ZIDA Sock for Overactive Bladder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to assist people with overactive bladder (OAB) who continue to experience symptoms despite medication. It examines the ZIDA Control Sock, a wearable device that sends gentle electrical signals near the ankle to determine if it helps reduce bladder issues when used alongside usual treatments. The trial targets adults with OAB-wet, characterized by sudden urges to urinate that lead to leaks, who have been on stable medication for at least four weeks. Participants will use the sock once a week at home for 12 weeks while continuing their regular medication. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for OAB.
Will I have to stop taking my current medications?
No, you will not have to stop taking your current medications. The trial requires participants to continue their prescribed therapy while using the ZIDA Control Sock.
What prior data suggests that the ZIDA Control Sock is safe for use in overactive bladder patients?
Research has shown that the ZIDA Control Sock is safe for individuals with overactive bladder (OAB). Many studies and sources support this finding. The FDA has approved the ZIDA device, confirming it meets safety standards for treating incontinence and OAB. Studies describe the device as safe and effective in reducing symptoms such as urgent and frequent urination, both day and night. Additionally, the device is noninvasive, requiring no surgery or internal procedures, which often makes treatments easier to manage. No major negative effects have been reported so far, suggesting that users tolerate the ZIDA Sock well.12345
Why are researchers excited about this trial?
The ZIDA Control Sock is unique because it offers a non-drug approach to managing overactive bladder by incorporating wearable technology. Unlike standard treatments, which include medications like anticholinergics or beta-3 adrenergic agonists, this sock is used as an add-on therapy, potentially enhancing the effects of existing medications. Researchers are excited about this treatment because it provides a novel, convenient delivery method that may improve patient compliance and comfort. Additionally, the sock is designed for home use, which could make it an accessible option for many individuals looking to manage their symptoms more effectively.
What evidence suggests that the ZIDA Control Sock is effective for overactive bladder?
Studies have shown that the ZIDA Control Sock can effectively help people with overactive bladder (OAB). Research indicates that using the ZIDA sock can significantly reduce sudden urges to urinate, with some studies reporting at least a 50% decrease in these urgent episodes and a 30% reduction in accidents over a 24-hour period. The sock delivers gentle electrical pulses near the ankle, calming the nerves that can cause bladder control problems. Feedback from previous trials also shows improvements in quality of life when using the sock. In this trial, participants will continue their usual pharmacologic treatment for OAB and use the ZIDA Control Sock as an add-on therapy. Overall, the ZIDA Control Sock has proven to be a promising additional treatment for those still experiencing OAB symptoms despite medication.16789
Who Is on the Research Team?
Connie Wang, MD
Principal Investigator
Medical University of South Carolina
Eric Rovner, MD
Principal Investigator
Medical University of South Carolina
Are You a Good Fit for This Trial?
This trial is for adults 18 or older with overactive bladder and daily urine leakage, who are still having symptoms despite being on stable medication for at least 4 weeks. Participants must be able to understand instructions, fill out diaries and questionnaires, and attend follow-up visits.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the ZIDA Control Sock at home once weekly for 12 weeks while continuing their prescribed pharmacologic therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ZIDA Control Sock
Trial Overview
The study tests the ZIDA Control Sock—a wearable device that gives mild electrical stimulation near the ankle—used once a week at home for 12 weeks in addition to usual OAB medications. The goal is to see if it helps reduce symptoms.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will continue usual pharmacologic treatment for overactive bladder and will use the ZIDA Control Sock at home once weekly over the study treatment period. Device use is evaluated as an adjunct to standard care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
Collaborator
Medtronic
Industry Sponsor
Geoff Martha
Medtronic
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Richard Kuntz
Medtronic
Chief Medical Officer since 2023
MD, MSc
Citations
Home-based transcutaneous tibial nerve stimulation for ...
Treatment success was defined as at least a 50% reduction in urgency voids with or without incontinence or at least a 30% reduction in 24-h ...
Version Date 01/06/2026 Page 1 of 12
ZIDA Control Sock as an add-on therapy for patients with overactive bladder (OAB) and urgency urinary incontinence (UUI) who are already on ...
Home-based transcutaneous tibial nerve stimulation for ... - PMC
TPTNS using the ZIDA home-based stimulation device offers a safe and effective treatment for patients with OAB syndrome and improves QOL.
4.
researchportal.hw.ac.uk
researchportal.hw.ac.uk/files/145666232/Smart_Wearable_TENS_Device_for_Home-based_Overactive_Bladder_Management.pdfSmart Wearable TENS Device for Home-based Overactive ...
Sánchez, “Patient-reported outcomes in the setting of a randomized control trial on the efficacy of transcutaneous stimulation of the posterior ...
Add-On ZIDA Sock Therapy for Overactive Bladder
This study evaluates the use of the ZIDA Control Sock, an FDA-cleared, noninvasive wearable device that delivers mild electrical stimulation ...
Use Zida Control Sock - Live Zida
The Zida Control Sock is completely safe and has been approved by the FDA as an effective treatment for incontinence and overactive bladder. The device should ...
March 19, 2021 Exodus Innovations Cherita James ...
Both the ZIDA System and the Urgent PC have similar intended use: to treat patients with Overactive. Bladder (OAB) and associated symptoms of ...
Clinical Data - Live Zida
In summary, the ZIDA device is safe and effective in reducing urinary incontinence, urinary urgency, and total urinary frequency of daytime and nighttime voids ...
Zida Control Sock - Live Zida
The Zida control sock is completely safe and has been approved by the FDA as an effective treatment for incontinence and over-active bladder. The device should ...
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