Transcutaneous Tibial Nerve Stimulation: the ZIDA Device Equivalence
Primary Purpose
Overactive Bladder, Urge Incontinence, Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zida
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
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.
Sites / Locations
- Miami Medical Consultants
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active Treatment
Sham Treatment
Arm Description
Active Zida device to be delivered for use by patient
Identical Sham device to be delivered for use by patient
Outcomes
Primary Outcome Measures
Clinical success rate of Zida device in treating OAB
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.
Secondary Outcome Measures
Impact of Zida device on patient quality of life as measured by quality of life questionnaire.
This secondary endpoint is the difference in change in QOL score from baseline to week 12 between the Zida arm and the sham arm.
Frequency of daily voids
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.
Frequency of moderate/severe/incontinence voids
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04470765
Brief Title
Transcutaneous Tibial Nerve Stimulation: the ZIDA Device Equivalence
Official Title
Transcutaneous Tibial Nerve Stimulation: the ZIDA Device
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Exodus Innovations
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
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urge Incontinence, Urinary Incontinence, Urinary Frequency More Than Once at Night
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a prospective, randomized, single-blind, placebo-controlled study of 50 subjects divided into two groups, with one group having the active ZIDA device treatment once weekly at home, and one group having a sham ZIDA device (non-treatment) once weekly at home, for a duration of 12 weeks for both groups. Subjects will be called by a research member weekly to report their weekly treatment and any complications during the 12-week treatment period. A phone call assessment will be conducted during week-6 period. Subjects will complete a final phone-call assessment at the end of the week-12 period.
This clinical investigation is being conducted in accordance with 21 CFR Parts 50, 54, 56, and abbreviated 21 CFR 812 regulations, International Conference on Harmonization Good Clinical Practice (ICH GCPs), applicable local regulations and Institutional Review Board (IRB) requirements.
Masking
ParticipantCare ProviderInvestigator
Masking Description
A third party will be assigned to label the devices prior to distribution to the study center. The 3rd party will maintain blinding of the device labelling/ assignment codes until the trial completion.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment
Arm Type
Active Comparator
Arm Description
Active Zida device to be delivered for use by patient
Arm Title
Sham Treatment
Arm Type
Sham Comparator
Arm Description
Identical Sham device to be delivered for use by patient
Intervention Type
Device
Intervention Name(s)
Zida
Intervention Description
Transcutaneous Tibial Nerve Stimulation
Primary Outcome Measure Information:
Title
Clinical success rate of Zida device in treating OAB
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Impact of Zida device on patient quality of life as measured by quality of life questionnaire.
Description
This secondary endpoint is the difference in change in QOL score from baseline to week 12 between the Zida arm and the sham arm.
Time Frame
12 weeks
Title
Frequency of daily voids
Description
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.
Time Frame
12 weeks
Title
Frequency of moderate/severe/incontinence voids
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Miami Medical Consultants
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35622269
Citation
Cava R, Orlin Y. Home-based transcutaneous tibial nerve stimulation for overactive bladder syndrome: a randomized, controlled study. Int Urol Nephrol. 2022 Aug;54(8):1825-1835. doi: 10.1007/s11255-022-03235-z. Epub 2022 May 27.
Results Reference
derived
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Transcutaneous Tibial Nerve Stimulation: the ZIDA Device Equivalence
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