Clinical trial NCT05783219
Conditions: Overactive Bladder Urge Incontinence Fecal Incontinence
Keywords: lidocaine
Sponsor: University of Louisville
Start date: 2023-05-01; Completion date: 2024-04-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will be a double-blind randomized control trial comparing 4% lidocaine patch placed over the sacrum 3 minutes prior to a percutaneous nerve evaluation (PNE) procedure to a placebo patch in patients already scheduled to undergo a medically indicated percutaneous nerve evaluation (PNE). VAS pain score, The volume of injectable lidocaine used, Patient Satisfaction Score, rate of successful PNE (defined as successful placement of wire in the S3 spinal foramen), and the amplitude of perineal stimulation on a Likert scale will be collected immediately after the procedure. Patients will follow up in 1 week - as is standard of care with the PNE procedure. Adverse events such as pain or change in sensation will be recorded. Number of voids and incontinence episodes per day after the PNE procedure will be recorded. Overall satisfaction score will be recorded at that time. Rate of progression to Sacral nerve stimulator implantation will be collected.

The investigators hypothesize that patients in the lidocaine patch group will experience significantly less pain at the time of PNE as measured by a lower change in VAS pain score when compared with the control group.

Detailed description:
The study design will be a double-blind randomized control trial comparing 4% lidocaine patch placed over the sacrum 30 minutes prior to the procedure to placebo patch. Intervention and control patches will be in envelopes labeled with study number and located within the procedure area. A patch from the envelope corresponding to the patient will be placed by a medical assistant or co-investigator who is not associated with the PNE placement procedure 30 minutes prior to the procedure start. Number of voids and incontinence episodes per day prior to the PNE procedure will be recorded. A patch (intervention or control) will be removed by a medical assistant prior to provider entering the room in order to secure blinding. 1% lidocaine 10cc will be injected into the sacral procedure site for adequate pain relief. PNE procedure will then be performed. If inadequate analgesia is reported by the Patient during the procedure, additional injectable lidocaine will be administered in 5 cc increments, not to exceed 4.5 mg/kg of injectable lidocaine. The volume of injectable lidocaine used will be recorded. VAS pain scores prior to and immediately after procedure will be recorded. Patient Satisfaction Score, rate of successful PNE, rate of progression to SNS implantation, and amplitude of perineal stimulation of a Likert scale will be collected immediately after the procedure.

Patients will follow up in 1 week - as is standard of care with the PNE procedure. Adverse events such as pain or change in sensation will be recorded. Number of voids and incontinence episodes per day after the PNE procedure will be recorded. The overall satisfaction score will be recorded at that time.

Arms: arm 1: 4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure arm 2: Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure
Interventions: intervention 1: Lidocaine patch intervention 2: Placebo
Intervention descriptions: intervention 1: 4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure intervention 2: Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure

Protocol documents:
Prot_SAP_000.pdf: 
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RESEARCH PROTOCOL 
STUDY TITLE: Lidocaine patches prior to percutaneous nerve evaluation 
 
IRB Protocol Number: 22.0973 
Trial Registration: completed  
 
Protocol version: 2 
Protocol Date: 02-21-2023 
Funding: None  
 
Principal Investigator:  
Dr. Stacy Lenger, MD  
Department of Obstetrics, Gynecology & Women’s Health 
Division of Female Pelvic Medicine and Reconstructive Surgery 
550 South Jackson Street 
Louisville, KY  40202    
 
Study Sites:  
• University of Louisville Hospital  


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• UofL Physicians – Urogynecology; Springs Medical Center Office 
• UofL Physicians – Urogynecology Associates; 4431 Churchman Avenue, Louisville, KY 
 
 
 
 


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Background/Problem Statement 
 
Sacral neuromodulation (SNM) is an accepted therapy for refractory urinary urgency and frequency, 
urgency urinary incontinence, non-obstructive urinary retention, and fecal incontinence1. A common 
indication for SNM is overactive bladder (OAB). OAB is defined as a syndrome of urinary urgency, 
usually accompanied by urinary frequency and nocturia, with or without urgency urinary 
incontinence, in the absence of infection or other pathology.2 OAB affects approximately 34 
million adults in the United States, substantially affecting their quality of life.3 The initial 
treatment for OAB consists of diet and behavioral modifications, pelvic floor physical therapy, 
bladder training, and a trial of anticholinergic or beta-agonist medications. However, long-term 
adherence to these interventions is poor due to side effects and poor effectiveness.4  
Sacral neuromodulation (SNM) is a third-line treatment option for OAB that can have a 
particular impact on this population and success rates as high as 82% can be expected at 5 
years.56 SNM is typically administered with a test stimulation followed by permanent 
battery/pulse generator placement if successful. Successful test stimulation is defined as a 
reduction of one or more micturition symptoms of ≥50% compared to baseline.  Test 
stimulation can be performed as a staged procedure in the operating room or as a percutaneous 
sacral nerve evaluation (PNE) performed in the office. Though a patient is anesthetized in the 
operating room, discomfort with placement is a larger concern with office based PNE procedures 
– making increased comfort with this procedure essential.  


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Lidocaine is frequently used for analgesia with PNE placement. This is often performed with 
injectable lidocaine, however, other forms can be considered to improve patient comfort and 
clinical success – namely through topical lidocaine patches. Up to 5% (35 mg) of lidocaine 
patches are absorbed topically, producing analgesia within 30 minutes with a half-life of 6 to 8 
hours7. Transdermally absorbed lidocaine appears to have a very low rate of systemic 
absorption resulting in local analgesia and not anesthesia, a characteristic not shared with 
lidocaine infiltration. The exact mechanism of this differential effect is unknown, however, it is 
hypothesized that the lidocaine patch produces analgesia without blocking all the sensory and 
motor inputs in large, myelinated A-β sensory fibers 7.  The value of this relatively rapid onset 
medication with analgesic effects and without the associated discomfort of infiltration can be 
increased comfort for patients. The ability to potentially detect adverse sensation more 
sensitively in the office may also make this method of analgesia more effective.  
 
Objectives 
Primary outcome will be: 
• VAS pain scores measured on a 10 point scale before and after PNE procedure 
Secondary outcomes will be: 
• Patient Overall Satisfaction after PNE placement 
• Volume of injectable lidocaine used 
• Rate of successful PNE  
• Progression to permanent SNS implantation.  
• Amplitude of perineal stimulation 


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Our null hypothesis is that there will be no significant difference in change in VAS score 
between patients in the lidocaine patch group and the patients in the control group. 
 
We hypothesize that patients in the lidocaine patch group will experience significantly less 
pain at the time of PNE as measured by change in VAS pain score when compared with the 
control group.  
 
Study Design/Methodology 
Patients who have been scheduled for a PNE procedure will be will be consented for the study on 
the day of the procedure and screened for participation prior to the procedure by phone. 
Participants will be randomized with a stratified block randomization scheme (with a random 
block size of 4, 6, and 8 participants). Randomization sequence will be generated by statistician 
collaboratorr. All data will be recorded in the RedCap software and be maintained in that 
password-protected format until analysis. Data analysis will be performed by researchers 
associated with the IRB for this study. De-identified data will also be sent to statistician 
collaborator for analysis. The trial is powered to detect a change in VAS pain score of 1.5 points 
or more on a 10 point scale, a value that is taken to be the minimum clinically meaningful 
change for the VAS instrument.8,9  Data on identification key will be deleted at the conclusion of 
this study. Patient enrollment will conclude when 34 subjects, 17 of each group, have been 
enrolled in the study.  Sample size was determined using G*Power so that we have 80% power 
to detect a difference between groups of the minimum clinically meaningful effect size of 1.5 


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points or greater using the two-sample test at α=0.05 and an assumed standard deviation for VAS 
score of 1.5 points.    
 
Inclusion criteria:  
1. Female patients undergoing sacral neuromodulation for the management of their OAB 
with SMN trial with PNE without fluoroscopy. 
2. No contraindication to the use of lidocaine patch 
3. Age >18 years old 
 
Exclusion criteria  
1. Patients who are not candidates for SNM therapy 
2. Patients with contraindication to SNM including pregnancy 
3.  Allergy to lidocaine or adhesives  
4. Chronic pain as an indication for the PNE procedure 
 
Study design 
The study design will be a double-blind randomized control trial comparing 4% lidocaine patch 
placed over the sacrum 30 minutes prior to the procedure to placebo patch. Intervention and 
control patches will be in envelopes labeled with study number and located within the 
procedure area. A patch from the envelope corresponding to the patient will be placed by a 
medical assistant or co-investigator who is not associated with the PNE placement procedure 
30 minutes prior to the procedure start. Number of voids and incontinence episodes per day 


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prior to the PNE procedure will be recorded. A patch (intervention or control) will be removed 
by a medical assistant prior to provider entering the room in order to secure blinding. 1% 
lidocaine  will be injected into the sacral procedure site for adequate pain relief. PNE procedure 
will then be performed. If inadequate analgesia is reported by the Patient during the procedure, 
additional injectable lidocaine will be administered, not to exceed 4.5 mg/kg of injectable 
lidocaine. The volume of injectable lidocaine used will be recorded. VAS pain scores prior to and 
immediately after procedure will be recorded. Patient Satisfaction Score, rate of successful PNE, 
rate of progression to SNS implantation, and amplitude of perineal stimulation of a Likert scale 
will be collected immediately after the procedure. 
Patients will follow up in 1 week – as is standard of care with the PNE procedure. Adverse 
events such as pain or change in sensation will be recorded. Number of voids and incontinence 
episodes per day after the PNE procedure will be recorded. Overall satisfaction score will be 
recorded at that time.  
 
In summary, overall questionnaires and data being collected include: 
 
 
 
 
 
 
 


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Figure 1: Patient flow and outcomes:  
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed consent of patients scheduled to undergo 
PNE who meet inclusion/exclusion criteria 
EPIC review and subsequent Phone screen for 
participation followed by in clinic consent for 
Drug dispensation  
Lidocaine patch for 30 minutes 
prior to procedure  
Adhesive patch for 30 minutes 
prior to procedure 
PNE procedure performance. Measurement of VAS 
pain scale, Amplitude of perineal sensation, Volume 
of injectable lidocaine used, and Patient satisfaction 
scores are collected 
Rate of successful progression to stage II  


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Study has been registered on Clinicaltrials.gov 
 
 
Participant Recruitment Methods 
Subjects will be recruited from the ULP Female Pelvic Medicine and Reconstructive Surgery 
(FPMRS) practice at the University of Louisville Health Care Outpatient Center (HCOC), 
Urogynecology Associates office at 4431 Churchman Avenue and the Springs Medical Center. 
All Patients receiving care at University of Louisville Urogynecology who meet screening criteria 
will be called prior to their PNE procedure to assess for willingness to participate in this study. 
Women meeting study criteria will be approached by a member of the research team for 
consent prior to their PNE procedure. Women interested in the study will have the study 
explained to them, the consent reviewed, and questions addressed in a confidential manner in 
a private room. At the time of consent, participants will be informed that their participation in 
this research is voluntary and that they may discontinue participation without penalty at any 
time. Participants will not be reimbursed for their participation in this research study.  
 
 
Informed Consent Process 
Patients will be called prior to their procedure to assess if they are interested in participation in 
this study. If they are interested, they will present with sufficient time prior to their procedure 


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to review and sign their consent form and have their patch (lidocaine vs placebo) placed (in 
place for 30 minutes). Consent form is otherwise attached. 
 
Research Procedures 
Please see study design/methodology section for further details. In addition all members of the 
research team will be educated on the study protocol at a division meeting or meeting set up 
for training purposes.  All members of the research team will be able to ask questions at this 
education session and after the education session to ensure they are comfortable with all 
aspects of the study protocol. Members of the research staff that will be using REDCap 
(Research Electronic Data Capture) will be trained on how to use this database.  
 
 
Minimizing Risks 
Potential risk of breach of confidentiality will be mitigated by the redcap software and use of 
password protected University of Louisville computers for data entry and analysis. No one other 
than study investigators will be able to access data and it will be deleted at the conclusion of 
the study. Patient will be assigned a study number during the consent process and it will be 
associated with a patient identifier in REDCAP. No other location will have this information.  
 
As this study is minimal risk there will not be oversight of the data. As this drug is available over 
the counter and is not investigational, it will be placed in envelopes at the start of the study and 
dispensed by investigators and clinic staff.  


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All expected adverse events are of mild severity. 
For this study, the following standard adverse event (AE) definitions are used: 
• Adverse event: Any unfavorable and unintended sign, symptom, or disease temporally 
associated with the use of a medical treatment or procedure, regardless of whether it is 
considered related to the medical treatment or procedure. 
• Serious Adverse Event (SAE):  Any AE related to the study drug that results in any of the 
following circumstances:  death, life-threatening, event requiring inpatient hospitalization 
or prolongation of existing hospitalization, persistent or significant disability/incapacity 
 
AEs are graded according to the following scale: 
• Mild: An experience that is transient and requires no special treatment or intervention.  The 
experience does not generally interfere with usual daily activities.   
• Moderate: An experience that is alleviated with simple therapeutic treatments. The 
experience impacts usual daily activities.   
• Severe: An experience that require therapeutic intervention. The experience interrupts 
usual daily activities. If hospitalization (or prolongation of hospitalization) is required for 
treatment of something related to the study drug, it becomes a SAE.  
 
The study uses the follow AE attribution scale: 


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• Not related: The AE is clearly not related to the study procedure (i.e., another cause of the 
event is most plausible and/or a clinically plausible temporal sequence is inconsistent with 
the onset of the event). 
• Possibly related: An event that follows a reasonable temporal sequence from the initiation 
of study procedures, but that could readily have been produced by a number of other 
factors. 
• Related: The AE is clearly related to the study procedures.  
 
Expectedness of Adverse Events:  
• Uncommon: discomfort over the area the lidocaine patch was placed and discomfort with 
the PNE procedure itself  
• Rare: Allergy to adhesive bandage or lidocaine, lidocaine toxicity 
 
Plan for Analysis of Results 
Summary statistics for demographics, procedures variables, and outcome measures will be 
summarized for each treatment group (lidocaine patch and control patch) using means, 
standard deviations, counts and proportions, as appropriate.  Differences in these variables will 
be assessed using the two-sample t-test for continuous variables and the Fisher exact test for 
categorical variables.  A two-sample t-test will be used to assess differences in the primary 
outcome of change in VAS score after procedure between groups.  Differences in secondary 
outcomes will be considered using the two-sample t-test for continuous variables and the 


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Fisher exact test for categorical variables.  Transformations and/or non-parametric methods 
will be used if continuous data are found to substantially violate the assumption of approximate 
normality.  Multivariate linear/logistic regression models may be used to assess the impact of 
other variables onto primary or secondary outcomes.  Throughout, a significance level of 
α=0.05 will be used, and all tests will be two-sided.  Data analysis will be performed by a 
biostatistician collaborator using the R statistical software. 
 
Research Materials, Records, and Privacy 
 
Data that is to be collected with this study and entered into an encrypted database: 
 
Demographic data 
• Name 
• Date of birth 
• Age  
• Weight 
• BMI 
• Race/ethnicity 
• Smoking status  
• Indication for PNE 
• Contact information  
• Randomization assignment 


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• Study ID number 
• Number of voids and incontinence episodes per day prior to the PNE procedure and 1 
week after the PNE procedure  
Procedural variables:  
• Total amount of lidocaine used 
• Side of PNE lead stimulated 
• Amplitude of stimulation at completion of procedure 
 
• VAS pain score prior to and after the PNE procedure. 
• Satisfaction scale immediately post procedure and 1 week after the procedure. 
1-week follow up variables:  
• Adverse events of PNEs such as uncomfortable change in perineal sensation present at 
the 1 week post-procedure visit  
• Patient satisfaction score immediately after the PNE procedure and at the 1 week post-
procedure visit 
• Number of days with successful stimulation 
• Amplitude of stimulation at time of removal 
• Bladder/ fecal diary with symptoms during the PNE trial period 
 
3-month follow up 
• Number of patients with a “successful” PNE who underwent an implantation  
• Number of patients with a “successful” PNE who planned implantation but had not yet 
scheduled 


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• Number of patients with a “unsuccessful” PNE who underwent staged procedure 
• Number of patients with a “unsuccessful” PNE and what other treatment options they 
pursued in the next 3 months 
Successful PNE is defined as PNE procedure which resulted in successful wire placement. 
Unsuccessful PNE is defined as PNE procedure which did not result in successful wire 
placement. 
Implantation defined as stage 2 procedure after interval PNE results showed >/=50% symptom 
reduction. 
Staged procedure is a stage 1 procedure in the operating room as opposed to being performed 
as an outpatient PNE 
 
This information will be sourced from the subjects themselves and questionnaire templates for 
satisfaction score and VAS pain score will be attached to this document as appendices. This 
information is necessary to display if the intervention results in an increased comfort with the 
PNE procedure or increased satisfaction with the procedure. Number of voids and incontinence 
episodes before and after the PNE procedure is recorded to examine if a change in procedural 
effectiveness occurs with this intervention.  
 
All identifying information and data collected during the course of this study will be kept secure 
and strictly confidential. For confidentiality, only research team members will have access to 
the study information and the information entered into the database. Subjects will be assigned 


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a unique study ID that will be used on all case report forms and database reporting. The 
database that will be used is REDCap which is HIPPA (Health Insurance Portability and 
Accountability Act of 1996) compliant, encrypted, and password protected. Any hard copies will 
be maintained in a locked cabinet in a locked office by a member of the research team.  
The research personnel involved in this study are CITI and HIPAA trained. If new research 
personnel are added to the study, an amendment will be submitted to and approved by the IRB 
before being allowed to participate in the study 
 
 
 
References 
 
1.  
Goldman HB, Hassouna MM, Lloyd JC, et al. International Continence Society best 
practice statement for use of sacral neuromodulation. 2018;(January):1-26. 
doi:10.1002/nau.23515 
2.  
Haylen BT, Ridder D de, Freeman RM, et al. An International Urogynecological 
Association (IUGA)/International Continence Society (ICS) joint report on the terminology 
for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29:4-20. doi:10.1002/nau 
3.  
Schlenk EA, Erlen JA, Dunbar-Jacob J, et al. Health-related quality of life in chronic 
disorders: A comparison across studies using the MOS SF-36. Qual Life Res. 1997;7(1):57-
65. doi:10.1023/A:1008836922089 
4.  
Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder 
(non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2012;188(6 SUPPL.):2455-2463. 
doi:10.1016/j.juro.2012.09.079 
5.  
Gupta P, Ehlert MJ, Sirls LT, Peters KM. Percutaneous Tibial Nerve Stimulation and Sacral 
Neuromodulation: an Update. Curr Urol Rep. 2015;16(2):4-9. doi:10.1007/s11934-014-
0479-1 
6.  
Siegel S, Noblett K, Mangel J, et al. Five-Year Followup Results of a Prospective, 
Multicenter Study of Patients with Overactive Bladder Treated with Sacral 
Neuromodulation. J Urol. 2018;199(1):229-236. doi:10.1016/j.juro.2017.07.010 
7.  
Gammaitoni A, Alvarez N, Galer B. Safety and tolerability of the lidocaine patch 5%, a 
targeted peripheral analgesic: A review of the literature. J Clin Pharmacol. 
2003;43(2):111-117. 
8.  
Delgado DA, Lambert BS, Boutris N, et al. Validation of Digital Visual Analog Scale Pain 
Scoring With a Traditional Paper-based Visual Analog Scale in Adults. JAAOS Glob Res 


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Rev. 2018;2(3):e088. doi:10.5435/jaaosglobal-d-17-00088 
9.  
Kelly AM. The minimum clinically significant difference in visual analogue scale pain score 
does not differ with severity of pain. Emerg Med J. 2001;18(3):205-207. 
doi:10.1136/emj.18.3.205 
 

ICF_001.pdf: 
 
 
 
 
Version Date: 4/4/23 
Version Number: 3 
Page 1 of 5 
 
 
TITLE OF RESEARCH STUDY: Lidocaine patches prior to percutaneous nerve evaluation 
 
 
Introduction and Background Information 
You are invited to take part in a research study about lidocaine patches prior to Percutaneous Sacral Nerve 
Evaluation (PNE). The study is being conducted under the direction of Dr. Stacy Lenger, MD at the University of 
Louisville.  About 34 local participants will be invited to take part in this research 
 
Why is this study being done? 
The purpose of this study is to determine if a lidocaine patch applied to the skin decreases pain from the PNE 
procedure. Lidocaine is the numbing agent commonly used during this procedure, and in other similar 
procedures, to reduce discomfort. Typically this numbing agent is injected beneath the skin and into the tissue 
at the site of this procedure. The lidocaine patch is another route of delivery of lidocaine – which can also be 
used to decrease skin discomfort. 
 
What will happen if I take part in the study? 
Your participation in the study will involve undergoing your planned PNE procedure, however, you will present 
30 minutes prior to your planned procedure time and have a patch placed on your lower back. You will be 
randomized to either receive a patch containing lidocaine or a “placebo” patch which will not contain 
lidocaine. Your patch will be randomized between these two interventions. Randomization will occur by a 
procedure similar to flipping a coin – with you having an equal chance of being in either group. All participants 
will receive injectable lidocaine per standard of care as well. Your participation in this study will last for up to 3 
months after a possible stage II sacral neuromodulation procedure.  
 
Your urinary frequency prior to the procedure will be recorded. Before and after the procedure visual analog 
scale (VAS) pain score will be collected. At the completion of the PNE procedure the total amount of injectable 
lidocaine used, the site of stimulation for the PNE procedure, the amplitude of stimulation felt with the 
procedure, and a satisfaction scale with the procedure will be collected. 1 week after the procedure you will 
be seen for evaluation related to your PNE procedure per standard of care. At that 1 week office visit any 
adverse events, a satisfaction score, the number of days with successful stimulation, the amplitude of the 
stimulation felt, and your bladder/fecal diary will be collected. At that 1 week visit and thereafter you will 
undergo standard of care management of your urinary or fecal incontinence. Your data will again be accessed 
at 3 months post-PNE procedure via the electronic medical record to determine what interventions you have 
since undergone for this condition since the completion of the PNE procedure. You will not be contacted for 
the collection of this 3 month information.  
 
What are the possible risks or discomforts from being in this research study? 
The following details the known risks related to this research and how often they may occur.  
• Uncommon: discomfort over the area the lidocaine patch was placed  
• Rare: Allergy to adhesive bandage or lidocaine 
 
 
.  
In addition, you may suffer harms that we do not anticipate  
 


 
 
 
 
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What are the benefits of taking part in the study? 
You may or may not benefit personally by participating in this study. The information collected may not 
benefit you directly; however, the information may be helpful to others.   
 
The possible benefits of this study include reduced pain with the procedure 
 
Will I be paid? 
You will not be paid for your time, inconvenience, or expenses while you are in this study.     
 
What are the Costs? 
You will not be billed for the study drug (lidocaine patches) or placebo (athletic tape) in this study.  
 
You or your insurance company will be billed for all office visits, tests, additional medications and procedures 
that are part of your routine medical care and this research study.  You will be responsible for paying your co-
pay that is associated with any office visit, test, medication or procedure.  Some insurance companies will not 
pay for medical bills for people who participate in a research study.   It is your responsibility to find out what 
costs, if any, your insurance company will cover before taking part in the study. If you need help finding out 
what your insurance company will cover, please ask your study doctor for assistance. If your insurance 
company does not pay for your bills associated with this study, you will be responsible for paying them. 
 
If you are injured, there may be additional costs to you for participating in this research study. 
 
What other choices do I have if I do not take part in the study? 
Instead of taking part in this study, you could choose to: 
• Undergo PNE procedure with the standard of care use of injectable lidocaine for discomfort 
• Undergo PNE procedure with use of lidocaine patch and injectable lidocaine for discomfort 
 
What if I get injured on the study? 
• If you are injured by being in this research study, the study doctor will arrange for you to get 
medical treatment. The sponsor, the study site, or your study doctor has not set aside money 
to pay for treatment of any injury. You and your insurance will be billed for the treatment of 
these injuries. Before you agree to take part in this research study you should find out whether 
your insurance will cover an injury in this kind of research. You should talk to the study doctor 
or staff about this. If you are injured, there is no money set aside for lost wages, discomfort, 
disability, etc. You do not give up your legal rights by signing this form. If you think you have a 
research related injury, please call your study doctor (Stacy Lenger: (502)5887663)  
 
Information Available on ClinicalTrials.gov  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov. This website will not 
include information that can identify you. The website will include a summary of the results of the clinical trial 
 
How will my information be protected? 
The data collected about you will be kept private and secure by the password protected and secure RedCap 
program.  
 
HIPAA RESEARCH AUTHORIZATION 


 
 
 
 
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What information will be collected, used, or shared? 
If you sign this form, the research team working on this study will use and/or share your health information to 
answer the research questions for this study, and to make sure that the research was done correctly.  They 
may also collect other information including your name, address, date of birth, medical history, and other 
information from your medical records from this institution and other institutions involved with this research, 
as well as from your other healthcare providers (which may include information about HIV status, drug, 
alcohol or sexually transmitted disease treatment, genetic test results, or mental health treatment).  Once 
your information leaves your medical record, it may no longer be protected by HIPAA. 
 
Who will see, use or share the information? 
The people who may request, receive, or use your private information include the researchers and the study 
team.  We may also share your information with other people, for example, if needed for your clinical care, for 
the research study activities, or for regulatory/compliance functions.   
 
Additionally, by signing this form, you give permission to the research team to share your information with 
others outside of the University of Louisville.  This may include the sponsor of the study and its agents or 
contractors, those who provide funding to the study, outside providers, study safety monitors, government 
agencies, other sites in the study, data managers, and other agents and contractors used by the study team.  If 
applicable, your information may also be shared as required by law (for example, to collect or receive 
information for reporting child abuse or neglect, preventing or controlling disease, injury, or disability, and 
conducting public health surveillance, investigations or interventions.)  
 
We try to make sure that everyone who sees your information keeps it confidential, but we cannot guarantee 
this.  Those who receive your information may not be required by federal or state privacy laws to protect it 
and may share your information with others without your permission.  
 
How long will information be used or shared? 
The time period when information can be used or shared ends when all activities related to this study are 
completed.   
 
May I review or copy the information obtained from me or created about me? 
Some information collected about you only for this research study may be kept in a research study record 
separate from your medical record, and some research information may also be part of your medical 
record.  You will not have access to this research information until the end of the study.  However, it will be 
available to your physicians if needed for your care. 
 
 
Will my information be used for future research? 
Your data will not be stored or shared for future research. 
 
Can I stop participating in the study at any time? 
Taking part in this study is completely voluntary. You may choose not to take part at all. If you decide to be in 
this study, you may change your mind and stop taking part at any time. You will not be penalized or lose any 
benefits for which you qualify.  
 


 
 
 
 
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Who can I contact for questions, concerns and complaints? 
If you have any questions about your rights as a research participant, you may call the Human Subjects 
Protection Program Office at (502) 852-5188.  You may discuss any questions about your rights as a research 
participant, in private, with a member of the Institutional Review Board (IRB).  The IRB is an independent 
committee made up of people from the University community, staff of the institutions, as well as people from 
the community not connected with these institutions.  The IRB has approved the participation of human 
participants in this research study.  
 
If you have any questions about the research study, please contact Rodger Rothenberger, MD: (502)5887663 
 
If you have concerns or complaints about the research or research staff and you do not wish to give your 
name, you may call this toll free number: 1-877-852-1167.  This is a 24 hour hot line answered by people who 
do not work at the University of Louisville.   
 
 
 
 
 
Acknowledgment and Signatures  
This document tells you what will happen during the study if you choose to take part. Your signature and date 
indicate that this study has been explained to you, that your questions have been answered, and that you 
agree to take part in the study.  You are not giving up any legal rights to which you are entitled by signing this 
informed consent document though you are providing your HIPAA authorization as outlined in this informed 
consent document.  You will be given a copy of this consent form to keep for your records.  
 
____________________________________ 
______________________________ 
____________ 
Printed Name of Participant 
 
 
 
Signature of Participant  
 
 
Date Signed 
 
____________________________________ 
______________________________ 
____________ 
Printed Name of Person Explaining Consent (PEC) 
Signature of PEC (if not an investigator)  
Date Signed 
 
 
 
 
 
 
 
_________________________________ 
 
______________________________ 
____________ 
Printed Name of Investigator (PI, Sub-I, or Co-I)  
Signature of Investigator (PI, Sub-I, or Co-I)  
Date Signed 
 
 
__________________________________________________________________________________________
____ 
 
24 hour phone number for participants to call for questions: (502) 588-7660 
Investigator(s) name, degree, phone number, University Department, & address: 
Dr. Stacy Lenger, MD  
Department of Obstetrics, Gynecology & Women’s Health 
Division of Female Pelvic Medicine and Reconstructive Surgery 
550 South Jackson Street 
Louisville, KY  40202              


 
 
 
 
Version Date: 4/4/23 
Version Number: 3 
Page 5 of 5 
 
 
Site(s) where study is to be conducted:  
• University of Louisville Hospital  
• UofL Physicians – Urogynecology; Springs Medical Center Office 
• UofL Physicians – Urogynecology Associates; 1900 Bluegrass Ave. Louisville, KY 40215