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New treatment option for Overactive Bladder
Official title Add-On ZIDA Sock Therapy for Overactive Bladder
ClinicalTrials.gov ID: NCT07432659
What this study is testing
- What it's testing
- Many people with overactive bladder (OAB) continue to experience symptoms despite pharmacologic treatment. This study evaluates the use of the ZIDA Control Sock, an FDA-cleared, noninvasive wearable device that delivers mild electrical stimulation near the ankle, as an adjunct to usual care.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years.
- Diagnosis of OAB-wet (OAB with urgency urinary incontinence) documented by clinical diagnosis
- Baseline ≥1 UUI episode/day averaged over a 3-day diary
- Is on a stable pharmacotherapy for OAB for ≥4 weeks, with intent to remain on their medication regimen for the duration of this study
- Has the ability to complete bladder diaries, questionnaires, and attend follow-up visits
You likely can't join if
- Neurologic disease affecting bladder function, including multiple sclerosis, spinal cord injury, Parkinson's disease, or other neurogenic bladder...
- Significant pelvic organ prolapses or other pelvic pathology likely to interfere with bladder emptying, neuromodulation how well it works, or study...
- Active urinary tract infection or unexplained hematuria at screening
- Clinically significant post-void residual volume above threshold (e.g., \>100 mL)
- History of, failure of, or current use of neuromodulation therapies, including percutaneous or transcutaneous tibial nerve stimulation, sacral...
- Intravesical botulinum toxin injections less than 9 months prior to entry into the study
See the full eligibility criteria
- Age ≥18 years.
- Diagnosis of OAB-wet (OAB with urgency urinary incontinence) documented by clinical diagnosis
- Baseline ≥1 UUI episode/day averaged over a 3-day diary
- Is on a stable pharmacotherapy for OAB for ≥4 weeks, with intent to remain on their medication regimen for the duration of this study
- Has the ability to complete bladder diaries, questionnaires, and attend follow-up visits
- Cognitively intact adult and able to understand study procedures and provide informed consent independently
- Neurologic disease affecting bladder function, including multiple sclerosis, spinal cord injury, Parkinson's disease, or other neurogenic bladder conditions.
- Significant pelvic organ prolapses or other pelvic pathology likely to interfere with bladder emptying, neuromodulation how well it works, or study assessments in the opinion of the investigator
- Active urinary tract infection or unexplained hematuria at screening
- Clinically significant post-void residual volume above threshold (e.g., \>100 mL)
- History of, failure of, or current use of neuromodulation therapies, including percutaneous or transcutaneous tibial nerve stimulation, sacral neuromodulation (InterStim), implantable tibial devices (eCoin)
- Intravesical botulinum toxin injections less than 9 months prior to entry into the study
- Pregnancy or plans to become pregnant during study participation, and women of childbearing age not using contraception. A urine pregnancy test will be performed for women of childbearing potential to confirm...
- Contraindications to electrical stimulation (cardiac pacemaker or implanted defibrillator without physician clearance, unhealed wounds near stimulation site, metal implants in the ankle region)
- Significant uncontrolled medical conditions, such as unstable cardiac disease, poorly controlled diabetes mellitus, severe peripheral edema, or severe peripheral neuropathy that may affect lower-limb sensation or...
- Pelvic malignancy or prior pelvic radiotherapy.
- Current participation in another investigational drug or device trial, or use of an investigational therapy within the last 30 days
- Known hypersensitivity or intolerance to materials used in the ZIDA device (electrode adhesives, conductive gels)
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.