Status:
COMPLETED
Transcutaneous Tibial Nerve Stimulation: the ZIDA Device Equivalence
Lead Sponsor:
Exodus Innovations
Conditions:
Overactive Bladder
Urge Incontinence
Eligibility:
All Genders
21+ years
Phase:
NA
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...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04470765
Start Date
September 15 2020
End Date
December 31 2020
Last Update
March 23 2021
Active Locations (1)
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1
Miami Medical Consultants
Coral Gables, Florida, United States, 33133