INvestigation of TENS Efficacy Versus Posterior Tibial Nerve Stimulation for Overactive Bladder
Phase: NA
Conditions: Overactive Bladder, Overactive Bladder Syndrome, Urinary Urge Incontinence, Urinary Bladder, Overactive, Urinary Incontinence, Urge
Sponsor: University of New Mexico

PROTOCOL TITLE: INTENSE: INvestigation of TENS Efficacy versus Posterior Tibial 
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TITLE PAGE: 
 
PROTOCOL TITLE: 
INTENSE: INvestigation of TENS Efficacy versus Posterior Tibial Nerve Stimulation for 
overactive bladder 
 
NCT NUMBER:  Not yet assigned 
Document Date:  2/11/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL TITLE: 
INTENSE: INvestigation of TENS Efficacy versus Posterior Tibial Nerve Stimulation for 
overactive bladder 
PRINCIPAL INVESTIGATOR: 
Kate Meriwether, MD  
Department of Obstetrics and Gynecology  
 
ADMINISTRATIVE CONTACT: 
 
Name: Karen Taylor 
 
Department of OB/GYN 
VERSION NUMBER: 
3 
DATE: 
Include the date of submission or revision. 
REGULATORY FRAMEWORK: 
Please indicate all that apply (please note that the regulatory framework does not mean 
the funding source): 
☐ 
DOD (Department of Defense) 
☐ 
DOE (Department of Energy) 
☐ 
DOJ (Department of Justice) 
☐ 
ED (Department of Education) 
☐ 
EPA (Environmental Protection Agency) 
☒ 
FDA (Food and Drug Administration) 
☒ 
HHS (Department of Health and Human Services) 
☐ 
VA 
☐ 
Other:       
 
FUNDING: 
This protocol is not currently funded.  
 
CLINICAL TRIALS 
Is this a clinical trial per the NIH definition of a Clinical Trial?   ☒ Yes   ☐ No 

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NIH Definition of a Clinical Trial:  
“A research study in which one or more human subjects are prospectively assigned to one or 
more interventions. An "intervention" is defined as a manipulation of the subject or subject’s 
environment for the purpose of modifying one or more health-related biomedical or behavioral 
processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; 
devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face 
interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, 
development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies 
(which may include placebo or other control) to evaluate the effects of those interventions on  
health-related biomedical or behavioral outcomes.”  
Use the following four questions to determine the difference between a clinical study and a 
clinical trial:        
 
Does the study involve human participants? ☒ Yes   ☐ No 
 
Are the participants prospectively assigned to an intervention? ☒ Yes   ☐ No 
 
Is the study designed to evaluate the effect of the intervention on the participants? ☒ Yes  
☐ No  
 
 Is the effect being evaluated a health-related biomedical or behavioral outcome? ☒ Yes   
☐ No 
 
Note that if the answers to the 4 questions are yes, your study meets the NIH definition of a 
clinical trial, even if…  
• You are studying healthy participants 
• Your study does not have a comparison group (e.g., placebo or control) 
• Your study is only designed to assess the pharmacokinetics, safety, and/or maximum 
tolerated dose of an investigational drug 
• Your study is utilizing a behavioral intervention 
 
If yes to all 4 questions, please confirm that the research team is familiar with and agrees to 
comply with the investigator requirement to register the study on the ClinicalTrials.gov database. 
Additionally, the approved consent document(s) must be uploaded to the ClinicalTrials.gov 
database   ☒ Yes   ☐ No  
For any assistance with registration of your trial or the requirements, please contact HSC-
CTSCResearchConcierge@salud.unm.edu  
 

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Table of Contents 
1. 
Objectives ................................................................................................................................ 6 
2. 
Background .............................................................................................................................. 6 
3. 
Study Design............................................................................................................................ 8 
4. 
Inclusion and Exclusion Criteria ............................................................................................. 8 
5. 
Number of Subjects ............................................................................................................... 10 
6. 
Study Timelines ..................................................................................................................... 11 
7. 
Study Endpoints:.................................................................................................................... 11 
8. 
Research Setting .................................................................................................................... 11 
9. 
Resources Available .............................................................................................................. 12 
10. 
Prior Approvals .................................................................................................................. 13 
11. 
Multi-Site Research ........................................................................................................... 13 
12. 
Procedures .......................................................................................................................... 13 
13. 
Data Analysis ..................................................................................................................... 17 
14. 
Provisions to Monitor the Data to Ensure the Safety of Subjects ...................................... 18 
15. 
Withdrawal of Subjects ...................................................................................................... 18 
16. 
Data Management/Confidentiality ..................................................................................... 19 
17. 
Data and Specimen Banking .............................................................................................. 19 
18. 
Risks to Subjects ................................................................................................................ 20 
19. 
Potential Benefits to Subjects ............................................................................................ 20 
20. 
Recruitment Methods ......................................................................................................... 21 
21. 
Provisions to Protect the Privacy Interests of Subjects ...................................................... 21 
22. 
Economic Burden to Subjects ............................................................................................ 22 
23. 
Compensation .................................................................................................................... 22 
24. 
Compensation for Research-Related Injury ....................................................................... 23 
25. 
Consent Process ................................................................................................................. 23 
26. 
Documentation of Consent ................................................................................................ 24 
27. 
Study Test Results/Incidental Findings ............................................................................. 25 
28. 
Sharing Study Progress or Results with Subjects .............................................................. 25 
29. 
Inclusion of Vulnerable Populations .................................................................................. 25 
30. 
Community-Based Participatory Research ........................................................................ 25 
31. 
Research Involving American Indian/Native Populations ................................................. 25 
32. 
Transnational Research ...................................................................................................... 25 
33. 
Drugs or Devices................................................................................................................ 25 
34. 
Principal Investigator’s Assurance .................................................................................... 26 
35. 
CHECKLIST SECTION .................................................................................................... 26 
36. 
Partial Waiver of Consent for Screening/Recruitment ...................................................... 26 
37. 
Partial Waiver of HIPAA Authorization for Screening/Recruitment ................................ 27 
38. 
Waiver of Documentation of Consent ............................................................................... 27 
39. 
Alteration of Consent ......................................................................................................... 27 
40. 
Full Waiver of Consent/Parental Permission ..................................................................... 27 
41. 
Full Waiver of Consent/Parental Permission (Public Benefit or Service Programs) ......... 27 
42. 
Full Waiver of HIPAA Authorization (Checklist) ............................................................. 28 
43. 
Other Waiver Types (Checklist) ........................................................................................ 28 
44. 
Vulnerable Populations (Checklist) ................................................................................... 28 

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45. 
Medical Devices (Checklist) .............................................................................................. 28 
46. 
Export Control (Checklist) ................................................................................................. 29 
47. 
Data Transfer/Sharing/Storage (Checklist) (required –do not delete even if the 
answer is “No”) ........................................................................................................................... 29 
48. 
Specimen Transfer/Sharing (Checklist) (required –do not delete even if the answer is 
“No”) 30 
 
 

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1. Objectives 
1.1. The objective of this research is to perform a non-masked, non-inferiority 
randomized controlled trial to assess the quality of life (QOL) of women with 
idiopathic overactive bladder (OAB) before and after treatment with percutaneous 
tibial nerve stimulation (PTNS) or transcutaneous electrical nerve stimulation 
(TENS) of tibial nerve. The target population is patients with OAB who previously 
failed first- and second-line treatments and desire non-surgical management. 
1.2. Our central hypothesis is that a TENS unit is non-inferior to PTNS for improving the quality 
of life and symptom distress of women with OAB. The specific aims are: 
1.2.1. To compare the effects on health-related quality of life (HRQoL) and symptom bother as 
measured by the change in score from baseline of the Overactive Bladder questionnaire 
(OAB-q) in women with urgency urinary incontinence or overactive bladder before and 
after PTNS versus TENS after 3 months of therapy. Secondary outcomes related to this 
aim include change in symptom bother alone, as measured by the OAB-q symptom 
subscale and change in HRQL alone, as measured by the OAB-q HRQL subscale from 
baseline. Hypothesis: TENS will demonstrate similar effects on symptoms and 
symptom-associated HRQoL in the treatment of women with OAB compared to PTNS.  
1.2.2. To compare the rates of treatment success, as defined as 50% or more reduction of 
urinary incontinence episodes or 25% or more reduction in day or night voids in women 
with OAB before and after PTNS versus TENS after 3 months of therapy. The number 
of urinary incontinence episodes, number of voids per day and number of voids per night 
will be measured by a three-day voiding diary. Hypothesis: TENS will demonstrate 
similar rates of treatment success in women with OAB compared to PTNS.  
1.2.3. To perform a comparative analysis of patient satisfaction and compliance between TENS 
and PTNS. Patient satisfaction will be measured by a patient satisfaction question (PSQ). 
Patient compliance will be measured by number of treatment sessions completed as 
verified by clinical records of completed PTNS treatments and TENS device 
interrogation. Hypothesis: Women will be satisfied with both TENS and PTNS 
treatment and will have greater treatment compliance with TENS compared to PTNS.  
2. Background 
OAB is a common condition affecting 16.9% of women in the US, with a marked increase 
in the prevalence of urgency urinary incontinence (UUI) after the age of 441. The 
International Continence Society (ICS) and International Urogynecologic Association 
(IUGA) define OAB as a symptom syndrome characterized by urinary urgency, usually 
accompanied by frequency and nocturia, with or without UUI2. The burden of OAB is not 
only substantial but pervasive. The estimated annual cost of OAB in the US is over $12 
billion3. On an individual level, it significantly impairs the quality of life of those who suffer 
from it, affecting social, psychological, occupational, domestic, physical and sexual aspects 
of their lives4,5.  

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The 2019 American Urological Association/Society of Urodynamics, Female Pelvic 
Medicine & Urogenital Reconstruction (AUA/SUFU) Guidelines for the management of 
OAB includes conservative first and second line treatments with behavior and 
pharmacologic therapies6. However, not all OAB patients respond to or tolerate conservative 
treatment. The discontinuation rate of anticholinergics is 58.8% at 6 months7, worsening to 
74.8% at 1 year and 87% at 3 years8. Hence, patients often seek alternate therapies. Third 
line options include PTNS, sacral neuromodulation (SNS) and intradetrusor 
onabotulinumtoxinA injections, while fourth line therapies are more invasive and morbid 
surgical treatments such as urinary diversion or augmentation cystoplasty6.  SNS has a 
success rate of 54%9 but requires the implantation of a permanent device, which may deter 
some patients. Additionally, there are frequent and moderately severe adverse effects 
associated with SNS, including pain, lead migration, infection/irritation, electric shock and 
the need for additional surgeries in over 30% of patients6,10. Costs for SNS are substantially 
higher than other treatments. A cost analysis comparing pharmacologic, SNS, PTNS and 
onabotulinumtoxinA by Kraus et al. found PTNS had the lowest mean costs at $6959 over 
24 months, while SNS had the highest costs at $29,70211. Intradetrusor onabotulinumtoxinA 
is another effective treatment with success rates of 60-70%12–14. However it is expensive11 
and associated with adverse effects like urinary tract infections (19.7%) and urinary 
retention requiring temporary clean intermittent self-catherization (8.4%)15. 
PTNS is a cost effective and less invasive third line treatment option for OAB patients. 
Multiple studies have examined the efficacy and safety of PTNS for OAB in adults and 
children. The SUmiT Trial demonstrated PTNS was superior to sham for both objective 
(voids per day and incontinence episodes) and subjective (improvement in bladder 
symptoms) parameters of OAB16 and was shown to have sustained safety and efficacy at 24 
months17,18. The OrBIT Study comparing PTNS to extended release tolterodine 
demonstrated significant improvements in incontinence episodes, voids per day and nocturia 
in both arms. However, PTNS showed greater subjective improvement over tolterodine for 
overall health related quality of life (HRQOL)18,19 with sustained effects at 12 months18,20. A 
meta-analysis of PTNS concluded improvement in OAB symptoms is comparable between 
PTNS and antimuscarinics, but PTNS offers a better adverse event profile21. PTNS has mild, 
transient and rare adverse effects occurring 1-2% and include bruising or bleeding at the 
needle site, tingling and mild pain with no serious adverse events reported16,19,21. In 
comparison, reported adverse events of antimuscarinics range from 9.7-63% and most 
commonly include constipation, dry mouth, voiding dysfunction, and urinary tract infection 
(UTI)22. Current standard treatment protocols involve weekly 30-minute treatments for 12 
weeks total. This can pose a significant barrier for patients, requiring multiple clinic visits, 
time off work, and frequent transportation that can affect compliance and therefore treatment 
success and patient satisfaction.  
A more patient-centered option for OAB with similar success rates may be TENS. TENS is 
commonly used in physical therapy to treat pain, but recent studies have demonstrated its 
effectiveness in treating OAB.  When compared to controls, patients receiving TENS had 
significantly greater OAB symptoms improvement (48-93%), UUI cure rates (24-45%) and 
patient satisfaction23–25. TENS is an incredibly safe and non-invasive therapy with no 
adverse events reported by any study reporting use of TENS in a systematic review of 10 

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RCTs and 3 prospective cohorts 25. Women also view TENS as a convenient, beneficial and 
acceptable treatment of OAB. A qualitative study by Daly et al. revealed TENS home 
treatment allowed for flexibility to accommodate lifestyle and work needs, unlike clinic 
visits, and provided a sense of control and empowerment over their OAB symptoms that 
facilitated their willingness and motivation to continue treatment and improve self esteem 26. 
The home was viewed as a safe space for women to receive treatment without the stress and 
embarrassment of clinic visits for their condition. Women in the study often viewed TENS 
as both a mental and physical treatment26.  The at home self-administration makes TENS 
treatment a viable way to reduce obstacles patients face accessing care. This is encouraging 
evidence that TENS may provide a safe, effective, convenient and possibly preferred 
alternative treatment to PTNS for OAB.  
To date, there are very limited studies directly comparing PTNS and TENS for the treatment 
of OAB. Ramírez-García et al. compared PTNS to transcutaneous stimulation of the 
posterior tibial nerve for the treatment of OAB and demonstrated transcutaneous tibial nerve 
stimulation was non-inferior in decreasing daytime frequency, urinary incontinence episodes 
and quality of life27. However, both interventions in this study were performed in a clinical 
setting and once a week, overlooking the two significant advantages TENS provides over 
traditional PTNS: self-administered treatment at home and increased frequency of treatment. 
Another RCT comparing PTNS to TENS, in which the TENS group received daily 
treatments at home, did not demonstrate a difference between groups in reductions of 
incontinence episodes, number of voids or quality of life measures (unpublished data). 
However, this study was underpowered to determine equivalency or non-inferiority. The 
authors are unaware of any other trials directly comparing TENS and PTNS treatment for 
OAB. Given this gap in knowledge and the advantages TENS can offer to reduce barriers to 
accessing healthcare, we propose to study home TENS versus traditional, office-delivered 
PTNS for women with OAB. This innovative research shows promise in helping patients 
overcome a costly and embarrassing condition in the privacy of their own homes, on their 
own time.  
3. Study Design 
We plan to perform an unmasked, non-inferiority randomized controlled trial to determine if 
the quality of life is improved with the use of TENS compared to PTNS for urgency urinary 
incontinence and overactive bladder. The target population is patients with OAB and/or 
urgency urinary incontinence (UUI) who present to the urogynecology clinic either at the 
University of New Mexico Hospital (UNMH) or Sandoval Regional Medical Center 
(SRMC). Women will be informed of the arm of the study to which they are randomized, as 
the intervention is unable to be masked. Masking is not possible with this study design due 
to the nature of the interventions. All women will give written consent prior to enrollment. 
4. Inclusion and Exclusion Criteria 
4.1. We will recruit women with OAB and/or UUI who present to the University of New Mexico 
Urogynecology practice at UNM Eubank Clinic (UNM) or Sandoval Regional Medical 
Center (SRMC) with OAB, urgency urinary incontinence (UUI) without other types of 
incontinence, or mixed urinary incontinence with urge predominant-symptoms who have 
failed a trial of at least one medication. To confirm diagnosis and eligibility, we will conduct 

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a standard intake history and physical, complete with cough stress test, POP-Q pelvic 
examination, urinalysis and urine culture. If the potential participant predominantly 
complains of OAB or UUI, she will be introduced to the study and provided with written 
information that may help her decide if participation in the study is right for her.  All 
potential participants will be counseled about possible treatment options for OAB and UUI 
including non-surgical and surgical techniques. If a woman is withdrawn from the study 
either by her desire or that of the research staff, or does not desire to participate, she will be 
offered the same treatment options. Her follow up appointments will be the same regardless 
of participation in the study. The rationale for targeting this population is that these are 
women who would routinely be offered third line treatments for OAB or UUI.  
4.2. Patients will be enrolled if they meet the inclusion and do not meet the exclusion criteria.  
4.2.1. Inclusion Criteria 
• Female Subjects ≥18 years of age 
• OAB, UUI or Mixed Urinary Incontinence with urgency predominant symptoms 
and more bother from UUI than stress urinary incontinence  
• Failed trial of conservative therapy (including bladder training, fluid modification, 
diet modification, caffeine restriction, or pelvic floor training) 
• Failed trial of at least one pharmacologic treatment (anticholinergics, β3-
adrenoceptor agonist) either due to inability to take the medication, adverse 
reaction to medication, or no improvement on medication 
• Willing to complete study questionnaires 
• Willing to adhere to 12 office visits for PTNS over 3 months if randomized to that 
arm 
• No contraindication to undergoing PTNS or TENS therapy  
4.2.2. Exclusion Criteria 
• Age < 18 years 
• Presence of urinary fistula 
• Male genital anatomy 
• Undergoing evaluation or treatment of recurrent (2 or more infections in the last 6 
months or 3 or more infections in the last 12 months) or current urinary tract 
infection  
• Current Bladder stones 
• Bladder cancer or suspected bladder cancer 
• Gross Hematuria 
• Pregnancy or planning to become pregnant during the study  
• Cognitive impairment  
• Central or peripheral neurologic disorders such as multiple sclerosis, Parkinson’s 
disease, spina bifida, spinal cord lesions, etc. 
• Metal implants such as pacemaker, implantable defibrillator, or metal implants 
where PTNS or TENS device needs to be placed (ankle/leg) 
• Uncontrolled diabetes  
• Diabetes with peripheral nerve involvement 

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• Current use of anticoagulants (excluding aspirin)  
• Current use of anticholinergics or use within the last 4 weeks 
• Current use of botox bladder injections or bladder botox injection within the last 
year (12 months) 
• Current use of sacral neuromodulation therapy or currently implanted sacral 
neuromodulation device or leads 
• Bladder outlet obstruction 
• Urinary retention or gastric retention 
• Painful Bladder Syndrome/Interstitial Cystitis 
• Unable to be contacted for follow up by telephone 
• Inability to speak/read/understand English or Spanish 
4.3. We have decided to only include adults (age ≥ 18 years) who are capable of giving informed 
consent. Children, pregnant women and prisoners will be excluded.  
4.4. We will include English and Spanish speaking populations only, as our primary outcome 
measures have not been validated in other languages. We are excluding men as we are a 
Urogynecology practice and therefore do not treat that population.  
4.4.1. Because we are excluding pregnant women, during participant recruitment women will be 
asked if they are pregnant or have plans to become pregnant in the next 3 months. Their 
sexual activity, menopause status and surgical history (specifically hysterectomy or tubal 
ligation) will also be determined, which are standard questions asked in our practice for new 
patients.  If there is concern for pregnancy, we will perform a urine pregnancy test of the 
participant on the day of enrollment.  
5. Number of Subjects 
5.1. This is a single-center study at the University of New Mexico, therefore the total number of 
subjects at the University of New Mexico is the total number of subjects for the study.  
5.2. The total number of subjects to be recruited at this site is up to 130 patients.  
5.3. Sample size calculation: The primary outcome for this study is the change in the OAB-q 
total score from baseline to 3 months. We used the means and standard deviation for this 
questionnaire from an unpublished pilot RCT study from Walter Reed that compares PTNS 
and TENS for the treatment of OAB (unpublished work). We have powered the study based 
on a 10-point difference as significant between groups. This 10-point difference used for the 
power calculation is based on the previously established minimum important difference28.  
To achieve power for this non-inferiority RCT study showing that the difference between 
groups is less than 10 points, we need 40 patients per group (80 total) to detect no difference 
with alpha = 0.05 and 80% power. Allowing for dropout of up to 30%, we will aim to 
randomize 114 patients, and will plan to recruit up to 130 to allow for potentially higher 
drop-out, as the study primary outcome is at the 12 weeks’ time point.  As we plan to 
perform both per-protocol and intention-to-treat analysis, the sample size must be met for 
both per-protocol and intention-to-treat analysis, with the per-protocol patients (those in the 
PTNS group completing at 12 treatments in a total of 13 weeks) being expected to be a 
lower sample size. 

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6. Study Timelines 
6.1. Based on the current clinic volume in the UNM division of Urogynecology, we estimate 
recruitment up to 130 patients will be feasible over 2 years. A review of our clinic calendar 
revealed in 1 months’ time, the urogynecology division typically sees 10-20 patients who 
would meet criteria for our study. Assuming 25% enrollment (due to time commitment and 
eligibility criteria), we will be able to recruit our projected number of patients in less than 2 
years.  Participants will be followed for 3 months after randomization, so we expect an 
additional 3 months will be needed to collect follow up data. We estimate that data analysis 
and composition of the manuscript will take an additional 6 months.  
7. Study Endpoints:  
7.1. The primary endpoint of our study is to determine the change in OAB-q score in patients 
who undergo 12 weeks of PTNS compared to those who undergo TENS therapy for OAB. 
Our secondary endpoints include change in OAB-q Symptom Bother subscale score from 
baseline, change in OAB-q HRQL subscale score from baseline, number or urinary 
incontinence episodes, number of voids per day, number of voids per night, patient 
satisfaction question (PSQ) and patient compliance.  
7.2. Due to the extremely low risk of the therapeutic interventions, we do not have any safety 
endpoints. 
7.3. Our exploratory endpoints are to investigate compliance with treatment between groups 
and preference between therapeutic options.  
8. Research Setting 
8.1. The study will be performed at the University of New Mexico (UNM) Eubank Women’s 
Primary Care Clinic and Sandoval Regional Medical Center (SRMC) Urogynecology 
clinics. These Urogynecology clinics are dedicated to care of women with pelvic floor 
disorders such OAB, the target population for this study. 
8.2. Potential subjects will be recruited in the UNM Eubank and SRMC clinics when they 
present for care for OAB/UUI, either in person or virtually via telephone or Zoom care 
visits. All patients will have a history and physical taken to determine their study eligibility. 
Recruitment will take place either in private exam rooms at these clinics or over HIPAA-
compliant telephone or Zoom conversation. After recruitment, they will undergo the 
informed consent via the same means as recruitment and complete initial questionnaires in 
clinic or will be sent a copy (digital or mail) to complete if enrolled virtually.  Patients in the 
TENS group will be given their TENS device in clinic and research staff will assist in 
educating participants on proper placement and use of the device, as well as provide a 
standardized treatment protocol they will complete at home. The patients randomized to 
PTNS will have their sessions at the UNM Eubank Women’s Primary Care Clinic.  
8.3. There are no other laboratory tests in this trial beyond what would routinely be collected in 
the work up of OAB.  
8.4.  There will not be involvement of any community advisory board. 
8.5. There will not be any research conducted outside of the UNM HSC and its affiliates.  

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9. Resources Available 
9.1. Qualifications of PI and study staff:  Dr. Kate Meriwether is a board-certified subspecialist 
in Urogynecology and will serve as the primary investigator (PI) for this study.  She is an 
experienced researcher at UNM and eligible PI at UNM, in addition to serving on an HRRC 
at the UNM HSC Institutional Review Board, which makes her familiar with ethical and 
compliant practices.  She has been the PI on multiple research trials and has successfully 
completed randomized control trials both as a fellow and now as faculty at UNM. Dr. Sarah 
Jeney, a co-investigator on this project, is a board-certified in Obstetrics and Gynecology 
and is board-eligible for Urogynecology, as she recently completed her fellowship. She is an 
experienced researcher who has completed multiple research projects in Urogynecology, 
including a randomized control trial, as a resident and fellow. She recently joined as faculty 
at UNM. Dr. Angela Dao, a co-investigator on this project, is the fellow who has a total of 
12 months of protected research time during her fellowship in order to complete this study.  
9.2.  This trial does not require any medical decision-making or ordering of therapeutics due to 
research protocols. 
9.3. Resources available to conduct the research:  The University of New Mexico (UNM) 
Urogynecology division operates at two main locations. UNM Eubank Urogynecology 
Clinic, located in Northeast Albuquerque, provides a full range of services for women with 
pelvic floor disorders. The Eubank clinic consists of 8 examination rooms, 2 treatment 
rooms, and 2 physical therapy rooms. Our second location is at Sandoval Regional Medical 
Center (SRMC), a community-based facility located in Rio Rancho, New Mexico, a large 
suburb located outside of Albuquerque.   
Research Staff: The Urogynecology Division employs a clinical research specialist 
as well as research coordinators. Our research staff has extensive experience 
conducting multi-center investigations and recruiting patients to clinical studies, with 
special expertise in community-based research and quality of life studies. 
 
Research Experience: The Urogynecology Division at UNM has a strong history of 
conducting high quality research and collaboration with other investigators in the US 
and abroad, and has consistently met or exceeded recruitment goals on time. We 
have been members of the NICHD-sponsored Pelvic Floor Disorders Network 
(PFDN), and have met recruitment goals with high rates of follow-up and accurate 
data collection. In addition to PFDN research, Dr. Kate Meriwether has mentored 
and has been the PI on multiple clinical trials and contributes multiple publications in 
peer-reviewed journals. Her Curriculum Vitae is attached.  
 
Our group is well versed in the importance of adherence to protocols, timely 
completion of regulatory requirements, effective recruitment strategies, and the 
importance of the inclusion of minority subjects. Research is integral to all aspects of 
Divisional work; importantly, all members of the clinical team participate in research 
efforts.  There are weekly research meetings to discuss the progress of the ongoing 
studies within the department, and it is an excellent forum to ensure that all involved 
are adequately informed of their duties, of the protocol, and of the procedures.  

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We do not anticipate that emergency care will be needed for this study, as the interventions 
are low-risk.  However, the urogynecology physicians are available on a 24 hour basis, 7 
days per week for their patients requiring emergency care for any reason, including those 
relating to study participation. 
10. Prior Approvals 
10.1. There will not be any approvals obtained prior to commencing the research. The study was 
presented to Dr. Yuko Komesu for approval, and the signed Departmental Review Form can 
be found in the “Supporting Documents” section.  
10.2. This study does not include any ionizing radiation, biological specimens, or drugs. 
11. Multi-Site Research 
This is not a multi-site research study. 
12. Procedures  
This non-blinded, non-inferiority randomized controlled trial will be conducted at the UNM 
Eubank Clinic and SRMC Urogynecology clinic. Each site will recruit participants and we 
will plan to obtain up to 130 women between the two sites. Collaborating investigators will 
be members of the Urogynecology Division at UNM HSC.  
The primary aim of our study is to determine if symptoms and quality of life related to 
overactive bladder are improved similarly with TENS use versus PTNS in women with 
OAB/UUI. The target population will be patients with OAB or UUI who are seeking care 
after failing first- and second-line therapies. According to the American Urologic 
Association, first line therapy includes conservative treatments like bladder training, 
bladder-control strategies, pelvic floor muscle training or fluid management. Second-line 
treatment includes pharmacologic management with anti-muscarinic and β3-adrenoceptor 
agonist medications6,29. Subjects must have failed a trial of at least one medication (use with 
no improvement in symptoms for at least 8 weeks, or a contraindication to taking 
medication such as narrow angle glaucoma, use of other medications that would interact 
with anticholinergics, uncontrolled hypertension, allergic reaction or adverse side effect to 
an anticholinergic medication).  The subject may have stress urinary incontinence, but 
urinary urgency or urgency urinary incontinence must be a bothersome complaint or 
symptom. The current standard-of-care recommendation for those with refractory OAB or 
UUI who have failed first- and second-line therapies is to offer patients third-line treatment 
with PTNS, sacral neuromodulation, or intradetrusor injection of onabotulinumtoxinA6,29. 
For patients who present for treatment of refractory OAB or UUI, we will take a thorough 
history and physical and counsel the patient on all of her options including medical and 
surgical interventions.  
 
If the patient is interested in non-surgical management with PTNS and fulfills study 
inclusion criteria, we will then offer her the choice of volunteering for the study. All women 
will give written and/or electronic consent prior to their enrollment at this time and fill out 
baseline questionnaires in the clinic. Research staff and clinicians will obtain consent and 
administer study. After enrollment, participants will fill out a baseline OAB-q and will be 

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given a 3-day voiding diary to complete prior to starting their intervention. Urinalysis and 
urine culture will be obtained to rule out urinary tract infection. This is routinely done on all 
new patients in our clinic and would be performed on patients not participating in the study 
as well.  Data collected in addition to the above outcome measures includes patient 
demographics, medical/surgical history, and contact information, which are attached as 
supporting documents. This information will be collected from the patient on the day of 
enrollment and we will review the patient’s medical record if information is missing or 
unclear.  
 
The randomization sequence will be generated by computer-based randomization in a 
sequence that preserves 1:1 randomization and also preserves allocation concealment (likely 
with randomly alternating block sizes of 6-10 in blocked randomization). Randomization 
assignments will be completed via REDCAP by a research coordinator. Randomization will 
only occur after consent has been signed and all baseline data has been obtained.  
 
12.1. Interventions: 
 
12.1.1. PTNS: Women randomized to the PTNS group will begin therapy after their baseline 
evaluation is complete. They will be scheduled for PTNS treatment sessions once weekly 
for 30 minutes, for 12 weeks total. PTNS treatment will be performed as follows: 
- 
The patient sits in a reclining chair, with their legs elevated on a foot rest. The 
area for needle placement is cleaned with an alcohol swab. A 34 gauge needle is 
inserted percutaneously approximately 5 cm cephalad to the medial malleolus of 
the right or left ankle (patient’s choice) at a 60 degree angle. A surface electrode 
is placed on the medial aspect of the ipsilateral calcaneus. The needle and 
electrode are connected to a low voltage (9V) electrical stimulator (brand name). 
Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 µsec 
is increased until flexion of the big toe or fanning of all toes visualized, or until 
the woman reports a tingling sensation across the heel or sole of the foot. The 
current is then set to the highest level of tolerable to the patient (0-10 mA) and 
then she undergoes therapy for 30 minutes. If no response is seen (no fanning of 
toes or flexion of big toe or no report of a tingling sensation across the heel or 
bottom of the foot), the needle is replaced on the same or opposite side until the 
appropriate response is seen.  The needle placement sites will be monitored for 
bleeding, bruising, irritation or a hematoma.  This will be repeated each week, 
until the completion of 12 weeks of treatment.  
- 
If women assigned to the PTNS arm miss one of their weekly office PTNS 
sessions, they will be permitted to “make up” the missed session at the end of the 
12 weeks, and their “12 week” outcome measures will be performed following 
that last session (13 weeks following randomization).  Women that have missed 
this one session and made up the session at the end of the treatment course will be 
considered “fully compliant” with treatment and analyzed in the “per protocol” 
analysis as having completed the PTNS treatment course per protocol. 
- 
If women assigned to the PTNS arm miss more than one of their weekly office 
PTNS sessions, they will not be allowed to make up the extra sessions and their 

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participation in the study or outcome measurement will not be extended further 
than 13 weeks after randomization.  However, they will not be withdrawn from 
the study for missing sessions, and will be followed for outcomes and adverse 
events despite missing sessions of PTNS.  Women that miss more than one 
session of PTNS or miss one session and do not make it up at the end will be 
considered “not fully compliant” with PTNS treatment, and will be analyzed in 
the “intention-to-treat” analysis in the PTNS arm but not in the “per protocol” 
analysis in the PTNS arm. 
Prior to their week 6 session, women will be asked to complete a 3-day voiding diary in 
the three days before their scheduled PTNS treatment and bring it to clinic.  At their 
week 6 session, women will complete the UDI and PSQ questionnaires via REDCAP on 
an iPad in clinic. The same will be conducted for their week 12 session. Patient 
compliance of attending PTNS sessions will be recorded.  
 
12.1.2. TENS: Women randomized to the TENS groups will begin therapy after their baseline 
evaluation is complete. They will be asked to purchase a TENS 7000 device (estimated 
cost $30) and will administer self-treatment at home, daily for 20 minutes, for 12 weeks 
total. Current practice in the Urogynecology clinic is to offer TENS therapy to women as 
an alternative to in-person maintenance therapy for after completing PTNS 12 sessions. 
TENS 7000 device is off label for its use in the treatment of OAB. If funding is secured, 
women in both PTNS and TENS group will be reimbursed with a merchandise card. 
Participants will be asked to bring their device to clinic to the ensure the correct device 
is used, standardize settings and provide the following patient education:  
- 
Proper TENS device set up and pre-set standardized settings, detailed below 
- 
Proper electrode pad placement that will be demonstrated. Electrodes will be 
traced with a skin marker during this clinic visit and pictures will be provided to 
ensure correct placement at home. If the patient has a camera, they can 
photograph electrode placement while in clinic.   
- 
Determine intensity level 
- 
Patients will be notified that they can go about their regular daily activities with 
the TENS device in place, so that treatment does not interfere with normal work 
or household duties. However, they will be instructed to not use the device while 
exercising due to sweat causing reduced adhesive function of electrodes and 
possible displacement. 
- 
If a caretaker will be assisting the participant in use of the TENS unit due to 
physical limitations, they too will be instructed in set-up and use. 
- 
An information handout with device settings, surface electrode placement, and 
treatment schedule will be provided at this initial clinic visit.  
TENS treatment will be performed as follows (adapted from the most common setting 
from a s systematic review of TENS for OAB)25: 
- 
Surface electrodes, 2 x 2 in diameter, will be placed 5 cm cephalad to the medial 
malleolus of the right or left ankle (patient’s choice). The second surface 
electrode is placed on the medial aspect of the ipsilateral calcaneus. The 
electrodes are connected to the TENS device with the following pre-set settings: 
- 
Mode: “M” or modulation  

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- 
Frequency: 10 Hz 
- 
Pulse width: 200 µsec 
- 
Intensity: to patient comfort level, as determined at clinic visit when device is 
verified. This is variable and participants will be told that as they use the device 
regularly, it is anticipated that they will become accustomed to stimulation and 
may need to change this setting.  
- 
Women will then complete 20-minute daily TENS treatment using the settings 
above, for 12 weeks total. 
- 
If women assigned to the TENS arm miss more than 2 daily sessions in a week on 
one of their weeks of treatment, they will be permitted to “make up” the missed 
sessions with an extra week of treatment at the end of the 12 weeks, and their “12 
week” outcome measures will be performed following that week of make-up (13 
weeks following randomization).  Women that had this one “deficient week” with 
less than 5 treatments in a week and made up a week (with 5 or more daily 
treatments in the last week), their treatment course will be considered “fully 
compliant” with treatment and analyzed in the “per protocol” analysis as having 
completed the TENS treatment course per protocol. 
- 
If women assigned to the TENS arm miss more than 2 days a week averaged over 
the course of the study thus far, they will not be allowed to make up the extra 
sessions and their participation in the study or outcome measurement will not be 
extended further than 13 weeks after randomization.  However, they will not be 
withdrawn from the study for at-home TENS, and will be followed for outcomes 
and adverse events despite missing sessions of at-home TENS.  Women that miss 
more than 2 daily sessions a week of TENS, as averaged over the 12 weeks, will 
be considered “not fully compliant” with TENS treatment, and will be analyzed in 
the “intention-to-treat” analysis in the TENS arm but not in the “per protocol” 
analysis in the PTNS arm. 
Participants in the TENS group will receive weekly phone or email reminders to 
complete treatment program and inquire about any adverse effects. During their week 6 
of treatment, women will be contacted by telephone to check concordance with 
treatment program, discuss any issues and ask them to complete a 3-day voiding diary, 
UDI and PSQ questionnaires via REDCAP. A log to track TENS use will be provided 
to participants. They will be able to access this via REDCAP. The same will be 
conducted at the end of week 12.  
 
Table 1: Outcomes collected at various time points 
 
Baseline 
6 weeks 
12 weeks  
Demographic and medical history  
X 
 
 
OAB-q 
X 
X 
X 
3 day voiding diary 
X 
X 
X 
PSQ 
 
X 
X 
Number of treatment sessions 
completed 
 
X 
X 
 
12.2 Outcome measures: 

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12.2.1 OAB-q: The Overactive Bladder questionnaire is a validated tool to assess the patient’s 
perceptions of symptom bother and impart on HRQL among patients with both continent 
and incontinent OAB. It is comprised of 8 symptom bother questions and 25 HRQL 
questions that form 4 subscales (coping, concern, sleep, and social interaction) and a total 
HRQL score. OAB-q is widely utilized in OAB/UUI16,22,25,28,30–34.  
12.2.2 Voiding diary: This is a patient completed record of micturition behavior to obtain 
objective data on subjective symptoms. The International Continence Society (ICS) 
recommends use of voiding diaries in the clinical assessment of patients with lower 
urinary tract symptoms2. It is a chart where patients record their urinary habits for at least 
24 hours and is widely used in OAB/UUI2,21,23,27,30,35–39. 
12.2.3 PSQ: The Patient Satisfaction Question is a validated tool to assess patient satisfaction of 
treatment. It is comprised of a single question and is widely used in OAB/UUI30,40,41.  
 
13. Data Analysis 
13.1. Data Analysis: Between and within group differences will be evaluated using Fisher’s 
exact test for categorical variables and t-tests for continuous variables, as we expect the 
data will be normally distributed. Wilcoxon rank-sum test will be used for continuous 
variables that are not normally distributed.  If there are any baseline differences between 
groups, a multivariate analysis will determine the contribution of these differences to 
observed differences (if any) between groups. 
13.2. Intention-to-treat analysis:  We plan to perform the primary analysis as “intention-to-treat” 
indicating that patients will be analyzed in the group to which they were randomized, 
regardless of compliance with study procedures, unless they asked to be withdrawn or were 
withdrawn by investigators due to safety or validity concerns.  For example, PTNS patients 
that miss more than one session or do not make up a missed session of their office PTNS 
would still be analyzed in the “intention-to-treat” analysis as being in the PTNS group.   
13.3. Per protocol analysis:  We plan to perform a secondary analysis as “per protocol” 
indicating that patients will be analyzed in the group to which they were randomized only if 
they complete a full 12 weeks of treatment in compliance with study procedures, meaning 
that women assigned to the PTNS arm completed 12 weekly PTNS session in the office in 
13 weeks or less, and women in the at-home TENS arm performed TENS stimulation at 
least 5 days per week for 12 weeks, as averaged over 12 weeks.  For example, PTNS 
patients that miss more than one session or do not make up a missed session of their office 
PTNS will not be analyzed in the “per protocol” analysis as being in the PTNS group.   
13.4. Power Analysis: Power analysis was performed based on previously reported means and 
standard deviation for the OAB-q. The primary outcome of this study is improvement in 
HRQL and symptom bother of OAB/UUI as measured by the OAB-q. We used the means 
and standard deviation for this questionnaire from a prior unpublished pilot RCT from 
Walter Reed comparing PTNS and TENS for the treatment of OAB. We have assumed a 
change score of greater than 10 points to be significant between groups based on the 
minimally important difference that has been previously established28. To achieve 
significance for a non-inferiority study using these assumptions we would need 80 patients, 

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40 per group to detect this difference with alpha = 0.05 and 80% power. To allow for a 
dropout of up to 30% we will enroll up to 130 patients to account for participants who are 
lost to follow up.  As noted above, we plan to perform both per-protocol and intention-to-
treat analysis, and adequate power much be achieved for both per-protocol and intention-
to-treat analysis, with the per-protocol patients (those in the PTNS group completing at 12 
treatments in a total of 13 weeks) being expected to be a lower sample size and take more 
recruitment and study follow-up to achieve power. 
 
14. Provisions to Monitor the Data to Ensure the Safety of Subjects 
There is no DSMB that will be monitoring safety of these procedures as the study risks are 
low. PTNS is a common treatment modality for OAB and UUI and standard of care6,29 with 
minimal adverse effects16,18,19,21,36.  TENS for OAB and UUI has been shown to be a low-risk 
intervention with minimal adverse effects23–25,27,38,42,43. Skin irritation, a “shocking” 
sensation, or temporary pain with stimulation could be experienced. Additionally, we will 
keep track of adverse events by asking patients about adverse effects at each weekly 
treatment session for the PTNS group and in weekly phone or email reminders for the TENS 
group during the course of the study. Because neither of the studied treatments are 
experimental or associated with above average risk we do not anticipate any significant 
adverse events. Participants will have access to a 24/7 phone number to reach research or 
clinical staff with concerns. All adverse events will be recorded in REDCap and reported to 
the study PI.  
 
We do not anticipate any conditions that would trigger a suspension or termination of the 
research. 
 
15. Withdrawal of Subjects 
Participants may withdraw from the study at any time without penalty and will continue to 
receive the clinical standard of care. A subject may be withdrawn from the study without her 
consent at the discretion of the physician and study staff if they believe she no longer meets 
study inclusion criteria or if she meets exclusion criteria, if they believe that it is not in her 
best interest to continue study participation i.e., desire to undergo alternative treatment, or if 
they stop the study early due to scientific reasons. Investigators may withdraw a subject if the 
subject is not following the study protocol. If a woman is withdrawn from the study either at 
her own discretion or that of the research staff, she may continue with conservative or 
surgical management of her OAB/UUI in the usual fashion. If a participant chooses to 
withdraw from the study, the study intervention and PTNS device will no longer be provided 
to the participant and may not be available for purchase. If a participant withdraws from the 
TENS group, the TENS device they purchased will be kept by the participant. 
To minimize withdrawal from the study, patients will be randomized after they have had 
what they feel to have been adequate time to consider whether or not they would like to 
participate in the study and they provide consent. According to the 2010 CONSORT 
guidelines, we will analyze all participants assessed for eligibility within the study. We will 
document reasons for withdrawal from the study if the participant willingly provides this 

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information. We will report eligibility criteria not met or reasons for declining participation 
in the study if the participant willingly provides this information. The withdrawal procedure 
is clearly documented in the study consent. 
 
16. Data Management/Confidentiality 
Participants will be given a de-identified study subject number. Data collection sheets 
and questionnaires will contain the subject number. No other patient identifiers will 
be collected on study forms.  PHI including patient name, date of birth, phone 
number, email address and medical record number will be collected to track 
appointments and ensure patient follow-up. The data collection, HIPAA and consent 
forms will be maintained in a locked file cabinet in the locked Eubank research office 
or via REDCap. A separate folder will be designated for each participant. PHI will 
not be entered into the study database. The link between PHI and study IDs will be 
kept on a password protected computer on a secure UNM OBGYN department 
server.  
The study database does not include sensitive information or information requiring 
additional protection. 
 
Study binders will be kept in a locked cabinet in the research administrative area. In 
order to further ensure patient confidentiality, the identifying information will be kept 
separately from the numbered study files in a locked cabinet. 
Electronic data entry will be performed on REDCAP, using the de-identified subject 
study number.  The electronic data and subject link will be encrypted, password 
protected, and stored on the secure UNM OBGYN department server. This server’s 
electronic security is monitored / maintained by the Health Sciences Library and 
Informatics Center (HSLIC). A REDCAP database will be created to collect, store 
and manage the data. REDCAP databases are reposed securely and all data entered is 
de-identified. The REDCAP database is only accessible using an individual unique 
login and password and access is only provided to co-investigators.  Access is 
restricted to co-investigators and research staff and will be protected using the unique 
REDCAP login and password provided to each co-investigator. 
Access to the files and REDCAP will be restricted to research personnel and 
Investigators and will be locked or password-protected using the unique REDCAP 
login and password provided to each co-investigator. The data will be stored for 6 
years after completion of analysis and study closure and then will be destroyed. 
A Certificate of Confidentiality will not be used to protect data from forced release. No 
identifying or study related data will be transported to outside locations. There will be no 
audio or video recordings or photographs taken. 
17. Data and Specimen Banking 
As stated above, the data collection, HIPAA and consent forms will be maintained in 
a locked file cabinet in the Eubank research area. A separate file will be designated 

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for each participant. A key matching study number to subject’s name will be stored 
on a password protected computer on a secure UNM OBGYN department server. In 
order to further ensure patient confidentiality, the identifying information will be kept 
separately from the numbered study files in a locked cabinet. The data will be 
maintained for 6 years after completion of the study and then destroyed. 
18. Risks to Subjects 
Risks of enrollment in the study include loss of confidentiality. We will take every 
measure to try to ensure the security and confidentiality of participants. Participants 
will be recruited in a private room or in a private location via phone or HIPAA 
compliant ZOOM and will have ample time to consider whether they want to 
participate in the study. Also, locked cabinets will be used to protect patient consent 
information and collected data. The link identifying patients and their study numbers 
will be also stored on a password protected computer on a secure UNM OBGYN 
department server. 
Additionally, each patient who will be offered enrollment will already have agreed to 
non-surgical management of her OAB. There are minimal risks with being assigned 
to either study intervention in this RCT. PTNS could cause pain, bruising, tingling or 
bleeding at the insertion site,leg cramps, numbness/pain under the sole of the foot, 
generalized swelling, worsening of incontinence, generalized headache and vasovagal 
response to needle placement, but these are rare or occasional21,43. No serious adverse 
effects, like permanent or irreversible nerve damage or permanent or long-term loss 
of muscle function, have been reported for PTNS. TENS could cause temporary skin 
irritation, leg cramping or numbness/pain, however no adverse events, such as 
permanent or long term nerve damage or loss of muscle function, have been 
reported23,25,27. Emotional discomfort due to the reflective nature of the questionnaires 
or lack of symptom improvement is also possible. Both treatment randomizations in 
this study are well established as options for OAB with an excellent safety profile. 
Participants may also have to pay for the cost of transport to clinic visits and data 
charges for mobile devices for phones call or ZOOM visits.  
Pregnant women will not be included in the study, so there is no risk to 
embryos/fetuses. If there is concern for pregnancy, we will test the participant on the 
day of enrollment. If they are pregnant, the patient meets exclusion criteria and will 
be ineligible to participate.  
There are no risks to those who are not subjects. 
19. Potential Benefits to Subjects 
The patients enrolled are already opting for third line, non-surgical treatment of their OAB. 
Participation in this study may help to improve an individual participant’s condition, but it is 
also possible that the condition may not improve. There is no guarantee that any individual 
will personally benefit by participating in this research study. Women randomized to TENS 

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will potentially get benefit from having a personal device they can keep and use on their own 
time. Women randomized to TENS will not require weekly in-person office visits, which will 
save time on travel, office visits, and potential COVID-19 or other viral exposures as 
compared to the PTNS group. Participation in this study may provide information that may 
help other people who have a similar medical problem in the future. The literature supports 
improvement of QOL with improved OAB symptoms. PTNS and TENS have both been 
successfully used to treat OAB and UUI in the past.  
20. Recruitment Methods 
The Urogynecology clinics at UNM Eubank, and SRMC have a large referral 
population of patients with pelvic floor conditions such as OAB. Subjects will be 
identified in the clinics at UNM Eubank clinic and SRMC by investigators when they 
present either in person or virtually (telephone or Zoom visits) for visits for OAB 
care. The patients will be counseled about possible treatment options for OAB and 
they will be introduced to the study and provided with written information that may 
help them decide if participation in the study is right for them. Subjects are 
encouraged to consult with family, friends, and primary health care providers, as well 
as communicate any questions they may have before beginning the consent process. 
We will request a waiver of HIPAA authorization for recruitment purposes.   
If a woman declines to participate or is withdrawn from the study either by her desire 
or that of the research staff, she will be offered the same treatment options. Her 
follow up appointments will be the same regardless of participation in the study. 
Potential participants may also self-identify through a recruitment material flyer that will be 
placed in Eubank clinic restrooms, waiting area and in the OB/GYN department at UNM. 
The proposed recruitment flyer is uploaded in the supplemental materials section.  
21. Provisions to Protect the Privacy Interests of Subjects 
Privacy concerns are considered with every patient seen at the UNM and SRMC 
clinics. Participants approached and/or interviewed in the clinic setting will be in 
either private offices or examination rooms in the clinics, personal Zoom or on 
telephone calls that are HIPAA compliant. All staff, including research staff, are well-
versed in sensitive health care discussions and procedures. Telephone interviews for 
recruitment and study data gathering are conducted in the research staff area or 
private physician offices, where all staff have received CITI Training.  The office 
area designated for the entire Urogynecology research staff is isolated from the 
clinical administrative staff area, providing protection for participants and potential 
participants during screening, recruitment, study-designated calls, and data entry. All 
study sheets used to collect patient information will be de-identified.  
At all times throughout the clinical investigation, confidentiality will be observed by all 
parties involved. All data will be secured against unauthorized access. Privacy and 
confidentiality of information about each subject will be preserved in study reports and in 
any publication. Each subject participating in this study will be assigned a unique identifier. 
An IRB-approved HIPAA authorization within the consent is required to be given to the 

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patient. All documents containing personal health information (screening logs, consent 
documents, data forms) are maintained in locked cabinets with access available only to 
research staff and investigators. Data is entered into a password protected system. No 
individual identifiers, other than email to send consent and questionnaire forms, are entered 
into the system. The sole link with personal information is maintained by the research team 
on a password protected computer on a secure UNM OBGYN department server with access 
limited to authorized research staff and investigators. This information is only to be used at 
the study center. 
22. Economic Burden to Subjects 
The cost of the TENS 7000 device and associated materials will be the responsibility of the 
subject if randomized to the TENS group. If funds become available, we will plan to 
compensate participants in both the PTNS and TENS arms with a $50 merchandise card. 
Participants will not be billed for any other study materials. 
 
Participants have already chosen to undergo third line, non-surgical treatment of their 
OAB/UUI and will receive prior authorization from their third-party payers if randomized to 
PTNS or will have worked out financial assistance if needed. These costs will be billed to 
their insurance provided and costs may range from copay only to full cost of treatment. 
 
Research Procedures 
Number of 
Samples/Procedures 
Responsible Party 
Study 
3rd Party Payer 
or Participant 
TENS Device 
1 
☐ 
☒ 
      
      
☐ 
☐ 
Standard of Care Procedures 
Number of 
Samples/Procedures 
Responsible Party 
Study 
3rd Party Payer 
or Participant 
PTNS Treatment 
12 
☐ 
☒ 
Clinic visit 
1-2 
☐ 
☒ 
Transportation to PTNS treatment 
0-12 
☐ 
☒ 
Transportation to Clinic Visits 
1-2 
☐ 
☒ 
Phone Visit – remote 
2 
☐ 
☒ 
      
      
☐ 
☐ 
      
      
☐ 
☐ 
      
      
☐ 
☐ 
 
23. Compensation 
At this time, no compensation will be provided to study participants. If funds become 
available, each participant will be compensated with a merchandise cards worth $50: a $25 
merchandise card when they complete 6 weeks of treatment (6 weekly sessions in the case 
of the PTNS group) and another $25 merchandise card when they complete 12 weeks of 
treatment (12 weekly sessions in the case of the PTNS group).  These compensations will be 

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provided to patients when they complete 6 sessions or 12 sessions and the resulting 
outcomes measures, regardless of when they complete them. So, for example, if a PTNS 
patient does 6 sessions of PTNS in an 8-week period, they will get the $25 merchandise card 
when they complete the 6 sessions (after 8 weeks).  A modification will also be submitted to 
the IRB to update the protocol and consent with compensation amounts.  This payment will 
be reasonable compensation for the purchase of a TENS device and the inconvenience of 
participating in a research study due to the additional time the study questionnaires will 
require from the participant.  
24. Compensation for Research-Related Injury 
If participants are injured or become sick as a result of this study, which is extremely 
unlikely given the nature of the interventions, UNMHSC will provide emergency treatment 
at the study participant’s cost. No commitment is made by the University of New Mexico 
Health Sciences Center to provide free medical care or money for injuries to participants of 
the study. Reimbursement for treatment for all related costs of care will be sought from the 
participant insurer, managed care plan, or other benefits program. The participant will be 
responsible for any associated co-payments or deductibles required by the insurance. 
Participants will be encouraged to report any illness or injury they believe to be related to 
the study to the investigator or research staff. Participants will be given telephone contact 
information for the Urogynecology office for the purpose of asking any questions or stating 
any concerns about the study or treatment as a research subject. They may also be directed 
toward the HRPO. This language will be stated in the consent document, and reviewed 
during the informed consent process. 
25. Consent Process 
Patients will be approached about the research study at the Urogynecology clinic or 
via virtual consultation at UNM Eubank or SRMC during a discussion for the 
management of OAB/UUI. Each patient undergoes counseling in a private room 
with a closed door to ensure privacy. The physicians in the Urogynecology division 
and research staff will be able to give a paper or electronic consent to patients to 
allow for inclusion. REDCap will be utilized to eConsent participants with the 
HRRC approved PDF consent uploaded into REDCap. Our division routinely treats 
this condition and are highly qualified to counsel patients regarding the risks, 
benefits, alternatives for the treatment. Care will not be withheld if they decide not to 
participate. If the patient prefers, she may also be counseled about study 
participation via ZOOM or phone following her clinic appointment by providers or 
study personnel.  
The patients who would like to participate in the study will be consented during their 
new or return visit in the Urogynecology clinic. Participants will have these multiple 
opportunities to ask any questions and they will also be provided with the clinic’s 
contact information to get in touch with research investigators to address any 
additional questions or concerns.  

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Subjects will be reassured that participation is completely voluntary and does not 
affect their treatment, their relationship with their providers, or the university to 
minimize the possibility of coercion or undue influence.  The patients will be asked 
that they understand the opportunity to participate and their complete freedom to 
decline.  This will also be asked if they understand and if they have any questions.  
There is no minimum time period needed between informing the patient of the study 
and time of consent.  Subjects will be encouraged to take as much time as they need.  
This study will obtain HIPAA authorization prior to enrollment. HIPAA 
authorization will be reviewed with all participants by the physician or research staff 
obtaining consent. Specific information that will be obtained includes prior medical 
history, surgical history, reproductive health history including child bearing, drug 
allergies, age, and ethnicity. This information will be obtained by health care 
providers, not research coordinators, as deemed necessary for a more complete and 
accurate medical history of the patient. 
Subjects not fluent in English: 
Patients will be consented with a certified translator if Spanish speaking. Spanish-
speaking patients will be offered information about risks, benefits, and alternatives 
to study participation in a private setting and given adequate time to consider the 
risks and benefits of the study prior to offering consent or declining to participate.  
The Spanish consent will be translated from the English consent once the English 
consent is approved, and we will submit a modification in Huron IRB to update the 
study with Spanish materials in the future. 
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally Authorized 
Representative: 
NA. Cognitively impaired subjects will not be included in this study. 
Subjects who are not yet adults (infants, children, teenagers): 
NA. Only subjects ≥ 18 years of age will be included in this study.  
Waiver or Alteration of Consent Process (consent will not be obtained, required 
element of consent will not be included, or one or more required elements of consent 
will be altered)  
NA. There will be no waiver or alteration of the consent process. 
26. Documentation of Consent 
26.1. We plan to document consent and the consent form is attached.  
26.2. We do not plan on collecting or storing tissue samples. 

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27. Study Test Results/Incidental Findings 
We do not anticipate that the research being conducted will result in incidental findings. 
Every patient will receive the practice’s standard of care regarding workup of OAB, which 
may include different laboratory tests, urine culture or urodynamic testing if unclear cause 
of incontinence, or imaging studies, as determined by their other active medical issues. 
These results are not directly a part of the research being conducted and will hence be 
disclosed to the patient. They will not, however, affect randomization. 
 
28. Sharing Study Progress or Results with Subjects 
We do not intend to share study progress with participants while the study is underway as 
not to introduce bias. We do not intend to seek out study participants to disseminate 
information once the study is complete. Women who are interested in the results will be 
provided the information where to read the manuscript once it is published. Study results for 
individual participants will not be shared.   
 
29. Inclusion of Vulnerable Populations 
NA. There will not be any vulnerable populations included in this study. 
30. Community-Based Participatory Research 
NA. There will be no involvement of the community in this research.  
31. Research Involving American Indian/Native Populations 
NA. This research does not specifically target this population. If an American Indian woman 
is a candidate for the study, she will be offered participation if she is able to 
speak/read/write in English or Spanish. 
32. Transnational Research 
NA. This study is domestic. 
33. Drugs or Devices 
The devices used in this study are considered standard of care for the use and treatment of 
OAB. Urgent PC® Neuromodulation Device made by Uroplasty was FDA approved for use 
10/17/2005 with the updated leads and device approved 10/21/2010 (see FDA website 
https://www.accessdata.fda.gov/cdrh_docs /pdf10/K101847.pdf). The PTNS device is stored 
at the UNM Eubank Urogynecology clinic and only handled and administered by trained 
healthcare providers. TENS 7000® device made by Roscoe Medical was approved by the 
FDA on 03/24/2008 for use for pain therapy(See FDA website https://www.accessdata. 
fda.gov/cdrh_docs/pdf8/K080661.pdf). The TENS system is available over the counter 
(FDA 501(k) Summary provided in Supplemental documents) and routinely used for 
overactive bladder therapy, but is considered an off-label use. Recently, a TENS device 
specifically marketed for treatment of OAB was FDA cleared as Substantially Equivalent on 
03/19/2021 (see FDA website 
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192731.pdf). However, the device is not 

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currently available for purchase, therefore we will use the TENS device described above. 
Participants will be educated on its use, storage and maintenance at their clinic visit. 
34. Principal Investigator’s Assurance 
By submitting this study in the Huron IRB system, the principal investigator of this study confirms 
that: 
☒ The information supplied in this form and attachments are complete and correct.   
☒ The PI has read the Investigator’s Manual and will conduct this research in accordance with these 
requirements.  
☒ Data will be collected, maintained and archived or destroyed per HSC Data Security Best 
Practices, including: 
1. Best Practice for data collection is to be directly entered onto a data collection form that 
is stored in a secured access folder on HSC central IT managed network storage (such as 
the N:\Research-Studies drive), or in a secure HSC Information Security approved system 
such as REDCap. 
2. Temporary storage -- de-identified data collection, if done in a clinical setting or other 
setting that does not allow direct entry into a secured system, may be temporarily stored 
using encrypted removable (e.g. CD-ROM (a compact disc used as a read-only optical 
memory device for a computer system), USB flash/thumb drive (a small external flash 
drive that can be used with any computer that has a USB port), etc.) media or a university 
owned electronic storage device or hard copy document. This temporarily stored data 
must be transferred to HSC central IT managed network storage and deleted from the 
temporary device as soon as possible.  The important security safeguard is that no 
identifiers be included if the data is entered or stored using a storage container that 
is not managed by HSC central IT. 
3. Permanent (during data analysis, after study closure) storage must reside on HSC 
central IT managed network storage (such as the N:\Research-Studies Drive). Processing 
of data (aggregation, etc.) are to be carried out in such a way as to avoid 
creating/retaining files on untrusted or unsecure storage devices/computers (an example 
of an unapproved storage location would be storing the data locally on your HSC 
computer hard drive rather than on the HSC network drives). Trusted devices are HSC 
managed and provide one or more of following safeguards: access logs, encryption keys, 
backups, business continuity and disaster recovery capabilities. 
4. Alternate storage media must be approved by HSC IT Security as meeting or exceeding 
HSC central IT provided security safeguards. 
 
35. CHECKLIST SECTION 
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB.  Please complete all checklists relevant to your research. 
36. Partial Waiver of Consent for Screening/Recruitment 
NA. We are not requesting a partial waiver of consent for screening/recruitment.  

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37. Partial Waiver of HIPAA Authorization for Screening/Recruitment 
We are requesting a partial waiver of HIPAA authorization for screening/recruitment.  
A. Will you be recording any PHI when conducting the records review to identify potential 
subjects and/or determine eligibility? 
            ☒ Yes. Describe: We will review medical records of participants to ensure they are 
eligible for the study. In particular, we will confirm if they have a diagnosis of OAB 
or UUI and ensure they do not have an alternative diagnosis that would make them 
ineligible.  
            ☐ No 
B. If you answered “Yes” to question 6 above, please describe when you will destroy 
identifiers (must be the earliest opportunity consistent with the conduct of the research) 
or provide justification for why they must be retained: 
If women are enrolled in the study after recruitment and informed consent, 
their PHI will be maintained in a locked file cabinet in the locked Eubank 
research office, in a separate folder designated for each participant. PHI will 
not be entered into the study database. The data will be stored for 5 years after 
completion of analysis and then will be destroyed. 
If women are not enrolled, PHI collected for the purpose of screening and 
recruitment will be immediately destroyed.  
C. The PHI accessed or recorded for identification/screening purposes will not be reused or 
disclosed to (shared with) any other person or entity, except as required by law, for 
authorized oversight of the research study, or for other research for which the use or 
disclosure of the PHI would be permitted under the Privacy Rule. 
 
      ☒ True 
            ☐ False 
38. Waiver of Documentation of Consent 
NA. We are not requesting a waiver of documentation of consent 
 
39. Alteration of Consent 
NA. We are not requesting an alteration of consent. 
40. Full Waiver of Consent/Parental Permission 
NA. We are not requesting a full waiver of consent/parental permission. 
41. Full Waiver of Consent/Parental Permission (Public Benefit or Service 
Programs) 

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NA. We are not requesting a full waiver of consent/parental permission. 
 
42. Full Waiver of HIPAA Authorization (Checklist) 
NA. We are not requesting a full waiver of HIPAA authorization. 
 
43. Other Waiver Types (Checklist) 
NA. We are not requesting other waiver types.  
 
44. Vulnerable Populations (Checklist) 
 
A. Adults with Cognitive Impairments 
NA. Adults with cognitive impairments will not be included in this study.  
B. Children 
NA. Children will not be included in this study.  
C. Pregnant Women and Fetuses 
NA. Pregnant women and fetuses will not be included in this study.  
D. Neonates of Uncertain Viability or Nonviable Neonates 
NA. Neonates of uncertain viability and nonviable neonates will not be included in 
this study.  
E. Nonviable Neonates 
NA. Nonviable neonates will not be included in this study.  
F. Biomedical and Behavioral Research Involving Prisoners 
NA. Prisoners will not be included in this study.  
 
45. Medical Devices (Checklist)  
Complete this checklist if the research evaluates the safety or effectiveness of a medical device.  
If more than one medical device is being evaluated, provide the requested information for each. 
A. Device Name:  TENS 7000 
B. Manufacturer:  Roscoe Medical 
C. Does the research involve a Significant Risk Device under an IDE? 
☐Yes. Include documentation of the FDA approval of the IDE with your submission.  
Acceptable methods of documentation include: (1) FDA letter noting IDE number 
and approval status; (2) Industry sponsor letter noting IDE number and FDA 

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approval status; or (3) FDA-approved industry sponsor protocol with IDE number 
noted  
☒No 
D. Is the research IDE-exempt? 
☐Yes. Include a FDA letter with your submission noting the determination that the 
research is IDE-exempt or a letter from the sponsor (or sponsor-investigator) 
justifying why they believe the research is IDE-exempt*.   
☒No 
E. Does the research involve a Non-Significant Risk (NSR) Device? 
☒Yes. Include a FDA letter with your submission noting the determination that the 
research is NSR or a letter from the sponsor (or sponsor-investigator) justifying why 
they believe the research is NSR**.   
☐No 
* This FDA guidance includes a description for when a device study is exempt from the 
IDE requirements: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf  
**This FDA guidance includes information on how to differentiate between Significant 
Risk and Non-Significant Risk device studies: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf  
46. Export Control (Checklist) 
NA. There will not be any export control concerns.  
47. Data Transfer/Sharing/Storage (Checklist) (required –do not delete even if 
the answer is “No”)  
Data Use Agreement (DUA) Contacts:  
Sponsored Projects Office  
• Aida Andujo, Manager, AAndujo@salud.unm.edu 
• Siiri Wilson, Contract Specialist, SiWilson@salud.unm.edu 
Privacy Office  
• Laura Putz, Privacy Officer, LPutz@salud.unm.edu 
• Gayle Shipp, Privacy Specialist, GShipp@salud.unm.edu 
Information Security Office 
• Information Security Office, HSC-ISO@salud.unm.edu 
 

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Provide all information requested if the research involves transferring/sharing of data with an 
external entity (institution, company, etc.).  
A. Will UNM data be transferred/shared with an external entity (i.e. another institution, 
company, etc.) or will an external entity’s data be transferred/shared with UNM?   
☐Yes. If yes, all questions must be answered congruently based on protocol 
provisions. 
☒ No. If no, the remainder of this section does not apply.  
 
48. Specimen Transfer/Sharing (Checklist) (required –do not delete even if the 
answer is “No”) 
Provide all requested information if the research involves transferring/sharing of specimens with 
an external entity (institution, company, etc.).  
A. Will specimens be transferred/shared with an external entity (institution, company, etc.)?  
      ☐ Yes. If yes, all questions must be answered congruently based on protocol    
         provisions. 
☒No. If no, the remainder of this section does not apply.  
References 
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Hu TW, Wagner TH, Bentkover JD, et al. Estimated economic costs of overactive bladder 
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Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and Treatment of Overactive 
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Gopal M, Haynes K, Bellamy SL, Arya LA. Discontinuation rates of anticholinergic 
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8.  
Kalder M, Pantazis K, Dinas K, Albert US, Heilmaier C, Kostev K. Discontinuation of 
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13.  Kuo HC. Bladder base/trigone injection is safe and as effective as bladder body injection of 
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16.  Peters KM, Carrico DJ, Perez-Marrero RA, et al. Randomized Trial of Percutaneous Tibial 
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18.  Staskin DR, Peters KM, MacDiarmid S, Shore N, de Groat WC. Percutaneous Tibial Nerve 
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19.  Peters KM, MacDiarmid SA, Wooldridge LS, et al. Randomized Trial of Percutaneous 
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39.  Bright E, Drake MJ, Abrams P. Urinary diaries: Evidence for the development and 
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satisfaction and perceptions of improvement with treatment for urinary incontinence: 
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doi:10.1002/nau.20243 
41.  Goode PS, Burgio KL, Kraus SR, et al. Correlates and predictors of patient satisfaction with 
drug therapy and combined drug therapy and behavioral training for urgency urinary 
incontinence in women. Int Urogynecology J. 2011;22(3):327-334. doi:10.1007/s00192-
010-1287-x 
42.  Ammi M, Chautard D, Brassart E, Culty T, Azzouzi AR, Bigot P. Transcutaneous posterior 
tibial nerve stimulation: evaluation of a therapeutic option in the management of 
anticholinergic refractory overactive bladder. Int Urogynecology J. 2014;25(8):1065-1069. 
doi:10.1007/s00192-014-2359-0 
43.  Lazarou G, Du C, Medamana J, Grigorescu B. Percutaneous tibial nerve stimulation 
associated with occipital headaches: a review of the adverse effects of percutaneous tibial 
nerve stimulation. Obstet Gynecol Int J. 2018;9(5). doi:10.15406/ogij.2018.09.00363