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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
ZIDA Control Sock
DeviceThe ZIDA Control Sock is an FDA-cleared, noninvasive wearable neuromodulation device designed for home use. The device delivers low-level electrical stimulation near the ankle to stimulate peripheral nerves involved in bladder control. In this study, the device is used as an adjunct to usual pharmacologic care.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: ZIDA Add-On TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean change in daily urgency urinary incontinence (UUI) episodes (3-day bladder diary)
The primary outcome is the mean change in total daily urgency urinary incontinence (UUI) episodes after addition of ZIDA therapy to stable pharmacologic treatment for overactive bladder. Changes will be evaluated from baseline to Weeks 1, 4, and 8 for descriptive interim analyses and to Week 12 for final analysis. Interim analyses will not be used for early stopping or hypothesis testing.
Time frame
From baseline to at the end of treatment at 12 weeksSecondary outcomes
1
Mean change in daily urgency episodes (3-day bladder diary)
Change in the average number of daily urgency episodes recorded in a 3-day bladder diary at Baseline and Week 12.
Time frame
Baseline to end of treatment at 12 weeks2
Mean change in daily urinary frequency (3-day bladder diary)
Change in the average number of daily voids from a 3-day bladder diary collected at Baseline and Week 12.
Time frame
Baseline to end of treatment at 12 weeks3
Change in OAB-Q Short Form (1-Week Recall) Total Score
Change in total score on the OAB-Q Short Form (1-Week Recall), a validated 19-item questionnaire assessing OAB symptom bother and quality of life. Higher scores indicate worse symptoms.
Time frame
Baseline to end of treatment at 12 weeks4
Patient Global Impression of Improvement (PGI-I)
Participant-reported global impression of improvement rated on a 7-point scale (1 = very much improved to 7 = very much worse).
Time frame
Baseline to end of treatment at 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
Collaborator
Medtronic
Collaborator
Source ClinicalTrials.gov