Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04470765 |
Other study ID # |
2020-9050 v1.0.6 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 15, 2020 |
Est. completion date |
December 31, 2020 |
Study information
Verified date |
March 2021 |
Source |
Exodus Innovations |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.