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Transcutaneous Tibial Nerve Stimulation: the ZIDA Device Equivalence

NCT04470765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-03-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Zida

Transcutaneous Tibial Nerve Stimulation

Sponsors & Collaborators

  • Exodus Innovations

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04470765 on ClinicalTrials.gov