frequency of daily (daytime and nighttime) voids in the ZIDA arm from an average of the three day ICIQ bladder diary to the reported frequency.
12 weeks
Frequency of moderate/severe/incontinence voids
Time Frame: 12 weeks
This secondary efficacy endpoint is a comparison the change from baseline to week 12 in frequency of moderate/severe/incontinence voids in the ZIDA arm from an average of the three day ICIQ bladder diary to the reported frequency.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 9, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 21, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overactive Bladder

3
Subscribe