Transcutaneous Tibial Nerve Stimulation: the ZIDA Device Equivalence

NCT04470765 | Completed FDA Device

• 1 other identifier: 2020-9050 v1.0.6
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Urge Incontinence; Urinary Incontinence; Urinary Frequency More Than Once at Night

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (3)

• Impact of Zida device on patient quality of life as measured by quality of life questionnaire.

  12 weeks

• Frequency of daily voids

  12 weeks

• Frequency of moderate/severe/incontinence voids

  12 weeks

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

Active Zida device to be delivered for use by patient

Device: Zida

Sham Treatment

SHAM COMPARATOR

Identical Sham device to be delivered for use by patient

Device: Zida

Interventions

Zida DEVICE

Transcutaneous Tibial Nerve Stimulation

Active Treatment; Sham Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Exodus Innovations: lead

Study Sites (1)

Miami Medical Consultants

Coral Gables, Florida, 33133, United States

Location

Related Publications (1)

• 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.

  PMID: 35622269 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Incontinence; Nocturia

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 14, 2020
• Study Start: September 15, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)