Add-On Efficacy of Home-Based Transcutaneous Tibial Nerve Stimulation Via the ZIDA Control Sock in Adults With Overactive Bladder on Preexisting Stable Pharmacotherapy
Phase: NA
Conditions: Overactive Bladder
Sponsor: Medical University of South Carolina

Version #10; Version Date 01/06/2026 
 
Page 1 of 12 
 
PROTOCOL 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 
 
PRINCIPAL INVESTIGATOR: 
 
Dr. Connie Wang 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version #10; Version Date 01/06/2026 
 
Page 2 of 12 
 
1.0 
Objectives / Specific Aims 
 
This is a prospective, single‑arm, pre-post cohort study to look at the efficacy of the 
ZIDA Control Sock as an add-on therapy for patients with overactive bladder (OAB) 
and urgency urinary incontinence (UUI) who are already on preexisting stable OAB 
pharmacotherapy. The ZIDA sock is a new device, engineered as a wearable 
neuromodulation system in a sock, that provides transcutaneous tibial nerve 
stimulation to help relieve symptoms of OAB such as urinary urgency, urinary 
frequency, and urgency urinary incontinence. The device is non-invasive and has 
been well-tolerated overall in previous studies. A small number of studies have been 
conducted on this new device as primary therapy for OAB. We aim to study the 
effects of adding ZIDA onto the treatment plan of patients who are already on stable 
pharmacotherapy OAB with persistent symptoms. 
 
Primary Objective: To evaluate the mean change in total daily UUI episodes after 
addition of ZIDA therapy to patients on stable pharmacotherapy with OAB and 
persistent UUI. We will evaluate the mean change in episodes from baseline to weeks 
1, 4, and 8 for interim analysis, and to week 12 for final analysis. Interim analyses 
will be descriptive and will not be used for stopping the study early or hypothesis 
testing. 
 
Secondary Objectives:  (1) To assess change in daily urgency episodes (2) to assess 
change in daily urinary frequency; (3) To assess changes in patient‑reported 
outcomes including a disease specific outcomes questionnaire (OAB‑q Short Form 
(OAB‑q SF) total score) (4) to assess a patient’s impression of improvement (Patient 
Global Impression of Improvement (PGI‑I)); (5) To assess usability, satisfaction, and 
adherence (with Device Use Log and Usability and Satisfaction Survey); and (6) To 
describe any device‑related adverse events (with Adverse Event Log). 
 
We hypothesize that adding ZIDA therapy to the treatment regimen of OAB-wet 
patients already on stable pharmacotherapy will reduce their total daily urgency 
urinary incontinence episodes over 12 weeks. 
2.0 
Background 
 
Overactive bladder (OAB) is a chronic condition characterized by urinary urgency, either 
with or without urgency urinary incontinence (UUI).1-2 Those with UUI are classified as OAB-
wet, and those without UUI are classified as OAB-dry. OAB patients also typically have increased 
daytime frequency and nocturia, which is not accounted for by another pathology. It is estimated 
that between 12-16% of the population has OAB, and this condition has significant negative 
impacts on patient’s quality of life.3-5 The conservative treatment options for OAB are lifestyle 
changes, pelvic floor muscle training, and pharmacotherapy.6 The more invasive and expensive 
treatment choices include intravesical botulinum toxin injections and sacral neuromodulation.6 
Unfortunately, many OAB patients struggle to follow the lifestyle changes, while many others 
remain symptomatic despite pharmacotherapy. Some also discontinue their drug therapy due to 
cost or side effects such as dry mouth, constipation, and cognitive concerns.7 
Neuromodulation for OAB is thought to work by stimulating afferent nerves to the sacral 
spinal cord, which suppresses abnormal afferent bladder signaling and promotes guarding reflexes. 
This stimulation also regulates other central nervous system pathways, such as the prefrontal 
cortex and limbic system, which play a role in urgency perception and bladder control.8-10 
Neuromodulation can be delivered in several ways; percutaneously, transcutaneously, or more 
centrally, just depending on the clinical setting.11-13 Percutaneous tibial nerve stimulation (PTNS) 

Version #10; Version Date 01/06/2026 
 
Page 3 of 12 
 
and transcutaneous tibial nerve stimulation (TTNS) both deliver electrical stimulation adjacent to 
the medial malleolus in the lower extremity. They target the tibial nerve and primarily stimulate 
the S2 to S3 pathways, as well as the L4 and L5 pathways.11-13 Multiple studies have shown 
benefit between the different delivery methods.12-14  Systematic reviews have shown that both 
PTNS and TTNS improve OAB symptoms, including urgency, frequency, and incontinence 
episodes.15-16 
Recent studies have shown that TTNS can be used effectively and safely outside of the 
clinic. Wearable at-home TTNS devices offer comparable symptom improvement while reducing 
treatment burden for patients.17  The ZIDA Control Sock is an FDA-cleared TTNS device that can 
be self-administered at home.18 A recent study conducted on another wearable TTNS device found 
that it is safe, effective, and feasible for patients to use neuromodulation devices for at-home 
treatment sessions.19 Prior randomized controlled trials conducted on the ZIDA sock have found 
statistically significant improvements in total daily incontinence episodes and OAB‑related quality 
of life.20 
Despite first and second line therapy such as pharmacotherapy, many patients with OAB 
continue to have urinary urgency incontinence episodes. Current pharmacotherapy for OAB 
includes agents which either antagonize muscarinic receptors or stimulate beta-3 receptors in the 
lower urinary tract.  These agents are not completely effective and have dose-limiting adverse 
effects. Currently, it is unclear whether TTNS, which has a different mechanism of action as 
compared to medications, can be used as an add-on therapy in these OAB patients on 
pharmacotherapy to provide even more symptom relief.21 TTNS is non-invasive and studies show 
that it does not have significant adverse events.22-25 This study aims to evaluate whether the 
addition of the ZIDA device in patients with an incomplete response to pharmacotherapy will 
provide further relief of symptoms and improve quality of life. 
 
3.0 
Intervention to be studied  
 
The ZIDA device is a wearable, non-invasive sock, used for OAB treatment. This 
study will evaluate its use as an adjunct (add-on) therapy to standard pharmacologic 
treatment, which has not previously been studied. While studies have shown the 
efficacy of ZIDA as a stand-alone home therapy for OAB, it has not yet been 
evaluated in combination with ongoing OAB pharmacotherapy. This study will help 
us better understand whether adding TTNS to a patient’s medication regimen is 
practical, safe, and helpful for symptom control. 
 
The ZIDA device has reported minimal adverse events. During prior studies it was 
found that two patients had mild cases of foot pain and two other patients had 
unrelated urinary tract infections. These events were minimal and self-resolved 
quickly without discontinuing treatment. 
 
The treatment sessions will be the participant wearing the ZIDA Control Sock (with 
conductive gel), attaching the small control unit device, and turning this on to 
administer electrical stimulation for 30 minutes. The stimulation is set to a 
comfortable level that may produce a mild tingling sensation or mild toe movement; 
this indicates the activation of the tibial nerve. 
 
The intervention will be once weekly 30-minute sessions using the ZIDA sock for 12 
consecutive weeks. Each patient will serve as their own control.  
 
 

Version #10; Version Date 01/06/2026 
 
Page 4 of 12 
 
4.0 
Study Endpoints  
 
Our primary endpoint is to evaluate the mean change in total daily UUI episodes 
from baseline to week 12. Exploratory interim analyses at weeks 1, 4, and 8 will be 
descriptive. Our secondary endpoints include urgency episodes, total voiding 
frequency per day, QOL questionnaire Overactive Bladder Questionnaire (1-Week 
Recall) (OAB-Q SF 1W), Patient Global Impression of Improvement (PGI-I) 
responder, and any adverse events.   
 
Device usability and satisfaction will be measured at Week 12 using the Usability & 
Satisfaction Survey. This survey is a six-item questionnaire adapted from prior OAB 
studies. Five items are rated on a five-point Likert scale (1 = Strongly disagree to 5 = 
Strongly agree) to measure device ease of use, comfort, clearness of instructions, 
convenience, and patient willingness to continue therapy. There is also an open-
ended feedback question. We’ll summarize responses to get a sense of usability and 
patient experience. 
 
Adherence will be measured as the proportion of prescribed weekly sessions 
completed, based on the participant’s Device Use Log. Study staff will review logs 
during remote check-ins (Weeks 1, 4, 8, and 12). Adherence will be expressed as 
both total number and percentage of completed sessions (out of 12). 
 
Safety related to usability will also be captured through the Adverse Event Log, 
reviewed by the principal investigator at each contact. 
 
5.0 
Inclusion and Exclusion Criteria/ Study Population 
 Potential participants will be found through MUSC Urology clinic visits or electronic 
health-record (EHR) prescreening. Authorized study staff will identify adults with 
OAB-wet who are also on stable pharmacotherapy who may meet eligibility criteria.   
Inclusion 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 (antimuscarinic or β3‑agonist) 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. 
o 
A study team member at the informed consent conversation will 
assess cognitive ability and the ability to provide informed consent. 
Assessment will be based on the participant’s ability to understand the 
study procedures and accurately restate their study roles in their own 
words. No formal cognitive testing will be performed. 
 
 

Version #10; Version Date 01/06/2026 
 
Page 5 of 12 
 
Exclusion Criteria 
 
Neurologic conditions that affect bladder function, such as multiple sclerosis, 
spinal cord injury, Parkinson’s disease, or other neurogenic bladder conditions. 
 
Significant pelvic organ prolapses or other pelvic pathology that interferes with 
bladder emptying, neuromodulation efficacy, or study assessments  
 
Active urinary tract infection (UTI) or unexplained hematuria at screening 
 
Clinically significant post-void residual (PVR) volume above threshold (e.g., 
>100 mL) 
 
History of, failure of, or current use of neuromodulation therapies, including 
percutaneous or transcutaneous tibial nerve stimulation (PTNS/TTNS), 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 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 of GI, GU or GYN origin, 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) 
 
6.0 
Number of Subjects 
20 
7.0 
Setting 
 
The study will be conducted at MUSC’s Department of Urology. Participants will administer their 
treatment at home. 
 
8.0 
Recruitment Methods 
Potential participants will be identified through MUSC Urology clinic visits or by using Epic EHR 
review to locate adults with a diagnosis of OAB-wet who are on stable pharmacotherapy and may 
meet eligibility criteria. Prescreening will be performed by authorized study staff through chart 
review only; no direct patient contact will occur at this stage. When a potentially eligible patient is 
identified through chart review, the study team will notify the treating clinician prior to the 
patient’s upcoming appointment. The treating clinician will briefly introduce the study during the 
clinical encounter. If the patient is interested in participating in this study, the clinician will ask for 
permission from the patient for the research team to follow up with them. Study staff will only 

Version #10; Version Date 01/06/2026 
 
Page 6 of 12 
 
contact potential participants after permission has been confirmed. The research coordinator will 
be present in clinic to come speak with the patient. 
Some eligible patients may be missed during prescreening. Their treating clinician (including 
attending physicians, fellows, and PAs within the MUSC Urology clinic) also have the option to 
identify eligible patients during clinic. In these cases, clinicians may briefly inform the patient 
about the study and, if the patient is interested, get permission for the research team to follow up. 
The research coordinator will be present in clinic to come speak with the patient. 
Recruitment will occur on a rolling basis over approximately 10 to 14 months, with an estimated 
enrollment rate of 1.5 to 2 participants per month.  
9.0 
Consent Process 
Informed consent will be obtained from all participants before any study-related screening 
procedures are conducted. The consent process will take place in a private setting. Consent 
will be obtained by IRB-approved study personnel either in person during the participant’s 
screening visit (which may coincide with a routine clinic appointment) or remotely via a 
secure HIPAA-compliant telehealth platform. Participants will be provided the consent 
form and given adequate time to review it and ask questions before signing. Individuals 
who wish to consider participation further will be offered at least 24 hours for reflection 
before providing consent. The study team will make sure that participants understand that 
their participation is voluntary and that their refusal or withdrawal at any time will not 
affect their clinical care. This consent form will explain that screening procedures to 
confirm final eligibility for enrollment will take place after consent. The participant will 
receive copy of their signed consent form.  
 
10.0 Study Design / Methods 
After providing informed consent, participants will complete a 14-week study consisting of 
a screening visit, baseline visit, 12 weeks of home treatment, remote check-ins, and a final 
in-person visit.  
Screening Visit:  
Participants may complete informed consent either remotely before the screening visit or in 
person at the time of screening, depending on preference. Once they have been consented, 
they will begin the screening visit, which may occur with a routine clinic appointment. At 
the screening visit a physical exam will occur. If a patient is already having the procedure 
or exam per standard of care for their clinic visit, we will not repeat the procedure but will 
instead review the medical record for the results. During this visit, the following will 
occur: 
 medical history and medication review, 
 physical examination, 
 urinalysis (to assess for hematuria or UTI), 
 urine dipstick pregnancy test for women of childbearing potential (the test will be 
done on the same urinalysis urine sample when possible), 

Version #10; Version Date 01/06/2026 
 
Page 7 of 12 
 
 post-void residual (PRV) volume measurement. This will be conducted by using a 
non-invasive ultrasound scanner after voluntary voiding to assess for incomplete 
bladder emptying and rule out urinary retention.  
 completion of baseline questionnaires, including the OAB-Q SF 1W and the PGI-S. 
The OAB-Q SF 1W is a validated 19-item questionnaire that is used to assess 
patient quality of life. The PGI-S is a single item scale that measures symptom 
severity. Study questionnaires may be completed on paper or electronically through 
REDCap, depending on participant preference. 
After these screening procedures are done and eligibility is confirmed, the participants will 
be enrolled in the study. Study-related procedures will only be conducted by clinicians 
who are members of the study team. 
Baseline Visit (same day or on a different day):  
 Participants go over the screening results and confirm their enrollment in the study.  
 Participants will be instructed that they should remain on stable OAB 
pharmacotherapy throughout the study. 
 They will receive the ZIDA device and get device training based on the ZIDA 
manufacturer’s IFU. They will be instructed to call the study team if, while using 
the device, they experience any pain, skin irritation, or technical problems. 
 They will also be given a 3-day bladder diary and instructions on how to complete 
it at home over three consecutive days before starting device therapy. This diary 
records voiding time, urgency, and urgency-urinary-incontinence episodes. 
 They will also receive the Device Use Logs, Adverse Event Logs, and Bladder 
Diaries for the entirety of the study. 
 The baseline visit may occur on the same day as the screening visit or may be 
scheduled for a later date, depending on when all screening procedures are 
completed and eligibility is confirmed. If all screening assessments are finished 
during the initial clinic encounter and the participant has enough time to complete 
the baseline visit, then the baseline visit could be completed. Or, if preferred by the 
participant, the baseline visit may also be conducted remotely after the screening 
visit. If this is the case (once eligibility is confirmed) the participant will receive all 
of the required study materials; the ZIDA device, IFU, conductive gel, and all study 
logs (Device Use Log, Adverse Event Log, and bladder diaries). Then device 
training will be conducted either in person or remotely before the participant begins 
device use. Participants who do not have time to complete all screening and 
baseline activities in a single visit may return for one additional visit (combined 
Screening and Baseline visit) to finish any screening procedures and the baseline 
visit. In all scenarios, the participants will complete all screening procedures, then 
once they meet eligibility criteria, will receive device training, and receive all study 
materials before beginning the intervention period. 
Intervention Period (Weeks 1–12):  
 Participants will self-administer the ZIDA therapy once a week for 30 minutes. 
They choose a day of the week that works best for them. For each session, the 
participant will be seated comfortably, they will put conductive gel on the inside of 
the ZIDA sock, connect the control unit, and turn it on to begin electrical 

Version #10; Version Date 01/06/2026 
 
Page 8 of 12 
 
stimulation. After 30 minutes, the device will automatically turn off. Participants 
take off the device, clean off any leftover gel. Participants will complete one 
session every week for 12 weeks (ideally on the same day ±24 hours). Reminders 
may be sent by telephone, secure email, or text message through a HIPAA-
compliant system, depending on participant preference. Reminder messages will be 
brief and only related to the study (e.g., “Please remember to do your session this 
week”). 
 They will be asked to complete a Device Use Log after each session where they 
will write down the date, duration, and any notes about the session. 
 Study staff will conduct remote study check ins at weeks 1, 4 and 8.  Participants 
may choose to do these using a HIPAA-compliant telehealth platform or a phone 
call. During these check ins, the study team will confirm that patients are using and 
adhering to the session schedules by reviewing the Device Use Log. During remote 
visits, adherence will be confirmed either verbally by the participant reading their 
Device Use Log entries during the call, or through secure REDCap data entry if the 
participant prefers to complete their weekly log electronically. During these remote 
visits, the study team will record any adverse events or side effects. Adverse events 
and device-related complaints are documented on a standardized Adverse Event 
Log and reviewed by the study team and/or principal investigator. 3 Day Bladder 
Diaries: Participants will complete additional 3-day bladder diaries at Weeks 4, 8, 
and 12. Reminders may be sent by telephone, secure email, or text message through 
a HIPAA-compliant system, depending on participant preference. Reminder 
messages will only have neutral content that is relevant to the study (e.g., “Please 
remember to complete your bladder diary this week”). Participants may complete 
the 3-day bladder diaries on paper or electronically on REDCap given their 
preference. Paper diaries may instead be reviewed verbally during the telehealth 
check-in or collected at the final visit. 
 
Final Visit (Week 12) In person study visit:  
 Participants will return their bladder diaries 
 Patients will again complete the OAB-Q SF 1W, PGI-S, 
 Patients will complete a PGI-I, and Usability and Satisfaction Survey 
questionnaires. The PGI-I is a single item scale that measures symptom 
improvement. 
 PVR measurement will be repeated using a bladder scanner 
 All Device Use Logs will be collected and reviewed with the participant.  
 Adverse events will be collected, and the Adverse Event Log will be reviewed with 
the participant. 
The participant will return the device and any additional supplies they had received from 
the study team. Total participation is approximately 14 weeks.  
11.0 Data Management  
All data will be limited to clinical and patient-reported outcomes (e.g., bladder diaries, 
questionnaires, adverse event logs). Collected data will include demographic information 

Version #10; Version Date 01/06/2026 
 
Page 9 of 12 
 
(age, sex), OAB history, current medications, baseline and follow-up diary metrics, and 
questionnaire scores. Research data will be coded. Identifiable patient information will be 
stored in a linking document and stored separately from the research data in a password-
protected software accessible only to authorized study staff. All study staff will complete 
CITI training in human subjects research and will be HIPAA compliant. Only de-identified 
patient data will be removed from MUSC servers. Hard copy documentation (like consent 
forms and bladder diaries) will be stored in locked cabinets within MUSC Urology 
research offices. Any data collected electronically (eg. Electronic consents or 
questionnaires) will be stored in REDCap. Paper responses will be entered into REDCap 
by study staff, and hard copies stored as source documentation. If any participants 
complete electronic consent via REDCap’s e-consent module, those signed forms will be 
stored securely within REDCap under MUSC’s encrypted server. 
 
For this single arm pre/post study design, we plan to enroll a total of 20 participants. 
Since we expect no more than 20% drop-out, this will yield complete data on at least 
16 participants. A sample size of n=16 provides 85% power to detect modest 
changes (effect sizes of 0.7) in study outcomes, including Total Daily Incontinence 
episodes).  Earlier work by Cava & Orlin (2022) suggest that the device may yield 
an even larger decline in incontinence episodes (i.e. from 1.2 ± 0.8 at baseline down 
to 0.3 ± 0.3, at week 12, corresponding to an effect size of 1.4), meaning that we 
may likely have even greater statistical power. This sample size would also provide 
sufficient power (>80%) to detect changes in secondary outcomes, including Quality 
of Life (OAB-Q SF 1W total score). While primary analysis compares baseline to 
week 12, repeated-measures models will incorporate interim timepoints (weeks 1, 4, 
8) descriptively.  
 
Initially, descriptive statistics will be used to characterize the study participants at 
baseline and at follow-up.  Continuous outcomes (i.e. measures of incontinence and 
quality of life) will be compared pre- and post-use of the device using paired t-tests, 
or Wilcoxon signed rank tests (if necessary). The proportion of participants who 
have no incontinence at follow-up will be reported, and these percentages will be 
compared using McNemar’s tests for paired binomial proportions. The results of this 
study will be vital for helping to design a larger, definitive 2-arm randomized 
controlled trial.  
12.0 Withdrawal of Subjects 
 
Participants could be withdrawn from the study if they no longer meet eligibility 
criteria (like ceasing their medication use or are non-adherent to device use) or for 
safety concerns (like an adverse reaction). 
 
Participants can withdraw from the study at any time without penalty by notifying 
the Principal Investigator or a member of the study team. Data collected up to that 
point will be retained unless the participant requests their data be removed.  
 
If a participant withdrawals during the study, the reason for withdrawal will be 
documented in the study enrollment and tracking log maintained by the study team. 
13.0 Risks to Subjects 
 
Possible risks of ZIDA use include mild tingling, warmth, or discomfort at the ankle 
during use, and mild self-resolving skin redness or irritation from electrode 
adhesive.  

Version #10; Version Date 01/06/2026 
 
Page 10 of 12 
 
 
Some of the study questionnaires will ask the patients about their urinary symptoms 
and its impact on their quality of life. This could cause mild embarrassment or 
emotional discomfort. Participants will be informed that they may skip any question 
they do not wish to answer. 
 
There is a risk of loss of confidentiality, but every effort will be made to mitigate 
that risk by coding the data and storing it securely. 
14.0 Potential Benefits to Subjects or Others 
 
It is possible, but cannot be guaranteed, that the ZIDA device may result in a 
reduction in urgency, frequency, and incontinence episodes. 
 
More broadly, this study helps clarify how TTNS and medication might work 
together for patients with OAB.  
 
Risks are minimal and resolvable, as seen in prior studies. 
15.0 Sharing of Results with Subjects 
 
De-identified study results will be available to participants after the study is 
completed, either via mailed summary or secure email. Individual-level results, such 
as each participant’s own bladder diary summaries, questionnaire scores (e.g., OAB-
Q SF or PGI-I), and clinical progress measures, can be reviewed with participants 
during follow-up visits in clinic or remotely if requested. 
16.0 Drugs or Devices  
 
The ZIDA Control Sock is an FDA-cleared (Class II, K192731, product code NAM) 
at-home device for OAB treatment. It is cleared to treat OAB and associated 
symptoms of urinary urgency, urinary frequency, and urge incontinence. All device 
operation and safety procedures will follow the manufacturer’s Instructions for Use 
(IFU). A copy will be included in the study binder and provided to participants. 
 
Devices will be stored at the MUSC Urology office in a locked room accessible only 
to authorized study staff. Devices will be logged, numbered, and dispensed only to 
enrolled participants. 
 
Only trained study staff will instruct participants in device operation. Participants 
will self-administer therapy according to IFU (one 30-minute session weekly for 12 
weeks).  
 
 
 
 
 
 
 
 
 
 
 

Version #10; Version Date 01/06/2026 
 
Page 11 of 12 
 
References 
 
1. Wallace KM, Drake MJ. Overactive bladder. F1000Res. 2015;4:F1000 Faculty Rev-1406. Published 
2015 Dec 7. PMID: 26918151. 
2. Abrams P, et al. The standardisation of terminology in lower urinary tract function: report from the 
Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 
2002;21(2):167-178. PMID: 11979331.  
3. Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the 
United States. World J Urol. 2003;20(6):327-336. PMID: 12811491. 
4. Milsom I, Abrams P, Cardozo L, et al. How widespread are the symptoms of an overactive bladder 
and how are they managed? A population-based prevalence study. BJU Int. 2001;87(9):760-766. 
PMID: 11412210. 
5. Coyne KS, Sexton CC, Irwin DE, Kopp ZS, Kelleher CJ, Milsom I. The impact of overactive bladder, 
incontinence and other lower urinary tract symptoms on quality of life, work productivity, 
sexuality and emotional well-being in men and women: results from the EPIC study. BJU Int. 
2008;101(11):1388-1395. PMID: 18454794. 
6. Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-
neurogenic) in adults: AUA/SUFU Guideline (2024 update). J Urol. 2024;211(3):645-659.  
7. Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU Guideline on the Diagnosis and 
Treatment of Idiopathic Overactive Bladder. J Urol. 2024;212(1):11-20. 
8. de Groat WC, Yoshimura N. Mechanisms underlying the recovery of lower urinary tract function 
following spinal cord injury. Prog Brain Res. 2006;152:59-84. PMID: 17027738. 
9. Finazzi-Agrò E, Rocchi C, Pachatz C, et al. Percutaneous tibial nerve stimulation produces effects on 
brain activity: results from a functional magnetic resonance imaging study in humans. J Urol. 
2009;182(6):2070-2076. PMID: 19836700. 
10. Tai C, Roppolo JR, de Groat WC. Neuromodulation of bladder afferent pathway for the treatment of 
overactive bladder. Neurotherapeutics. 2007;4(2):215-223. PMID: 17514118. 
11. Finazzi-Agrò E, Campagna A, Sciobica F, et al. Posterior tibial nerve stimulation: is the once-a-week 
protocol the best option? Eur Urol. 2005;48(1):181-185. PMID: 15953651. 
12. Amarenco G, Ismael SS, Even-Schneider A, et al. Urodynamic effect of acute transcutaneous 
posterior tibial nerve stimulation in overactive bladder. J Urol. 2003;169(6):2210-2215. PMID: 
12771763.  
13. Peters KM, Macdiarmid SA, Wooldridge LS, et al. Randomized trial of percutaneous tibial nerve 
stimulation versus extended-release tolterodine: results from the overactive bladder innovative 
therapy trial. J Urol. 2009;182(3):1055-1061. PMID: 19616807. 
14. Wang M, Jian Z, Ma Y, Jin X, Li H, Wang K. Percutaneous tibial nerve stimulation for overactive 
bladder syndrome: a systematic review and meta-analysis. Int Urogynecol J. 2020;31(12):2457-
2471. PMID: 32681345. 
15. Booth J, Connelly L, Dickson S, Duncan F, Lawrence M. The Effectiveness of Transcutaneous Tibial 
Nerve Stimulation (TTNS) for Adults With Overactive Bladder Syndrome: A Systematic Review. 
Neurourol Urodyn. 2018;37(2):528-541. PMID: 28731583. 
16. Ghavidel-Sardsahra A, Ghojazadeh M, Rahnama'I MS, et al. Efficacy of Percutaneous and 
Transcutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder and 
Interstitial Cystitis/Painful Bladder Syndrome: A Systematic Review and Meta-Analysis. 
Neurourol Urodyn. 2022;41(2):539-551. PMID: 35032328. 
17. Vaca-Benavides DA, Ju W, Gonzalez C, et al. The Importance of Electrical Parameters on 
Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Syndrome: A Systematic Review 
and Meta-Analysis. Age Ageing. 2025;54(7):afaf203.   

Version #10; Version Date 01/06/2026 
 
Page 12 of 12 
 
18. U.S. Food and Drug Administration. 510(k) Summary K192731: ZIDA Control Sock (Exodus 
Innovations Ltd). Silver Spring, MD: FDA; 2020.  
19. Liao L, Li X, Chong T, et al. Efficacy and Safety of Tibial Nerve Stimulation Using a Wearable 
Device for Overactive Bladder. BJU Int. 2024;133(6):760-769.   
20. Cava JL, Orlin J, El-Haddad T, et al. Transcutaneous posterior tibial nerve stimulation using the ZIDA 
home-use device for overactive bladder: a randomized, double-blind, sham-controlled trial. Int 
Urol Nephrol. 2022;54(7):1623-1633. PMID: 35595844. 
21. Lee UJ, MacDiarmid S, Matthews CA, Gillespie E, Peters KM. Tibial Nerve Stimulation for Urge 
Urinary Incontinence and Overactive Bladder: Narrative Review of Randomized Controlled Trials 
and Applicability to Implantable Devices. Adv Ther. 2024;41(7):2635-2654. PMID: 38748331. 
22. Stanley RF, Meyer I, Blanchard CT, Richter HE. Posterior tibial nerve stimulation with versus 
without mirabegron: a randomized controlled trial. Int Urogynecol J. 2024;35(8):1709-1717. 
PMID: 38588590.  
23. Peters KM, MacDiarmid SA, Wooldridge LS, et al. Efficacy and safety of the implantable eCoin tibial 
neuromodulation device for refractory urgency urinary incontinence: results of the pivotal 
randomized trial. J Urol. 2022;208(6):1353-1362. PMID: 36106697.  
24. Vecchioli-Scaldazza C, Morosetti C, Berouz A, Giannubilo W, Ferrara V. Effectiveness and durability 
of solifenacin versus percutaneous tibial nerve stimulation versus their combination for the 
treatment of women with overactive bladder syndrome: a randomized controlled study with a ten-
month follow-up. Int Braz J Urol. 2018;44(1):102-108. PMID: 23548260.  
25. Chen G, Liao L. Transcutaneous tibial nerve stimulation in women with overactive bladder syndrome: 
a randomized controlled trial. Int Urogynecol J. 2021;32(2):297-304. PMID: 34161360.