Overactive BladderNCT07432659
Add-On ZIDA Sock Therapy for Overactive Bladder
A study of Overactive Bladder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- 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
Show all 12Show fewer
- 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 non-pregnant status prior to enrollment.
- 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 response to stimulation in the opinion of the investigator
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutledge Tower at Medical University of South Carolina
Charleston, South Carolina, 29425
Louisa Keil, 843-792-2300 ext. 1840, Keill@musc.edu
Connie Wang, MD
About this study
Official title: Add-On Efficacy of Home-Based Transcutaneous Tibial Nerve Stimulation Via the ZIDA Control Sock in Adults With Overactive Bladder on Preexisting Stable Pharmacotherapy
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.
Read the detailed description
This study evaluates the use of a home-based neuromodulation device as an adjunct to standard pharmacologic therapy for overactive bladder with urgency urinary incontinence. The ZIDA Control Sock is an FDA-cleared, noninvasive wearable device that delivers low-level electrical stimulation near the ankle to stimulate peripheral nerves involved in bladder control.
The study is conducted as a prospective, single-arm clinical investigation in which participants use the device at home while continuing usual care. Device use is prescribed once weekly for 12 weeks. Study conduct includes participant training, remote support to ensure correct device use, and ongoing safety monitoring.
The study is designed to characterize changes observed during adjunctive device use, assess participant experience with home-based therapy, and evaluate device-related safety. Findings will contribute to understanding the feasibility and potential clinical role of wearable neuromodulation as an add-on treatment option in routine overactive bladder care.
- Conditions
- Overactive Bladder
- Being tested
- ZIDA Control Sock
- Keywords
- Overactive Bladder, Urgency Urinary Incontinence, Transcutaneous Tibial Nerve Stimulation, TTNS, Neuromodulation, ZIDA Control Sock
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZIDA Control SockDevice
The 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.
| Study group | Role | What they receive |
|---|---|---|
| ZIDA Add-On Therapy | Experimental | 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. Receives: Device: ZIDA Control Sock |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to at the end of treatment at 12 weeks
Secondary outcomes (6)
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.
Measured: Baseline to end of treatment at 12 weeks
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.
Measured: Baseline to end of treatment at 12 weeks
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.
Measured: Baseline to end of treatment at 12 weeks
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).
Measured: Baseline to end of treatment at 12 weeks
Device usability score (Usability & Satisfaction Survey)
Usability and satisfaction with the ZIDA device assessed using a six-item survey, including five Likert-scaled items evaluating ease of use, comfort, and clarity of instructions.
Measured: Baseline to end of treatment at 12 weeks
Participants with ≥1 device-related adverse event
Number of participants experiencing at least one device-related adverse event recorded through the Adverse Event Log during the 12-week treatment period.
Measured: Baseline to end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start17 Apr 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, Medtronic
- Responsible party
- Principal investigator, Connie Wang, Medical University of South Carolina
- Investigators
- Connie Wang, MD, Principal investigator, Medical University of South CarolinaEric Rovner, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432659
- Sponsor's protocol ID
- Pro00148326
- Status last verified
- May 2026
- First submitted
- 10 Feb 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Add-On Efficacy of Home-Based Transcutaneous Tibial Nerve Stimulation Via the ZIDA Control Sock in Adults With Overactive Bladder on Preexisting Stable Pharmacotherapy
- ClinicalTrials.gov ID
- NCT07432659
- Acronym / sponsor ID
- Pro00148326
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder, Urgency Urinary Incontinence, Transcutaneous Tibial Nerve Stimulation, TTNS, Neuromodulation, ZIDA Control Sock
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, Medtronic
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study evaluates the use of a home-based neuromodulation device as an adjunct to standard pharmacologic therapy for overactive bladder with urgency urinary incontinence. The ZIDA Control Sock is an FDA-cleared, noninvasive wearable device that delivers low-level electrical stimulation near the ankle to stimulate peripheral nerves involved in bladder control.
The study is conducted as a prospective, single-arm clinical investigation in which participants use the device at home while continuing usual care. Device use is prescribed once weekly for 12 weeks. Study conduct includes participant training, remote support to ensure correct device use, and ongoing safety monitoring.
The study is designed to characterize changes observed during adjunctive device use, assess participant experience with home-based therapy, and evaluate device-related safety. Findings will contribute to understanding the feasibility and potential clinical role of wearable neuromodulation as an add-on treatment option in routine overactive bladder care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZIDA Add-On Therapy | Experimental | Device: ZIDA Control SockParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
- History of, failure of, or current use of neuromodulation therapies, including percutaneous or transcutaneous tibial nerve stimulation, sacral neuromodulation (InterStim), implantable tibial devices (eCoin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZIDA Control SockThe 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. | Device | ZIDA Add-On Therapy |
Primary outcome
Mean change in daily urgency urinary incontinence (UUI) episodes (3-day bladder diary)
Time frame: From baseline to at the end of treatment at 12 weeks
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.
6 secondary outcomes
Mean change in daily urgency episodes (3-day bladder diary)
Time frame: Baseline to end of treatment at 12 weeks
Mean change in daily urinary frequency (3-day bladder diary)
Time frame: Baseline to end of treatment at 12 weeks
Change in OAB-Q Short Form (1-Week Recall) Total Score
Time frame: Baseline to end of treatment at 12 weeks
Patient Global Impression of Improvement (PGI-I)
Time frame: Baseline to end of treatment at 12 weeks
Device usability score (Usability & Satisfaction Survey)
Time frame: Baseline to end of treatment at 12 weeks
Participants with ≥1 device-related adverse event
Time frame: Baseline to end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Connie Wang, MD principal investigator
Medical University of South Carolina
Eric Rovner, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Overactive Bladder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louisa Keil (843-792-1840, Keill@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in daily urgency urinary incontinence (UUI) episodes (3-day bladder diary) (time frame: From baseline to at the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.