Overactive BladderNCT04470765
Transcutaneous Tibial Nerve Stimulation: the ZIDA Device Equivalence
A study testing Zida in people with Overactive Bladder and Urge Incontinence, run by Exodus Innovations at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder, Urge Incontinence, Urinary Incontinence
- What is being tested?
- Zida
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 19Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami Medical Consultants
Coral Gables, Florida, 33133
About this study
Official title: 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.
Read the 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.
- Conditions
- Overactive Bladder, Urge Incontinence, Urinary Incontinence, Urinary Frequency More Than Once at Night
- Being tested
- Zida
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urinary Incontinence, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZidaDevice
Transcutaneous Tibial Nerve Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Active Zida device to be delivered for use by patient Receives: Device: Zida |
| Sham Treatment | Sham comparator | Identical Sham device to be delivered for use by patient Receives: Device: Zida |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start15 Sep 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exodus Innovations
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470765
- Sponsor's protocol ID
- 2020-9050 v1.0.6
- Status last verified
- Mar 2021
- First submitted
- 7 Jul 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35622269
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Tibial Nerve Stimulation: the ZIDA Device
- ClinicalTrials.gov ID
- NCT04470765
- Acronym / sponsor ID
- 2020-9050 v1.0.6
- Conditions
- Overactive Bladder, Urge Incontinence, Urinary Incontinence, Urinary Frequency More Than Once at Night
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Exodus InnovationsIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Device: ZidaActive Zida device to be delivered for use by patient |
| Sham Treatment | Sham comparator | Device: ZidaIdentical Sham device to be delivered for use by patient |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (12 listed)
- The Subject may not enter the trial if ANY of the following apply:
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 |
|---|---|---|
| ZidaTranscutaneous Tibial Nerve Stimulation | Device | Active Treatment, Sham Treatment |
Primary outcome
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.
3 secondary outcomes
Impact of Zida device on patient quality of life as measured by quality of life questionnaire.
Time frame: 12 weeks
Frequency of daily voids
Time frame: 12 weeks
Frequency of moderate/severe/incontinence voids
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Derived from this study: PubMed 35622269Cava 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zida in people with Overactive Bladder and Urge Incontinence, run by Exodus Innovations 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 19 inclusion and 12 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 23 Mar 2021. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical success rate of Zida device in treating OAB (time frame: 12 weeks). 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 NCT04470765, 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 23 Mar 2021.