Conditions: Urethra Issue Pelvic Organ Prolapse Urinary Incontinence Vaginal Vault Prolapse Cystocele Uterine Prolapse Vaginal Prolapse Pelvic Floor Disorders
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 63
Healthy volunteers: no

Brief summary:
This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void, strong desire to void, or maximum cystometric capacity) and determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts pain/discomfort, filling metrics, and voiding metrics.

Detailed description:
This trial is a randomized, double blind, controlled trial for patients undergoing complex cystometric evaluation. Patients will undergo routine complex cystometric evaluation for acquisition of baseline data using a small amount of intraurethral aqueous jelly for catheter lubrication. Then, they will be randomized to instillation of either placebo (additional intraurethral aqueous jelly, 5ml) or intraurethral 2% lidocaine jelly. Participants then undergo complex cystometry a second time. Normal variations in studies with placebo will be compared to variations within the 2% lidocaine jelly group to determine if cystometric parameters are altered in any clinically important ways. Patient discomfort will also be evaluated by both the patient and the urodynamics advanced practice nurse.

Arms:
arm 1: 5ml of Water Based Lubricating Jelly arm 2: 5ml of Lidocaine 2% Jelly

Interventions: intervention 1: Water-Based Vaginal Lubricant intervention 2: lidocaine topical
Intervention descriptions: intervention 1: 5cc water based jelly applied intraurethral intervention 2: 5cc 2% lidocaine jelly applied intraurethral

Protocol document:
Prot_SAP_000.pdf: 
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Lessons on Urethral Lidocaine in Urodynamics (“LULU”): Impact of intraurethral
lidocaine on cystometric parameters and discomfort, a RCT
NCT04038099
11/22/2019


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Lessons on Urethral Lidocaine in Urodynamics (“LULU”): Impact of intraurethral
lidocaine on cystometric parameters and discomfort, a RCT
Abstract
Complex cystometric studies are often conducted to assess for and clarify incontinence.
In current practice, intraurethral aqueous jelly is used to lubricate and insert urethral catheters
for these studies.  Patients commonly complain of urethral discomfort and/or pain with catheter
insertion.  Two percent lidocaine jelly has not been routinely used in practice for cystometric
catheter insertion due to the unknown impact it may or may not have on complex cystometric
parameters.  Previous studies evaluating the use of 2% lidocaine jelly for office cystoscopy have
not proven to consistently provide substantial relief of discomfort.  However, a recent study
using 2% lidocaine jelly for catheter insertion during complex cystometric evaluation did
demonstrate significant relief of discomfort.  Some studies have evaluated 2% lidocaine jelly use
during complex cystometric evaluation in neurogenic populations, indicating a surprising
increase in detrusor overactivity with 2% lidocaine jelly use.  However, few studies have
evaluated the impact of 2% lidocaine jelly in a non-neurogenic population. If use of 2%
lidocaine jelly was found to improve discomfort during complex cystometric studies in this
patient population without substantially altering the study’s findings, this could impact clinical
practice in an important way.  Herein, we propose a randomized, double blind, controlled trial for
patients undergoing complex cystometric evaluation.  Patients will undergo routine complex
cystometric evaluation for acquisition of baseline data using a small amount of intraurethral
aqueous jelly for catheter lubrication.  Then, they will be randomized to instillation of either
placebo (additional intraurethral aqueous jelly, 5ml) or intraurethral 2% lidocaine jelly.
Participants then undergo complex cystometry a second time.  Normal variations in studies with
placebo will be compared to variations within the 2% lidocaine jelly group to determine if


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cystometric parameters are altered in any clinically important ways.  Patient discomfort will also
be evaluated by both the patient and the urodynamics advanced practice nurse.
Purpose of Study
This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts
sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void,
strong desire to void, or maximum cystometric capacity) and determine whether the use of
intraurethral 2% lidocaine jelly meaningfully impacts pain/discomfort, filling metrics, and voiding
metrics.
Hypothesis: In women without known voiding dysfunction being assessed for urinary
incontinence by urodynamic studies (UDS), the use of intraurethral 2% lidocaine jelly during
cystometry and pressure flow study (PFS) will not meaningfully impact sensation during filling
and will decrease discomfort for patients.
Significance of the Study
Patients often complain that urodynamic bladder testing is uncomfortable and even
painful, for some.  Intraurethral lidocaine 2% jelly has been used to demonstrate increased
patient satisfaction with comfort during this procedure.  However, the effect of intraurethral
lidocaine jelly on urodynamic test results has not been fully studied.  Considering that lidocaine
jelly is a local anesthetic, it may have a numbing effect, potentially increasing time to first
sensation and bladder capacity, decreasing ability to empty the bladder, and may potentially
mask detrusor overactivity (DO).  However, if the local anesthetic has no effect on urodynamic


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test results, one may consider changing practice to include intraurethral 2% lidocaine jelly with
urodynamic testing to improve patient satisfaction and comfort.
Background of the Problem
Standard teaching for the performance of UDS is that after completion of the un-
instrumented uroflowmetry, cystometry is completed using plain intraurethral aqueous jelly for
insertion of the transurethral pressure catheter. Clearly, this can be a source of discomfort and
pain for the patient. An alternative to plain lubricant, such as 2% lidocaine jelly, may relieve
discomfort for patients but could theoretically impact or distort important cystometry findings,
e.g., first or strong sensation and presence/absence of DO. Further, voiding could be affected if
numbing the urethra blunts sensory nerves that serve to amplify bladder contractions and
maintain efficient bladder emptying.(1, 2) A recent study of healthy volunteers randomized to
intraurethral aqueous jelly versus 2% lidocaine jelly did not identify any detriment to voiding
efficiency using lidocaine but did find greater interrupted flow patterns and more
electromyography (EMG) activity during micturition when using lidocaine.(3) This study found no
difference in pain perception between groups. Similarly, a meta-analysis of 9 randomized trials
assessing lidocaine jelly versus plain jelly lubrication for office flexible cystoscopy did not
suggest a significant difference in the efficacy of pain control using lidocaine.(4) Conversely, a
different trial that compared water-based lubricant and 2% lidocaine jelly for UDS in women did
find substantially less pain for patients using the lidocaine jelly.(5)
Neither of the above two trials of UDS in women compared participants to themselves to
determine how filling and voiding metrics may change before/after lidocaine jelly was applied. It
remains uncertain whether these parameters would change in clinically meaningful ways with
the addition of lidocaine, and the possible benefit of lidocaine—i.e., decreased discomfort for the


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patient—has not been definitively proven or disproven. Using patients as their own controls, this
proposal aims to determine if the use of intraurethral 2% lidocaine jelly during cystometry and
pressure flow study impacts filling and emptying measures while assessing patient discomfort at
various time points during their procedures.
One prior study utilizing patients as their own control evaluated patients with urgency but
no urge incontinence and reported DO on a repeat cystometry after no DO was observed on
initial cystometry, indicating that lidocaine jelly may increase DO. (6) Additional studies have
explored the effect of intravesical lidocaine on cystometric results within neurogenic populations,
but few studies to date have looked at the effect of lidocaine jelly on cystometric parameters and
DO in the normal population of patients with incontinence in the absence of neurogenic disease.
Methods & Analyses:
Urodynamic testing will be performed in procedure rooms by qualified advanced practice
nurses in the field of female pelvic medicine and reconstructive surgery (FPMRS). Eligible
patients meeting inclusion criteria will be consented for study participation prior to urodynamic
testing.  Standard urodynamic testing will be conducted, i.e., first un-instrumented uroflowmetry,
then cystometry (including leak point pressure assessments, LPP) and a pressure flow study
(PFS) with 1-2ml of aqueous jelly in the urethra. UDS will be completed with a dual-sensor 7-Fr
catheter inserted through the urethra into the bladder and a second 7-Fr catheter in the vagina.
Patch electrodes will be adhered peri-anally in the standard fashion for EMG. Patients will be
filled with room-temperature sterile water at 60mL/min. Volumes at first sensation, first desire to
void, strong desire to void, and maximum cystometric capacity will be recorded. Presence or
absence of DO during cystometry will be documented. Other measures (detailed below) will be
recorded during cystometry and PFS. After the patient voids for her first PFS, she will be


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randomized (1:1) to either additional water-based lubricant (placebo) or lidocaine 2% jelly
(5mL).
Randomization will be stratified by presence/absence of DO on the initial cystometry. A
balanced randomization scheme will be generated with equal numbers of placebo and lidocaine.
Identically appearing study drug syringes will be placed in consecutively numbered opaque
envelopes by an unmasked study coordinator not participating in the procedure visit or study
analyses. Both the urodynamic nurse and patient will be blinded to the type of lubricant.
After randomization, the urethral catheter will be removed and 5mL of either placebo or 2%
lidocaine will be injected into the urethra. The patient will sit for 5 minutes to allow lidocaine to
take anesthetic effect.  The catheter is then replaced, and cyostometry and PFS will be
repeated. A continuous pain scale from 0 to 100 (visual analog scale) will be used by the patient
to report her pain level during cystometry #1 (during catheter insertion and at maximum
cystometric capacity), PFS #1, overall UDS #1, cystometry #2 (during catheter insertion and at
maximum capacity), PFS #2, and overall UDS #2 discomfort.  At the end of the procedure, the
urodynamic nurse will also provide a subjective assessment of patient discomfort.
Planned Analyses & Power Calculation:
The primary outcome is the volume at which a participant perceives a strong desire to
void.  Statistical analyses will estimate the confidence interval for this outcome measure
between the two arms of the study (i.e., using 2% lidocaine vs. aqueous jelly) through the
standard calculation for the difference in means when standard deviations of the two arms are
unknown, i.e., through the Student’s t distribution.  As it is thought that there will be no
difference in the mean value of the two arms, the study will be designed as an equivalence trial.
Since DO may alter findings, it is planned to stratify the randomization for DO in order to insure
a balance between the arms for this variable. Prior to randomization, each patient will undergo a


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baseline standard cystometry without lidocaine, and DO (present or absent) will be obtained
from this evaluation.  The observations from this baseline cystometry provide for an interesting
and novel analysis: the baseline measure of volume at strong desire to void may serve as a
covariate to adjust for individual patient variability.  That is, comparisons of the difference in the
baseline measure and the experimental measure will provide a patient “standardized” evaluation
of her additional volume following the baseline.  Analysis of the primary outcome will account for
patient variability with standardization by the value of the baseline measure.
Beyond the primary outcome cystometric evaluations are numerous secondary
outcomes such as pain/discomfort with filling and emptying, presence/absence of DO, and
emptying metrics including flow rates, post-void residual, EMG activity, and detrusor pressures
(max and at peak flow). Continuous measures will use the Student’s t distribution as with the
primary outcome.  Binary and ordinal outcomes will be evaluated using logistic regression. The
use of logistic regression for the ordinal outcomes is through the proportional odds model and
combines with the cumulative logit link.  All of these evaluations may incorporate the baseline
urodynamic study metrics as a covariate (as described above for the primary outcome).
Assuming an average strong desire to void during cystometry (with plain lubricant gel) of
300mL, standard deviation of 100mL (3, 5), a non-inferiority margin of 75mL (i.e., 25% of
300mL), Power (1-β) of 0.80 and α of 5%, 31 participants per study arm (i.e., 62 total) are
needed to demonstrate “equivalence” in sensation during cystometry using plain lubricant gel
versus lidocaine gel. Allowing for 12% participants being unable to complete the second half of
the UDS, a total of 35 participants per study arm (i.e., 70 total participants) will be enrolled.
In the placebo group, the data from the two filling cystometry tests can be compared
(sensation metrics, DO presence/absence, and compliance) to establish “normal variability”.
Anecdotally, patients commonly tolerate a second fill better. With this normal variability better


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defined, we will be able to assess for changes attributable to the lidocaine in the group receiving
the anesthetic jelly—specifically, whether volume of first sensation or bladder capacity is
altered.  We can also assess lidocaine’s impact on bladder emptying by comparing voiding
metrics.  In patients with repetitive DO on their first cystometry, we will be able to assess
whether they continue to demonstrate DO on their second cystometry with lidocaine.
Primary Outcome: Assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts
sensation during filling (specifically, strong desire to void).
Secondary Outcomes: Determine whether the use of intraurethral 2% lidocaine jelly
meaningfully impacts the following:
Pain/ Discomfort
1. Measured by a visual analog scale during cystometry (catheter insertion and at
maximum cystometric capacity), during PFS, and post-procedure
2. Provider perception of patient discomfort
Filling Metrics (besides sensation)
3. Presence/ absence of detrusor overactivity (DO)
4. Compliance (ΔVolume/ΔPdet)
Voiding Metrics
5. Maximum flow rate (mL/sec)
6. Voiding pattern: normal, intermittent, interrupted
7. Detrusor void (yes/no) vs. Valsalva vs. mixed void
8. Voided volume and post-void residual (mL)
9. Voiding efficiency, i.e., voided volume/ (voided volume + PVR) (3)


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10. Pdetmax (cm H2O)
11. Pdetpeak flow (cm H2O)
12. EMG activtity
Participant Eligibility
Inclusion Criteria
Exclusion Criteria
Female patients
 Diagnosis of pelvic pain, interstitial cystitis, or
bladder pain syndrome
>18 years of age
 Known neurogenic disease impacting voiding/
continence (e.g., Parkinson disease, multiple
sclerosis, myasthenia gravis, recent stroke)
Already scheduled (or being scheduled) for UDS
to assess urinary incontinence
 Active UTI
Able to speak and read in English
Pelvic organ prolapse that is unable to be easily
reduced
Pregnancy or breastfeeding
Allergy or hypersensitivity to lidocaine or local
anesthetics
Ethical Conduction
The study site will have a principal investigator and study coordinator, both skilled in
conduct of IRB-approved clinical research, responsible for obtaining and appropriately
documenting informed consent of each patient before beginning any study related procedure.
Once patients have completed informed consent and have enrolled, each participant will be
assigned a Participant ID that is an anonymous patient study number.  Only the research
coordinators and the site PI will have access to the list linking medical record number to
participant ID.  A research coordinator not involved in the care of the patient will have
knowledge of whether a patient received lidocaine jelly or placebo (water based lubricant).  The
research coordinator and site PI will have the responsibility for securing original source
documents containing any identifiable patient data.  Each patient’s study documents will be kept


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under an individual tab in a binder, and the binder(s) will be stored in a locked cabinet and
office.  All information collected about the subject during the course of this study will be kept
confidential to the extent permitted by law.  Besides the specified study team, other access to
study records or data would only be by the IRB or the study sponsor (SUNA) at their request.
All information the subject has provided will be kept in a research record and stored in a locked
office and on a secure, password protected computer.  Research information will not be made a
part of the participant’s regular medical record.  There is no personal information (name, social
security number, etc.) about the subject that is associated with subject’s research data; a
Participant ID number will indicate a subject’s identity on the research records.  Patients
routinely are escorted to exam rooms alone, but they may choose to have a family member or
spouse present if that is her preference.  The informed consent and the history and exam
findings will be collected in a private room.  The informed consent will be written and provided in
English.  Either the research coordinator or another member of the research team (PI or co-
investigator) will be obtaining the consent, and the patient will sign and date/time her name to
indicate understanding, which will be observed and countersigned by the person obtaining the
consent.  No matter what position of authority a research member has, the subject will be
assured of the right to refuse to participate and/or the right to withdraw at any point in the study.
The urodynamics nurse will be trained to minimize discomforts during the procedure.
A patient’s Participant ID number will be provided to the central data collecting center
(UTSW) with no personal information.  Further, data will be entered using REDCap, a Web-
based, HIPAA-complaint tool used by many major medical institutions.  REDCap facilitates
electronic form building and data collection.  It has an automatic audit trail, report builder
capability and data quality module.  REDCap can export data to SAS, SPSS, R, STATA, or
Microsoft Excel.   The REDCap database will reside on a secure UTSW server with continuous
backup.  Only authorized personnel with designated rights can access this study, and that at


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various levels.  For example, a coordinator will be able to enter and check data, but cannot
design screens.  REDCap provides a protocol event schedule where specific forms are linked to
events (visits) in the protocol.  Authentication used in the REDCap application is compliant with
the UT Southwestern Medical Center’s Health System password and security standards.
Project Timeline
Research Task
Projected Time
Course
Completion of IRB application, site review, project start-up processes,
registration with clinicaltrials.gov
3 months
Participant recruitment, data collection (anticipating 5-6 procedures/ month)
12 months
Data analyses
1 month
Manuscript preparation/ submission/ edits, SUNA presentation preparation,
final data entry in clinicaltrials.gov
2 months
TOTAL
18 months
Study Budget
Please see appendix A.  Given that we will be conducting a 2nd CMG and PFS on
patients already having urodynamic studies performed, we will not need any additional supplies
other than the randomized jelly syringes.  A registered nurse will prepare blinded jelly syringes
of lidocaine vs. aqueous jelly solution.  Research coordinator/urodynamicist time is included in
the study budget.  Salary support includes time for the nurse practitioner and/or physician(s) to
submit to the IRB, VELOS, clinicaltrials.gov, and data entry within REDCap system, as well as
time for consenting patients and performing additional complex cystometrogram with pressure
flow study.  It is estimated that the consent process and additional procedure time will be
roughly 150 hours for 70 patients over the course of 12 months.  Additional data entry support
may be required, and this is calculated in the budget, as well.
Research Environment


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UT Southwestern Medical Center (UTSW) is a large, research-oriented university, which
provides an exceptional and highly interactive scientific and intellectual environment, as well as
an extensive array of core laboratory and support facilities. UT Southwestern’s research faculty
include 22 members of the National Academy of Sciences, 15 members of the Howard Hughes
Medical Institute, and 6 Nobel Laureates. The university supports an extensive number of seminar
series, which routinely host outside speakers who are leaders in their fields.  In addition, individual
units and laboratories on campus support a wide variety of works-in-progress meetings and
journal clubs, which provide abundant opportunities for scientific and collaborative interactions.
The environment at UTSW is structured to encourage and support interactions between basic
scientists and clinicians. The intellectual environment in the Department, as well as in neighboring
departments and across campus, is outstanding. It provides a tremendous resource of expertise
to the PI and SUNA for potential proposed studies. Numerous investigators on campus, who
are leaders in their fields, work in areas closely related to the research interests of SUNA.
UTSW Outpatient Building FPMRS Clinic: The UTSW Female Pelvic Medicine &
Reconstructive Surgery (FPMRS) clinic is staffed by Drs. Rahn, Schaffer, Florian, and Corton, 2
FPMRS fellows, and 2 nurse practitioners. The clinic is located in a building adjacent to Clements
University Hospital. This outpatient clinic is fully equipped with 5 examination rooms and a
urodynamic laboratory. Available equipment includes a Laborie® Aquarius XLS urodynamics
system, Wolf® cystoscopy equipment, 2 portable Pathways 10 electrical stimulation units, 3
Uroplasty Urgent PC® Neuromodulation Systems, and a urodynamic chair. One bladder scanner
is present in the clinic. Physicians see patients in nine ½-day sessions per week in this clinic and
perform office diagnostic cystoscopy, periurethral bulking and Botox® injection. The nurse
practitioners see patients 5 days per week for non-surgical management, including pelvic floor
rehabilitation, pessary management, biofeedback, electrical stimulation and urodynamics. One
nurse practitioner (the PI for this proposal) is permanently housed in this clinic so that she is


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available 5 days per week for recruitment as well as treatment of patients in clinical studies.  She
conducts approximately 24-40 urodynamic bladder tests per month.  In 2013/14, 1,721 patients
were seen in the UTSW FPMRS Clinic.
Our division also participates in NIH funded multi-site clinical research trials through the
Pelvic Floor Disorders Network, providing a strong foundation in clinical research.  Research
support is available by on-site registered nurses, clinical research coordinators, &
biostatisticians, who can aid in the statistical data analysis and data entry.
The principal investigator, Christina Hegan, MS, APRN, WHNP-BC, is a current member
of the Society of Urologic Nurses & Associates (SUNA), serving as Urodynamics Special
Interest Group Leader.  She has also presented at the 2018 SUNA urologic conference
meeting, served on two patient fact sheet task forces, and recently submitted an abstract for
presentation at the 2019 SUNA urologic conference.  She has achieved several
accomplishments in the last two years, including publication of two literature reviews online
through the Interstitial Cystitis Association (ICA), three magazine articles published in the ICA
Update, and a chapter published in an international textbook.  She is currently serving as an
interventionist in three NIH funded multi-site clinical research trials through the Pelvic Floor
Disorders Network, and she has completed one phase 2 multi-site industry sponsored clinical
trial as co-investigator.
Faculty sponsor & co-investigator, Dr. Joseph Schaffer, will be an important mentor in
this project.  With his many years of experience in pelvic floor medicine and reconstructive
surgery, Dr. Schaffer has a strong record of accomplishment, producing quality based,
statistically significant, and well-designed studies.
Additionally, co-investigator Dr. David Rahn will be an integral contributor and mentor on
this project.  Dr. Rahn also has a strong record of accomplishment, including receiving a recent


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NIH grant for an investigational trial studying the role of vaginal estrogen in surgical healing.
His study may help change practice by providing substantial proof or disproof of vaginal
estrogen’s ability to aid in the healing process, which has long been speculated.
References:
1. Bump RC. The urethrodetrusor facilitative reflex in women: results of urethral perfusion
studies. Am J Obstet Gynecol 2000 Apr;182(4):794-802; discussion -4.
2. Jung SY, Fraser MO, Ozawa H, Yokoyama O, Yoshiyama M, De Groat WC, et al. Urethral
afferent nerve activity affects the micturition reflex; implication for the relationship between
stress incontinence and detrusor instability. The Journal of urology 1999 Jul;162(1):204-12.
3. Kisby CK, Gonzalez EJ, Visco AG, Amundsen CL, Grill WM. Randomized Controlled Trial to
Assess the Impact of Intraurethral Lidocaine on Urodynamic Voiding Parameters. Female
pelvic medicine & reconstructive surgery 2018 Jan 3.
4. Patel AR, Jones JS, Babineau D. Lidocaine 2% jelly versus plain lubricating jelly for pain
reduction during flexible cystoscopy: a meta-analysis of prospective, randomized, controlled
trials. The Journal of urology 2008 Mar;179(3):986-90.


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5. Ozel BZ, Sun V, Pahwa A, Nelken R, Dancz CE. Randomized controlled trial of 2% lidocaine
jelly versus water-based lubricant for multi-channel urodynamics. International
urogynecology journal 2018 Sep;29(9):1297-302.
6. Edlund, C., Peeker, R., & Fall, M. (2001). Lidocaine cystometry in the diagnosis of bladder
overactivity. Neurourol Urodyn, 20(2), 147-155.

ICF_001.pdf: 
Lessons on Urethral Lidocaine in Urodynamics (“LULU”): Impact of intraurethral lidocaine on
cystometric parameters and discomfort, a RCT
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Page 1 of 13
UTSW Research Consent and Authorization Documents (v2 Oct 2018)
DO NOT DISCLOSE
NCT04038099
03/29/2022


Lessons on Urethral Lidocaine in Urodynamics (“LULU”): Impact of intraurethral lidocaine on
cystometric parameters and discomfort, a RCT
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Page 2 of 13
UTSW Research Consent and Authorization Documents (v2 Oct 2018)
DO NOT DISCLOSE
Consent to be part of a Research Study
To be conducted at
The University of Texas Southwestern Medical Center
Key Information about this Study
This study is being conducted in order to determine whether use of intraurethral 2% lidocaine jelly meaningfully
impacts sensation during filling of the bladder with sterile water for urodynamic bladder testing and to
determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts pain/discomfort, filling
metrics, and voiding metrics during urodynamic bladder testing.  The only requirement of the study is that you
be already scheduled for  urodynamic bladder testing.  Your participation will only last for approximately 90
minutes or however long it takes to complete the urodynamics bladder test.
There is no guarantee or promise that you will receive any benefit from this study.  The investigators have
designed this study to learn how well the new treatment (2% lidocaine jelly) compares to commonly accepted
treatment (a plain lubricant for catheter insertion).  In usual standard of care urodynamic bladder testing, you
would not receive any anesthetic for pain relief.
There are risks to taking part in this research study.  One risk is that you may have side effects while on the
study.  Side effects from this study will usually go away soon after the procedure and/or administration of 2%
lidocaine jelly. There is a risk that the effectiveness and/or safety of the treatment for the 2% lidocaine jelly
group may not be an effective anesthetic for urodynamic bladder testing.  You may get a treatment or drug that
does not minimize discomfort during the procedure.
We hope the information learned from this study will benefit other patients.  If we learn that the use of 2%
lidocaine jelly makes this procedure more comfortable for women without affecting test results, this could be
very useful for women undergoing urodynamic bladder testing in the future.
Information about this form
You may be eligible to take part in a research study.  This form gives you important information about the
study.
Please take time to review this information carefully.  You should talk to the researchers about the study and
ask them any questions you have.  You may also wish to talk to others (for example, your friends, family, or a
doctor) about your participation in this study.  If you decide to take part in the study, you will be asked to sign
this form.  Before you sign this form, be sure you understand what the study is about, including the risks and
possible benefits to you.
Please tell the researchers or study staff if you are taking part in another research study.
Your provider is a research investigator in this study.  S/he is interested in both your medical care and the
conduct of this research study.  At any time, you may discuss your care with another doctor who is not part of
this research study.  You do not have to take part in any research study offered by your doctor.
Voluntary Participation - You do not have to participate if you don't want to.  You may also leave the study at
any time.  If you decide to stop taking part in this research study, it will not affect your relationship with the UT
Southwestern staff or doctors.  Whether you participate or not will have no effect on your legal rights or the
quality of your health care.


Lessons on Urethral Lidocaine in Urodynamics (“LULU”): Impact of intraurethral lidocaine on
cystometric parameters and discomfort, a RCT
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If you are a medical student, fellow, faculty, or staff at the Medical Center, your status will not be affected in
any way.
General Information – “Who is conducting this research?”
Principal Investigator
The Principal Investigator (PI) is the researcher directing this study; the PI is responsible for protecting your
rights, safety and welfare as a participant in the research.  The PI for this study is Christina Hegan, MS, APRN,
WHNP-BC, Department of Obstetrics & Gynecology, Division of Female Pelvic Medicine & Reconstructive
Surgery at The University of Texas Southwestern Medical Center.
Funding
The Society of Urologic Nurses & Associates, a non-profit organization that promotes scientific research, is
funding this study.  This organization is providing money to The University of Texas Southwestern Medical
Center so that the researchers can conduct the study.
Purpose – “Why is this study being done?”
You are being asked to participate in this research study on the use of a numbing cream (called 2% lidocaine
jelly) placed in your urethra during urodynamic bladder testing to determine if its use makes any important
differences in your ability to sense bladder fullness, empty your bladder effectively, and if it improves
discomfort during the testing. Currently, urodynamic bladder testing is not performed with any local anesthetic,
such as 2% lidocaine jelly, because it is unknown whether or not it may affect test results or provide
meaningful improvement in patient discomfort with testing.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most, the Web site will include a summary of the
results. You can search this Web site at any time.
Information about Study Participants – “Who is participating in this research?”
You are being asked to be a participant in this study because you are already being scheduled for urodynamic
bladder testing.
This study will enroll approximately 70 study participants.
Information about Study Procedures – “What will be done if you decide to be in the research?”
While you are taking part in this study, you will be asked to attend approximately 1 visit with the researchers or
study staff.
Screening – After you sign this consent to participate, exams, tests, and/or procedures may be done as
described below to find out if you can continue in the study; this is called screening. We may be able to use the
results of exams, tests, and/or procedures you completed before enrolling in this study.  You will be told which
results we will obtain and which procedures will not have to be repeated.  Many of the procedures are
described below as “standard care” and would be done even if you do not take part in this research study.
You will be told which ones are for “research only”.


Lessons on Urethral Lidocaine in Urodynamics (“LULU”): Impact of intraurethral lidocaine on
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Screening Procedures
 
If you are capable of becoming pregnant, a pregnancy test will also be done before you receive study
treatment.
This visit will take approximately 1.5-2 hours.
Assignment to Study Groups –
When it is determined that you are eligible for the study, you will be assigned by chance (like flipping a coin to
one of two study groups.
 
Placebo (Water Based Lubricant Jelly)
 
Active Treatment (2% Lidocaine Jelly)
You will have a one in two chance of being in the placebo group. A placebo is an inactive, harmless substance
that looks like the other study drugs.
Neither you nor the researchers will know whether you are receiving the study drug or a placebo.  In the event
of an emergency, there is a way for the researcher to find out which you are receiving.
Study Procedures - as a participant, you will undergo the following procedures:
Urodynamic Bladder Testing
Urodynamic bladder testing is a simple clinical procedure that assesses how well your bladder and
urethra are able to store and release urine.  This is an outpatient exam and helps your provider better
understand and diagnose health issues.  It is not a corrective procedure.
What to expect: This is a relatively painless test, although some patients do experience discomfort from
the catheter insertion.
Measuring Flow Rate (Uroflometry):
 
To begin the test, you will sit on a special procedure chair and urinate into a funnel,
which will measure the flow rate of your stream.
 
The nurse practitioner will then clean your urethra, the tube that connects our bladder to
the outside of the body, and empty your bladder using a catheter (sterile plastic tubing)
to ensure the bladder is completely empty and to obtain a sample for infection testing.

This is standard care.
Measuring Bladder and Abdominal Pressure:
 
If the urine is free of infection, the nurse practitioner will place a small pediatric catheter
into the urethra and use it to fill your bladder with sterile water and, at the same time,
measure the pressure inside your bladder.
 
The nurse practitioner will place another small pediatric catheter in either your vagina or
rectum, depending on the presence of uterovaginal prolapse or vaginal vault prolapse
and the degree of prolapse present.


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 
If there is prolapse present, large cotton swabs called “scopettes” may be placed in the
vagina to hold the prolapse up and simulate what surgery would do to provide support to
the uterus and/or vagina.
 
Two self-adherent wired patches that measure your pelvic floor muscles’ electrical
activity (“electromyography”, or EMG) will be placed on the skin between your thighs
near your anus.

This is standard care.
Measuring Urinary Stress Leakage (Cystometrogram, Leak Point Pressure, & Pressure Flow Study):
 
The nurse practitioner will attach the catheters and EMG patch electrode wires to the
computer and begin filling your bladder with sterile water.
 
You will be requested to inform the practitioner when you initially feel the sensation of
water in your bladder, the first urge to urinate, a strong urge to urinate, and when you
feel you have reached your full bladder capacity.
 
During this portion of the test, the nurse practitioner will be asking you to do some
exercises by bearing down and coughing at different strengths of force and at different
intervals throughout the procedure.  This is to assess for urinary stress leakage and the
pressure and volume indicated to evoke incontinence.
 
After you have reached your bladder capacity, the nurse practitioner will ask you to
urinate and empty your bladder.  You should be able to void around the pediatric
catheters.  The computer will capture the amount you void, as well as your maximum
flow rate, the electrical activity of your pelvic floor muscles, and the pressure of your
abdomen, bladder, and detrusor while you void.

This is standard care.
 
For the research study, you will be asked to complete a pain scale (called a “visual
analog scale”) ranging from 0 to 100 mm during catheter insertion, at maximum bladder
capacity, at the time of voiding, and once the procedure is completed.
Research Study
 
At this point in the study, you will be randomized to either placebo (water based
lubricant) or active treatment (2% lidocaine jelly)
 
5cc of either placebo or active treatment will be placed into the urethra using a plastic
soft-tipped syringe (i.e., without a needle).
 
You will sit for 5 minutes to allow the medication to take effect, if applicable.
 
The small catheter is then replaced, and the cystometrogram & pressure flow study tests
are repeated, taking the same measurements as above.
 
You will be asked to repeat the pain scale again during catheter insertion, at maximum
capacity, during voiding, and after the procedure is complete.
Measuring Closing Pressure of Urethra
 
After you empty your bladder, the nurse practitioner will fill your bladder with sterile water
again to approximately 200ml and hook the urethral catheter up to another device, which
will help measure the closing pressure of your urethra, length of your urethra, and area
of continence.  The device will gently pull the catheter in and out of the urethra
approximately three times to obtain an accurate average of measurements.
 
The practitioner will then remove all catheters and scopettes.  If you were unable to void
at least 200ml of urine on the initial uroflometry test, the nurse practitioner may ask you
to void in the procedure chair again to try to obtain another uroflometry test reading.


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
This is standard care.
Could your participation end early? There are several reasons why the researchers may need to end your
participation in the study (early withdrawal).  Some reasons are:
 
The researcher believes that it is not in your best interest to stay in the study.
 
You become ineligible to participate.
 
Your condition changes and you need treatment that is not allowed while you are taking part in the study.
 
You do not follow instructions from the researchers.
 
The study is stopped.
The researchers will discuss your options for medical care when your participation in this study ends.
It is possible that this study will identify information about you that was previously unknown, such as disease
status or risk.  There are no plans to provide this information to you or your physician.
Risks – “What are the risks of participation in the research?”
Risks from the research
The investigators have designed this study to learn how well the new treatment (2% lidocaine jelly) compares
to commonly accepted treatment (a plain lubricant for catheter insertion).  In usual standard of care
urodynamic bladder testing, you would not receive any anesthetic for pain relief.  There is a risk that the
effectiveness and/or safety of the treatment for the 2% lidocaine jelly group may not be an effective anesthetic
for urodynamic bladder testing.  You may get a treatment or drug that does not minimize discomfort during the
procedure.
Risks from the specific research procedures (drug(s), interventions, or procedures)
There are risks to taking part in this research study.  One risk is that you may have side effects while on the
study.
Side effects from this study will usually go away soon after the procedure and/or administration of 2% lidocaine
jelly.
Everyone taking part in the study will be watched carefully for any side effects.  However, the study doctors
don’t know all the side effects that may happen.  Be sure to tell your study doctor immediately about any side
effect that you have while taking part in the study.
The following section will describe the risks related to your participation in this research study.  You should talk
to your study doctor about any side effects or other problems that you have while taking part in the study.
Side effects can range from mild to serious.  Serious side effects are those that may require hospitalization, are
life threatening or fatal (could cause death).  The frequency that people experience a certain side effect can
range from many (likely), few (less likely) or only one or two (rarely).
Risks and side effects for procedure and medication are as follows:
Urodynamic Bladder Testing


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Urodynamic bladder testing requires that participants receive a bladder catheterization as standard care.
Bladder catheterization involves placing a catheter into the bladder in order to remove urine and fill the bladder
with sterile water.  A rare and uncommon risk is potential for urinary tract infection.  You will receive one dose
of oral antibiotic after the procedure in order to prevent an infection. This is standard care.  If an infection
occurs, the infection will be treated with a few days of oral antibiotics.  Additionally, you may feel bladder or
urethral discomfort, including burning and stinging urethral sensations, and urinary urgency and/or urinary
frequency due to irritation from the catheter at the time of placement and with bladder filling.  These
uncomfortable sensations should not last more than a few hours.  You will also be offered one dose of oral
bladder analgesic (pain reliever) at the end of the procedure and study. This is standard care.
Other rare, but serious risks include the occurrence of autonomic dysreflexia, which is a medical emergency
that occurs with uncontrolled blood pressure and heart rate; typically this is only ever seen in patients with
spinal injuries and lesions.  This study is not planned for patients with neurogenic disease who have this
potential risk for occurrence of autonomic dysreflexia.  If this occurs, it would occur in the setting of
undiagnosed and unknown neurogenic disease.  If this occurs, the catheter will be removed, and a larger
catheter will be used to immediately drain the bladder, which usually helps resolve the reaction.  If needed,
nitroglycerin paste will be applied to the chest in order to stabilize vital signs and appropriate critical care will
be provided.
2% Lidocaine Jelly
Although 2% lidocaine jelly is poorly absorbed through the urethra and bladder, you may theoretically
experience some systemic side effects. Side effects that have been reported by some patients using lidocaine
for various medical reasons include lightheadedness, nervousness, apprehension, euphoria, confusion,
dizziness, drowsiness, tinnitus (ringing in the ears), blurred or double vision, nausea, vomiting, sensations of
heat, cold or numbness, twitching, tremors, low blood pressure, urethral irritation, or tingling sensation. Rare,
but serious side effects include unconsciousness, respiratory depression, irregular heart rhythms, heart attack,
cardiac arrest, methemoglobinemia (a serious condition where the blood is less able to carry oxygen to the
tissues of the body), or seizures. Allergic reactions to lidocaine are incredibly rare but may occur.  Allergic
reactions may manifest as skin lesions, itching, redness of the skin, swelling, or anaphylaxis, a medical
emergency requiring immediate intervention. This is study is contraindicated in patients with known sensitivity
or allergy to lidocaine or local anesthetics.  If this occurs, it would occur in the setting of an undiagnosed and
unknown sensitivity or allergy.
Due to the investigational nature of this study, there may be other risks that are currently unknown.
For more information about risks and side effects, ask one of the researchers or study staff.
We will tell you about any significant new findings which develop during the course of this research which may
relate to your willingness to continue taking part.
Are there Risks related to withdrawing from the study?
If you decide to withdraw from this study early, please discuss your decision with the principal investigator.
The researcher may ask you to complete study withdrawal procedures at a final study visit.  This visit may
include answering questions regarding withdrawal and addressing potential reasons for withdrawal, as well as
the potential need for physical examination in the event of any adverse event. There is no risk to you if you do
not complete the final withdrawal procedures and you can choose not to participate in them.


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Reproductive Risks -
Concerns for sexually active women: If it is possible you could be pregnant, you should not take part in this
study because we do not know how the study drugs/procedures could affect a fetus.  If you discover later that
you were pregnant while taking part in this study, tell one of the study doctors right away so that management
of the pregnancy can be discussed.
If you are a woman who is pregnant or could be pregnant, you cannot take part in this study because we do
not know how the urodynamic bladder testing and/or 2% lidocaine jelly might affect a developing fetus.  We will
do a pregnancy test before you start treatment to make sure you are not pregnant.
If you learn that you likely were pregnant during your participation in this research study, the researchers would
like to collect follow-up information regarding your pregnancy.
Risks to babies who are being breastfed:   Women who are breastfeeding cannot take part in this study
because we do not know what effect the drugs/procedures might have on their breast milk.
Are there risks if you also participate in other research studies?
Being in more than one research study at the same time, or even at different times, may increase the risk to
you.  It may also affect the results of the studies.  You should not take part in more than one study without
approval from the researchers.
What if a research-related injury occurs?
The researchers have taken steps to minimize the known or expected risks.  However, you may still
experience problems or side effects, even though the researchers are careful to avoid them.  In the event of a
research-related injury or if you experience an adverse reaction, please immediately contact your study doctor.
See the section “Contact Information” for phone numbers and additional information.  You may also need to tell
your regular doctors.
If you are injured or made sick from taking part in this research study, medical care will be provided. This care
may be billed to you or your insurance. Depending on the circumstances, this care may be provided at no cost
to you. We have no plans to give you money if you are injured. The investigator can provide you with more
information.
If you sign this form, you do not give up your right to seek additional compensation if you are harmed as a
result of being in this study.
Benefits – “How could you or others benefit from your taking part in this study?”
There is no guarantee or promise that you will receive any benefit from this study.
We hope the information learned from this study will benefit other patients.  If we learn that the use of 2%
lidocaine jelly makes this procedure more comfortable for women without affecting test results, this could be
very useful for women undergoing urodynamic bladder testing in the future.
Alternative procedures or course of treatment – “What other options are there to participation in this
study?”
There are other options available to you.  Your other choices may include:
Proceeding with urodynamic bladder testing without participation in the study.


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Payments – Will there be any payments for participation?
You will receive a $100.00 stipend for your participation in the study.  You will be issued a UT Southwestern
Greenphire ClinCard, which can be used as a credit or debit card.  Compensation will be credited to the card
after completion of the study visit.  Your name, address, date of birth and social security number will be shared
with a third-party solely for the purposes of compensation processing. All information will be stored in a secure
fashion.
Please note that if you are on record as owing money to the State of Texas, such as for back child support or a
delinquent student loan, the payment may be applied to that debt.
An IRS Form 1099 will be sent to you if your total payments are $600 or more in a calendar year, unless it’s a
reimbursement.
Costs – Will taking part in this study cost anything?
You or your health insurance company will be responsible for the cost of treatments and procedures that would
be done whether or not you took part in this study, such as the urodynamic bladder testing, including urine
analysis for infection, abdominal pressure test, uroflometry, cystometrogram, leak point pressure test, pressure
flow study, and urethral pressure profile test.  It is important to understand that some insurance companies do
not cover some costs (for example, approved drugs used in a way different from the package instructions). If
your insurance company does not cover these treatments or procedures performed as standard care, you will
still be required to pay for them.
Ask the researchers if you have any questions about what it will cost you to take part in this study (for example
bills, fees, or other costs related to the research).
The sponsor will provide the study drug free of charge during this study.  There is no cost to you for the
repeated cystometrogram and pressure flow study that are completed as research procedures.
Confidentiality – How will your records be kept confidential?
Information we learn about you in this study will be handled in a confidential manner, within the limits of the
law.  If we publish the results of the study in a scientific journal or book, we will not identify you.  The
Institutional Review Board and other groups that have the responsibility of monitoring research may want to
see study records which identify you as a subject in this study.
Certificate of Confidentiality:
To help us further protect your information, the investigators will obtain a Certificate of Confidentiality from the
U.S. Department of Health and Human Services (DHHS).  This Certificate adds special protections for
research information that identifies you and will help researchers protect your privacy.
With this Certificate of Confidentiality, the researchers cannot be forced to disclose information that may
identify you in any judicial, administrative, legislative, or other proceeding, whether at the federal, state, or local
level.  There are situations, however, where we will voluntarily disclose information consistent with state or
other laws, such as:
 
to DHHS for audit or program evaluation purposes;


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 
information regarding test results for certain communicable diseases to the Texas Department of State
Health Services, including, but not limited to HIV, Hepatitis, Anthrax, and Smallpox;
 
if you pose imminent physical harm to yourself or others;
 
if you pose immediate mental or emotional injury to yourself;
 
if the researchers learn that a child has been, or may be, abused or neglected; or
 
if the researchers learn that an elderly or disabled person has been, or is being, abused, neglected or
exploited.
The Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing
information about your involvement in this research study.  In addition, the researchers may not use the
Certificate to withhold information about your participation in this research study if you have provided written
consent to anyone allowing the researchers to release such information (including your employer or an
insurance company).  This means that you or your family must also actively protect your privacy.
A Certificate of Confidentiality does not represent an endorsement of this research project by the Department
of Health & Human Services or any other Federal government agency.
Research policies require that private information about you be protected and this is especially true for your
health information.  However, the law sometimes allows or requires others to see your information.  The
information given below describes how your privacy and the confidentiality of your research records will be
protected in this study. Medical information collected during this study and the results of any test or procedure
that may affect your medical care may be included in your medical record. The information included in your
medical record will be available to health care providers and authorized persons including your insurance
company.
What is Protected Health Information (PHI)?
Protected Health Information is information about a person’s health that includes information that would make it
possible to figure out whose it is.  According to the law, you have the right to decide who can see your
protected health information.  If you choose to take part in this study, you will be giving your permission to the
investigators and the research study staff (individuals carrying out the study) to see and use your health
information for this research study.  In carrying out this research, the health information we will see and use
about you will include:
 
Medical History
 
Information that we get from your medical record.
 
Information contained in your medical records related to your medical history and treatments prior to
the study.
 
Information that is collected during your participation in the study including medical and treatment
history.
 
Information that you give us during your participation in the study, such as continuous pain scales
(visual analog scales).
 
Demographic information, such as your age, marital status, employment, and level of education, etc.
We will get this information by asking you and looking at your medical records.
How will your PHI be shared?
Because this is a research study, we will be unable to keep your PHI completely confidential.  We may share
your health information with people and groups involved in overseeing this research study including:
 
the Sponsor, Society of Urologic Nurses & Associates, funding the study. The sponsor includes any
people, entities, groups or companies working for or with the sponsor or owned by the sponsor.  The


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sponsor will receive written reports about your participation in the research. The sponsor may look at your
health information to assure the quality of the information used in the research.
 
the members of the local research team.
 
The Institutional Review Board, Human Research Protection Program Office and the Compliance Office of
the University of Texas Southwestern Medical Center, and other groups that oversee how research studies
are carried out.
 
The Research offices at University of Texas Southwestern Medical Center.
 
the Food and Drug Administration (FDA) and other U.S. and international governmental regulatory
agencies involved in overseeing drug or device research.
 
Representatives of domestic and foreign governmental and regulatory agencies may be granted direct
access to your health information for oversight, compliance activities, and determination of approval for
new medicines, devices, or procedures.
If you decide to participate in this study, you will be giving your permission for the groups named above, to
collect, use and share your health information.  If you choose not to let these groups collect, use and share
your health information as explained above, you will not be able to participate in the research study.
Parts of your PHI may be photocopied and sent to a central location or it may be transmitted electronically,
such as by e-mail or fax. The groups receiving your health information may not be obligated to keep it private.
They may pass information on to other groups or individuals not named here
How will your PHI be protected?
In an effort to protect your privacy, the study staff will use code numbers instead of your name, to identify your
health information.  Initials and numbers will be used on any photocopies of your study records, and other
study materials containing health information that are sent outside of the UT Southwestern Division of Female
Pelvic Medicine & Reconstructive Surgery clinic for review or testing.  If the results of this study are reported in
medical journals or at meetings, you will not be identified.
Do you have to allow the use of your health information?
You do not have to allow (authorize) the researchers and other groups to see and share your health
information.  If you choose not to let the researchers and other groups use your health information, there will
be no penalties but you will not be allowed to participate in the study.
After you enroll in this study, you may ask the researchers to stop using your health information at any time .
However, you need to say this in writing and send your letter to Christina Hicks, MS, APRN, WHNP-BC, UT
Southwestern Medical Center, 5323 Harry Hines Blvd. Dallas, TX 75390-8539.  If you tell the researchers to
stop using your health information, your participation in the study will end and the study staff will stop collecting
new health information from you and about you for this study.  However, the study staff will continue to use the
health information collected up to the time they receive your letter asking them to stop.
Can you ask to see the PHI that is collected about you for this study?
The federal rules say that you can see the health information that we collect about you and use in this study.
Contact the study staff if you have a need to review your PHI collected for this study.
You will only have access to your PHI until December 31, 2021.
How long will your PHI be used?
By signing this form, you agree to let us use and disclose your health information for purposes of the study until
the end of the study.  This permission to use your personal health information expires when the research ends
and all required study monitoring is over.


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Contact Information – Who can you contact if you have questions, concerns, comments or
complaints?
If you have questions now, feel free to ask us.  If you have additional questions, concerns, comments or
complaints later or you wish to report a problem which may be related to this study, please contact: Christina
Hicks, MS, APRN, WHNP-BC.
Primary contact:
Christina Hicks, MS, APRN, WHNP-BC can be reached at 214-645-3848.
If primary is not available, contact
Agnes Burris, RN Clinical Research Coordinator, can be reached at 214-645-3833.
The University of Texas Southwestern Medical Center Human Research Protection Program (HRPP) oversees
research on human subjects.  HRPP and Institutional Review Board (IRB) representatives will answer any
questions about your rights as a research subject, and take any concerns, comments or complaints you may
wish to offer.  You can contact the HRPP by calling the office at 214-648-3060.


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Research Consent & Authorization Signature Section
If you agree to participate in this research and agree to the use of your protected health information in this
research, sign this section.  You will be given a copy of this form to keep.  You do not waive any of your legal
rights by signing this form.
SIGN THIS FORM ONLY IF THE FOLLOWING STATEMENTS ARE TRUE:
 
You have read (or been read) the information provided above.
 
Your questions have been answered to your satisfaction about the research and about the collection,
use and sharing of your protected health information.
 
You have freely decided to participate in this research or you are voluntarily giving your consent for
another person to participate in this study because you believe this person would want to take part if
able to make the decision and you believe it is in this person’s best interest.
 
You understand that a copy of this signed consent document, information about this study, and the
results of any test or procedure that may affect your medical care, may be included in your medical
record. Information in your medical record will be available to health care providers and authorized
persons including your insurance company.
 
You authorize the collection, use and sharing of your protected health information (another person’s
protected health information) as described in this form.
Adult Signature Section
AM
PM
Printed Name of Participant
Signature of Participant
Date
Time
AM
PM
Printed Name of Person
Obtaining Consent
Signature of Person Obtaining
Consent
Date
Time