Add-On ZIDA Sock Therapy for Overactive Bladder
ConditionOveractive Bladder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
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. Adults with OAB-wet who remain symptomatic on stable medication will use the device at home once weekly for 12 weeks while continuing their prescribed therapy. The study collects clinical, patient-reported, and safety information during adjunctive device use.
Eligibility criteria
Qualifiers
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
Disqualifiers
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 efficacy, 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)
Trial design
Treatments tested in this trial
- ZIDA Control Sock
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Medical University of South Carolina
Lead sponsor
Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
Collaborator
Medtronic
Collaborator
Source ClinicalTrials.gov