Clinical trial NCT04124939
Conditions: Overactive Bladder
Keywords: Overactive Bladder Botox/OnabotulinumtoxinA Pain OAB Non-neurogenic Overactive bladder
Sponsor: Wake Forest University Health Sciences
Start date: 2019-11-10; Completion date: 2023-02-23
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to help determine if 10 injections of Botox ® 100 units is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse outcomes of 20 injections versus 10 injections.

Detailed description:
This study is a randomized clinical trial to assess whether or not 10 injections of 100 units of intradetrusor Botox® toxin is perceived as less painful compared to 20 injections of 100 units of intradetrusor Botox® toxin for the treatment of refractory overactive bladder.

Arms: arm 1: 100 units of Botox® (onabotulinumtoxinA) will be combined with 10 cc of sterile saline for the purpose of 10 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone. arm 2: 100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.
Interventions: intervention 1: OnabotulinumtoxinA 100 Units
Intervention descriptions: intervention 1: BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:

• Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Protocol documents:
ICF_002.pdf: 
Official Title:  A Randomized Clinical Trial of 100 Units of Intradetrusor 
Onabotulinum Toxin A for Refractory Overactive Bladder - Is 10 Injections Less 
Painful Than 20 Injections?  
NCT04124939
IRB-Approved Date: 7/12/2022


Page 1 of 9
Adult Consent Form
IRB Template Version 12/14/2018
A RANDOMIZED CLINICAL TRIAL OF 100 UNITS OF INTRADETRUSOR 
ONABOTULINUM TOXIN A FOR REFRACTORY OVERACTIVE BLADDER - IS 
10 INJECTIONS LESS PAINFUL THAN 20 INJECTIONS? 
Informed Consent Form to Participate in Research
Catherine Matthews, MD Principal Investigator
SUMMARY
You are invited to participate in a research study. The purpose of this research is to help 
determine if 100 units of Botox ® distributed in 10 injections to treat refractory overactive 
bladder is less painful than 20 injections.  You are invited to be in this study because you have 
decided to undergo treatment of your overactive bladder with Botox ®. Your participation in this 
research will involve 4 visits and last about 3 months. 
Participation in this study will involve you receiving the current United States Food and Drug 
Administration (FDA) recommended dose of Botox ® which is 100 units. However, you will 
either receive this dose in 10 injections or 20 injections based on randomization.  All research 
studies involve some risks.  A risk to this study that you should be aware of is the risk of urinary 
tract infections, urinary retention, and that this therapy may not work for you. These risks apply 
whether or not you participate in the study.  You may or may not receive benefit by participating 
in this study. .  
Your participation in this study is voluntary.  You do not have to participate in this study if you 
do not want to.  There may be other choices available to you.  Some other choices may include 
receiving Botox 100 units in the amount of injections determined by your provider’s standard 
practice.  You will not lose any services, benefits, or rights you would normally have if you 
choose not to participate. 
The remainder of this form contains a more complete description of this study. Please read this 
description carefully. You can ask any questions if you need help deciding whether to join the 
study. The person in charge of this study is Catherine Matthews, MD, the principle investigator 
of this study and Whitney Smith, MD, co-investigator. If you have questions, suggestions, or 
concerns regarding this study or you want to withdraw from the study her contact information is: 
. 
If you have any questions, suggestions or concerns about your rights as a volunteer in this 
research, contact the Institutional Review Board at 
 or the Research Subject 
Advocate at Wake Forest at 
.
Department of Urology
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00059454
Meeting Date Approved 7/12/2022          
Version Valid Until: 7/11/2023


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Adult Consent Form
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INTRODUCTION
You are invited to be in a research study. Research studies are designed to gain scientific 
knowledge that may help other people in the future. You are being asked to take part in this 
study because you have refractory overactive bladder. Your participation is voluntary. Please 
take your time in making your decision as to whether or not you wish to participate. Ask your 
study doctor or the study staff to explain any words or information contained in this informed 
consent document that you do not understand. You may also discuss the study with your friends 
and family.
WHY IS THIS STUDY BEING DONE?
The purpose of this research study is to help determine if 10 injections of Botox ® 100 units is 
less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing urge 
incontinence episodes. We will also assess the pain of procedure and adverse outcomes of 20 
injections versus 10 injections.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
40 people will take part in this study.
WHAT IS INVOLVED IN THE STUDY?
At your first visit, you will have a baseline post void residual (the amount of urine left in your 
bladder after you have emptied it in the restroom) measured by a bladder scanner (a portable 
ultrasound machine that will determine how much urine is left in your bladder), urinalysis (a 
urine sample test looking for abnormal conditions such as infection or blood in the urine), fill out 
a form to determine if you are eligible to participate in the study), complete a 3 day bladder diary 
at home as a part of standard procedure; that is you return a completed diary which was provided 
to you during your last visit and before deciding upon participation in this study, and complete a 
questionnaire regarding how bothersome your overactive bladder is to you.
At your second visit, you will undergo injections of Botox ® into your bladder through a 
cystoscope (an instrument used to visualize the inside of the bladder). Prior to doing this, again 
we will use the urinalysis to see if you have a urinary tract infection. At this visit you will be 
randomized to receive either 10 injections or 20 injections of a total 100 Units of Botox ® which 
is the dose recommended by the FDA. You will also fill out a form asking you to rate the pain of 
procedure.
At your third visit 2 weeks after your procedure, you will have your post void residual and 
urinalysis checked. You will fill out 3 forms to assess your level of bother from overactive 
bladder, how is it affecting your quality of life, and if you have had any complications such as 
urinary tract infection or urinary retention. You will be provided a 3 day bladder diary, which 
you will start updating 3 days in advance to complete before the last (4th) visit. You will be 
requested to bring the completed diary during your 4th (last) visit.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00059454
Meeting Date Approved 7/12/2022          
Version Valid Until: 7/11/2023


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Adult Consent Form
IRB Template Version 12/14/2018
At your fourth visit 12 weeks after your procedure, you will have your post void residual and 
urinalysis checked. You will fill out 3 forms to assess your level of bother from overactive 
bladder, how is it affecting your quality of life, and if you have had any complications such as 
urinary tract infection or urinary retention. You will be required to complete a 3 day bladder 
diary at home, and you will fill out a form for the completion of the study.
You will be randomized into one of the study groups described below. Randomization means 
that you are put into a group by chance. It is like flipping a coin. You will have an equal chance 
of being placed in any group.
You will either fall in a group of study patients who receives 10 injections, or 20 injections. 
Study team opens an envelope before the procedure, which will have information whether you 
will be receiving 10 injections or 20. You will not be informed the group you are in to avoid any 
effect on your selection for the post procedural pain rate. During the procedure, one provider will 
count up to 20. If you are in a group of subjects receiving 10 injections, then you will not receive 
an injection at either an odd or even count from 1 to 20. You will also not be able to view the 
procedure on the monitor – the display will be turned in a way where only the provider and study 
staff will be able to see.
HOW LONG WILL I BE IN THE STUDY?
You will be in the study for about 12 weeks.
You can stop participating at any time. If you decide to stop participating in the study we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences. Currently, there are no serious consequences for withdrawing early from 
the study.
WHAT ARE THE RISKS OF THE STUDY?
Being in this study involves some risk to you. You should discuss the risk of being in this study 
with the study staff. Risks and side effects related to the procedures and drug we are studying 
include:
This study is comparing two approved methods for treating your condition. You will be 
randomly assigned to one of the two groups. It is possible that one treatment group may have a 
better response than the other. Therefore there is a risk that you may be assigned to a group that 
does not perform as well as its comparison.
The risks associated with this study are the risks associated with this procedure in general. There 
is a risk that you may not be able to empty your bladder completely requiring the use of 
catheterization, urinary tract infection requiring a course of antibiotics, allergic reactions, and 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00059454
Meeting Date Approved 7/12/2022          
Version Valid Until: 7/11/2023


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Adult Consent Form
IRB Template Version 12/14/2018
difficulty breathing and swallowing. Allergic reactions and difficulty breathing and swallowing 
are rare. The risk that you may require a catheter to empty your bladder or have a urinary tract 
infection is approximately 5%. These reactions are not permanent. There is also the potential that 
this treatment may not be effective for you. These risks are the same if you chose to participate 
in this study or not.
In addition, there is a slight risk of a breach of confidentiality.  We will do our best to protect 
your confidential information.  There also may be other side effects that we cannot predict. You 
should tell the research staff about all the medications, vitamins and supplements you take and 
any medical conditions you have. This may help avoid side effects, interactions and other risks. 
Taking part in this research study may involve providing information that you consider 
confidential or private.  Efforts, such as coding research records, keeping research records secure 
and allowing only authorized people to have access to research records, will be made to keep 
your information safe.
Reproductive Risks and other Issues to Participating in Research
Due to unknown risks and potential harm to the unborn fetus, sexually active women of 
childbearing potential must use a reliable method of birth control while participating in this 
study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, 
intrauterine device (IUD), Depo Provera, tubal ligation, or vasectomy of the partner (with 
confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, 
although less reliable, method involves the careful use of condoms and spermicidal foam or gel 
and/or a cervical cap or sponge. We encourage you to discuss this issue further with your 
physicians if you have any questions.
Pregnant women are excluded from participation in this study. Because some methods of birth 
control are not 100% reliable, a pregnancy test is required at least 10 days from your last normal 
menstrual period, if you are a sexually active woman of childbearing potential.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
You may or may not receive  benefit from taking part in this research study. We hope the 
information learned from this study will benefit other people in the future.
WHAT OTHER CHOICES ARE THERE?
You do not have to be in this study to receive treatment. You should talk to your doctor about all 
the choices you have. Instead of being in this study, you have these options:
You could be treated with Botox ® 100 units even if you do not take part in the study. The 
number of injections administered will be determined by your individual provider. 
If you chose not to use Botox ® 100 units all together, the other options for treating refractory 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00059454
Meeting Date Approved 7/12/2022          
Version Valid Until: 7/11/2023


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IRB Template Version 12/14/2018
overactive bladder include sacral neuromodulation or percutaneous tibial nerve stimulation.
WHAT ARE THE COSTS?
All study costs will be paid for by the study. Costs for your regular medical care, which are not 
related to this study, which include BOTOX injections, will be your own responsibility.
WILL YOUR RESEARCH RECORDS BE CONFIDENTIAL?
The results of this research study may be presented at scientific or medical meetings or published 
in scientific journals.  Your identity and/or your personal health information will not be disclosed 
unless it is authorized by you, required by law, or necessary to protect the safety of yourself or 
others.  There is always some risk that even de-identified information might be re-identified. 
Participant information may be provided to Federal and other regulatory agencies as required.  
The Food and Drug Administration (FDA), for example, may inspect research records and learn 
your identity if this study falls within its jurisdiction. 
WILL YOU BE PAID FOR PARTICIPATING?
You will receive no payment or other compensation for taking part in this study.
The findings from this research may result in the future development of products that are of 
commercial value. There are no plans to provide you with financial compensation or for you to 
share in any profits if this should occur.
WHO IS SPONSORING THIS STUDY?
This study is being sponsored by Wake Forest Baptist Health Department of Urology. The 
sponsor is providing money or other support to Wake Forest University Health Sciences to help 
conduct this study. The researchers do not, however, hold a direct financial interest in the 
sponsor or the product being studied.
WHAT HAPPENS IF YOU EXPERIENCE AN INJURY OR ILLNESS AS A 
RESULT OF PARTICIPATING IN THIS STUDY?
Should you experience a physical injury or illness as a direct result of your participation in this 
study, Wake Forest University School of Medicine maintains limited research insurance 
coverage for the usual and customary medical fees for reasonable and necessary treatment of 
such injuries or illnesses. To the extent research insurance coverage is available under this policy 
the reasonable costs of these necessary medical services will be paid, up to a maximum of 
$25,000. Wake Forest University Baptist Medical Center holds the insurance policy for this 
coverage. It provides a maximum of $25,000 coverage for each claim and is limited to a total of 
$250,000 for all claims in any one year. The Wake Forest University School of Medicine, and 
the North Carolina Baptist Hospitals, Incorporated do not assume responsibility to pay for these 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00059454
Meeting Date Approved 7/12/2022          
Version Valid Until: 7/11/2023


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medical services or to provide any other compensation for such injury or illness. Additional 
information may be obtained from the Medical Center’s Director of Risk and Insurance 
Management, at 
.
If you are injured, the insurer may require information such as your name, social security 
number, and date of birth in order to pay for your care.  This is because the insurer is required by 
law to report any payments made to cover the care of any persons who are members of a 
government insurance plan to the Department of Health and Human Services.
You do not give up any legal rights as a research participant by signing this consent form. For 
more information on medical treatment for research related injuries or to report a study related 
illness, adverse event, or injury you should call Drs. Catherine Matthews (principle investigator) 
or Whitney Smith (research study co-investigator) at 
, 24 hours a day and 7 days a 
week.
WHAT ABOUT MY HEALTH INFORMATION?
In this research study, any new information we collect from you and/or information we get from 
your medical records or other facilities about your health or behaviors is considered Protected 
Health Information. The information we will collect for this research study includes: postvoid 
residual measurement, urinalysis, bother and quality of life questionnaires pertaining to 
overactive bladder, pain of procedure, bladder diaries, and adverse reactions to Botox ®.
If this research study involves the diagnosis or treatment of a medical condition, then Protected 
Health Information collected from you during this study will be placed in your medical record, 
and may be used to help treat you, arrange payment for your care, or assist with Medical Center 
operations.
We will make every effort to keep your Protected Health Information private. We will store 
records of your Protected Health Information in a cabinet in a locked office or on a password 
protected computer. 
Your personal health information and information that identifies you (“your health information”) 
may be given to others during and after the study. This is for reasons such as to carry out the 
study, to determine the results of the study, to make sure the study is being done correctly, to 
provide required reports and to get approval for new products.  
Some of the people, agencies and businesses that may receive and use your health information 
are the research sponsor; representatives of the sponsor assisting with the research; investigators 
at other sites who are assisting with the research; central laboratories, reading centers or analysis 
centers; the Institutional Review Board; representatives of Wake Forest University Health 
Sciences and North Carolina Baptist Hospital; representatives from government agencies such as 
the Food and Drug Administration (FDA) or the Office of Human Research Protections (OHRP), 
the Department of Health and Human Services (DHHS) and similar agencies in other countries. 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00059454
Meeting Date Approved 7/12/2022          
Version Valid Until: 7/11/2023


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IRB Template Version 12/14/2018
Some of these people, agencies and businesses may further disclose your health information. If 
disclosed by them, your health information may no longer be covered by federal or state privacy 
regulations.  Your health information may be disclosed if required by law. Your health 
information may be used to create information that does not directly identify you. This 
information may be used by other researchers. You will not be directly identified in any 
publication or presentation that may result from this study unless there are photographs or 
recorded media which are identifiable.
Monitors, auditors, IRB or other regulatory agencies will be granted direct access to the 
participant’s original medical record for verification of clinical trial procedures or data, without 
violating confidentiality of the participant and to the extent permitted by other applicable laws.
If required by law or court order, we might also have to share your Protected Health Information 
with a judge, law enforcement officer, government agencies, or others. If your Protected Health 
Information is shared with any of these groups it may no longer be protected by federal or state 
privacy rules.
Any Protected Health Information collected from you in this study that is maintained in the 
research records will be kept for at least six years after the study is finished. At that time any 
research information not already in your medical record will either be destroyed or it will be de-
identified. Any research information entered into your medical record will be kept for as long as 
your medical record is kept by the Medical Center. You will not be able to obtain a copy of your 
Protected Health Information in the research records until all activities in the study are 
completely finished.
You can tell Drs. Catherine Matthews or Whitney Smith that you want to take away your 
permission to use and share your Protected Health Information at any time by sending a letter to 
this address:
Dr. Catherine Matthews and Whitney Smith
However, if you take away permission to use your Protected Health Information you will not be 
able to be in the study any longer. We will stop collecting any more information about you, but 
any information we have already collected can still be used for the purposes of the research 
study.
By signing this form you give us permission to use your Protected Health Information for this 
study.
If you choose to participate in this study, your medical record at Wake Forest University Baptist 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00059454
Meeting Date Approved 7/12/2022          
Version Valid Until: 7/11/2023


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IRB Template Version 12/14/2018
Medical Center will indicate that you are enrolled in a clinical trial.  Information about the 
research and any medications or devices you are being given as a participant may also be 
included in your medical record.  This part of the medical record will only be available to people 
who have authorized access to your medical record.  If you are not a patient at this Medical 
Center, a medical record will be created for you anyway to ensure that this important information 
is available to doctors in case of an emergency.
Laboratory test results and other medical reports created as a result of your participation in the 
research study may be entered into the computer systems of Wake Forest University Health 
Sciences and North Carolina Baptist Hospital.  These will be kept secure, with access to this 
information limited to individuals with proper authority, but who may not be directly involved 
with this research study.
A North Carolina Baptist Hospital (NCBH) medical record will be created for all study 
participants. Information about your participation in the study will be placed in the NCBH 
medical record, along with any routine medical test results that were obtained at NCBH as part 
of this study. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This website will not include information that can identify you. At most, the 
website will include a summary of the results. You can search this Web site at any time
WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or you may leave the 
study at any time. Refusing to participate or leaving the study will not result in any penalty or 
loss of benefits to which you are entitled. If you decide to stop participating in the study we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences. The investigators also have the right to stop your participation in the study 
at any time. This could be because it is in your best medical interest, your condition worsened, 
new information becomes available, you had an unexpected reaction, you failed to follow 
instructions, or because the entire study has been stopped. 
Information that identifies you may be removed from the data or specimens that are collected as 
part of this study and could be used for future research or shared with others without additional 
consent.
You will be given any new information we become aware of that would affect your willingness 
to continue to participate in the study.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or in the event of a research-related injury, contact the study 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00059454
Meeting Date Approved 7/12/2022          
Version Valid Until: 7/11/2023


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Adult Consent Form
IRB Template Version 12/14/2018
investigator, Whitney Smith, MD or Catherine Matthews, MD at 
(24 hours a day, 
7 days a week).
The Institutional Review Board (IRB) is a group of people who review the research to protect 
your rights. If you have a question about your rights as a research participant, or you would like 
to discuss problems or concerns, have questions or want to offer input, or you want to obtain 
additional information, you should contact the Chairman of the IRB at 
 or the 
Research Subject Advocate at 
.
You will be given a copy of this signed consent form.
SIGNATURES
I agree to take part in this study. I authorize the use and disclosure of my health information as 
described in this consent and authorization form.  If I have not already received a copy of the 
Privacy Notice, I may request one or one will be made available to me.  I have had a chance to 
ask questions about being in this study and have those questions answered.   By signing this 
consent and authorization form, I am not releasing or agreeing to release the investigator, the 
sponsor, the institution or its agents from liability for negligence.
Subject Name (Printed):_____________________________
Subject Signature: _________________________________ Date: ________Time:_______ am pm 
Person Obtaining Consent (Printed):_____________________________
Person Obtaining Consent:___________________________ Date:_________ Time:________ am pm
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00059454
Meeting Date Approved 7/12/2022          
Version Valid Until: 7/11/2023

Prot_000.pdf: 
Official Title:  A Randomized Clinical Trial of 100 Units of Intradetrusor 
Onabotulinum Toxin A for Refractory Overactive Bladder – Is 10 Injections less 
painful than 20 Injections? 
NCT04124939 
IRB-Approved Date:  4/25/22 
 


Wake Forest Baptist Health Department of Urology 
Protocol# IRB00059454  
Protocol version: 1 
Page 2 of 21 
Study Title: A Randomized Clinical Trial of 100 Units of Intradetrusor 
Onabotulinum Toxin A for Refractory Overactive Bladder – Is 10 Injections less 
painful than 20 Injections? 
Principal Investigator:  Catherine Matthews, MD 
 
Wake Forest Baptist Health, Winston Salem, NC 
  
Co-Investigators: 
Whitney Smith, MD 
 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
Gopal Badlani, MD 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
Robert Evans, MD 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
Majid Mirzazadeh, MD 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
 
Candace Parker-Autry, MD 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
Andre Plair, MD 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
 
Amr El Haraki, MD 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
 
Katherine Hines, MD 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
 
Anna Zdroik, DO 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
 
 
 
Sponsor or Funding Source: None at present.  
 


Wake Forest Baptist Health Department of Urology 
Protocol# IRB00059454  
Protocol version: 1 
Page 3 of 21 
Background, Rationale, and Context:  
Non-neurogenic Overactive bladder (OAB) is a chronic condition characterized by 
urinary urgency and frequency and can be associated with urinary incontinence.  It can 
be a particularly bothersome syndrome with a worldwide prevalence of approximately 
10.7% and is projected to be as high as 20.1% in 2018 [1]. The American Urological 
Association (AUA) and the Society of Urodynamics, Female Pelvic Medicine and 
Urogenital Reconstruction (SUFU) have established a combined set of guidelines for the 
treatment of OAB, amended in 2015, to help the clinician diagnose and treat patients in 
a tiered approach [2]. First line treatments are aimed at behavioral modifications (fluid 
management, bladder retraining, urge suppression techniques, pelvic floor muscle 
exercises, and physical therapy). Second line therapies are oral pharmacologics, and the 
two classes of medications are the antimuscarinics and a beta-3 agonist. Third line 
therapies, used to treat the patient with OAB that is refractory to first and second line 
therapies, include these three options: intradetrusor onabotulinumtoxinA (Botox®, 
Allergan, Inc.), sacral neuromodulation (SNM), and peripheral tibial nerve stimulation 
(PTNS). 
The United States Food and Drug Administration (FDA) has approved a dose of 
100 units of Botox® for refractory OAB based on rates of improvement of continence 
episodes while weighing adverse events [the most common being urinary tract infections 
(UTIs) and urinary retention requiring clean intermittent catheterization (CIC)]. However, 
what is not known is the optimal number of injections of the 100 units. The AUA/SUFU 
OAB guidelines do not recommend a specific number of injection sites. The European 
Association of Urology consensus report [3] recommends 10 Units/ml per injection (10 
one ml injections for 100 units). However, this was not based on randomized trials, and 
no studies have been done that directly compare different numbers of injection sites. The 
package insert for Botox® recommends 100 units combined with 10 cc of saline to be 
distributed in 20 injections (0.5 cc per injection) [4]. However, a literature search involving 
the methods of administration shows a range of 10 - 30 injections for 100 units of Botox® 
[3,5,11].  
One of the concerns about administering Botox® into the bladder is the patient’s 
comfort during the procedure as he or she is usually awake during this office based 
procedure. Patient experience is becoming a more important aspect of patient care, and 
is a marker for which provider are being measured. Currently, there are ongoing studies 
to assess whether or not 10 injections of Botox delivers the equivalent efficacy of 20 
injections of Botox in a national, multi-institutional trial. Uniquely, we would like to assess 
if there is a difference in the pain of procedure with 10 injections versus 20 injections.  
Our hypothesis is that Botox® distributed in 10 injections will result less pain of 
procedure perceived by the patient compared to the pain perceived by the patients 
receiving 20 injections. 
 
Objectives: 
● Primary endpoint: The primary endpoint to be assessed is the difference in pain 
of procedure experienced by those receiving 100 units of Botox ® in 10 injections 
versus those receiving 100 units of Botox in 20 injections. Our hypothesis is that 
those receiving 10 injections will perceive less pain. 


Wake Forest Baptist Health Department of Urology 
Protocol# IRB00059454  
Protocol version: 1 
Page 4 of 21 
○ Pain of procedure:  
■ Pain of procedure: To assess pain of procedure, we will use the 11 
point Numeric Pain Rating Scale (NPRS). We expect that the 
patients receiving 10 injections will have less pain associated with 
the procedure. The patients will rate their level of pain immediately 
following the completion of bladder injections by selecting a whole 
number from 0 to 10 that represents their level of pain (0 is no pain 
at all and 10 is the most severe pain) during the procedure. This 
scale has been validated, and correlates similarly to other pain 
scales [7]. 
● Secondary endpoints: Secondary endpoints to be assessed will be efficacy, OAB 
symptoms (nocturia, urgency, and frequency), post void residual volume (PVR) at 
2 weeks and 12 week post-procedure, disease specific bother, health related 
quality of life (HRQoL), the patient’s perceptions of change, and adverse events 
as detailed below: 
○ Efficacy: The reduction in mean urge incontinence episodes which will be 
calculated by averaging the amount of urge urinary incontinence episodes 
over 3 days as recorded in a bladder diary. Success will be defined as a 
greater than 50% reduction in urge incontinence episodes after 
intradetrusor Botox® based on 3-day bladder diaries collected at baseline 
and 12 weeks post-injection. This outcome measure is consistent with 
results reported in previous trials involving Botox® for overactive bladder 
[6].  
○ Disease specific bother and HRQoL: To assess OAB symptoms other than 
incontinence and impact on quality of life, we will administer the Overactive 
Bladder Questionnaire Short Form (OABq-SF) at baseline, at 2 weeks, and 
at 12 weeks post-procedure. This is an abbreviated version of the 
Overactive Bladder Questionnaire (OABq) developed to evaluate the bother 
and health related quality of life for patients with overactive bladder. The 
OAB-SF contains 6 items to assess symptom bother and 13 items to assess 
HRQOL. This questionnaire is commonly used, and has been validated for 
use in clinical practice [8]. 
○ PVR at 2 weeks and 12 weeks: To measure PVR at 2 weeks and 12 weeks, 
we will use a bladder scanner which measures volume based on ultrasound. 
The provider may also chose to measure PVR by straight catheterization at 
his or her discretion. 
○ Patient’s Global Impression of Change (PGIC) scale: In order to help 
determine the clinical significance of change, we will utilize the PGIC scale 
[16] administered at 2 weeks and 12 weeks post-injection. 


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○ Adverse events: Specific to intradetrusor injections of Botox®, the most 
common adverse events are urinary retention requiring intermittent 
catheterization (approximately 4%) [9] and urinary tract infections 
(approximately 15.5%-35%) [10]. Patients will be closely monitored for 
urinary tract infections as they will undergo urinanalysis and assessment of 
symptoms at their post-operative visits. 
Methods and Measures 
● Design:   
- 
This study is a randomized clinical trial to assess whether or not 10 
injections of 100 units of intradetrusor Botox® toxin is perceived as less 
painful compared to 20 injections of 100 units of intradetrusor Botox® toxin 
for the treatment of refractory OAB. Refractory OAB is defined as persistent 
urinary frequency and urgency despite behavioral modifications, failing a 
trial of 2 medications (anticholinergics or beta 3 agonists), have a 
contraindication to the medications, or are unable to tolerate medications 
due to allergies or side effects.  
- 
The primary outcome will be assessed by the patient completing the pain of 
procedure questionnaire, the NPRS, to be completed by the patient 
immediately after the procedure. The patient will receive the questionnaire 
from the nurse or medical assistant after the provider has performed the 
procedure. We will then compare mean value of the NPRS for the 10 
injection group to the 20 injection group. 
- 
Efficacy will be assessed by comparing study participant’s reduction in urge 
urinary incontinence episodes based on a 3 day voiding diary to be shared 
by the participant at baseline and 12 weeks post-procedure. This diary is 
dispensed to all patients during their visit prior to procedure visit as a part 
of standard of care. If subjects demonstrate a 50% reduction in urge 
incontinence episodes on a 3-day bladder diary, they will be categorized as 
“treatment success” whereas those who do not will be categorized as 
“treatment failure.” This dichotomous outcome will define efficacy as a 
secondary endpoint. 
- 
All eligible participants will be considered for the study. Patients will be 
counseled about the study in the office setting. Upon enrollment, patients 
will share a 3-day voiding diary. Diary is dispensed to all patients when they 
decide to undergo injection procedure. Disease specific bother and health 
related quality of life questionnaires will be completed following consenting. 
As per standard of care, urinalysis and post-void residual volume will be 
measurement. The only assessment in this list that is not part of standard 
clinical care are the questionnaires. If patients are on medications for 


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Page 6 of 21 
overactive bladder, they will be required to stop at least 3 weeks prior to 
undergoing the baseline 3 day voiding diary.  
After consenting to enrollment in the study, the patients will be scheduled for Botox® 
injections in the office. Randomization will be performed using random sequence number 
generation in blocks of 10 with randomization assignment concealed in sequentially 
numbered opaque envelopes. Randomization will be performed before the study startup 
by the coordinator using online available tool (sealed envelope). Envelopes with 50% 
carrying 10 injections instructions, and 50% carrying 20 injections instructions are 
prepared in advance, sealed, numbered 1 to 50, and stored in a locked cabinet at the 
Urology clinic at Charlois Blvd. Three envelopes will be carried to the Greensboro Wake 
Health System during coordinator’s scheduled clinic days. And then coordinator will bring 
those packets back to the Charlois Blvd Urology clinic on a regular base.  On the day of 
the procedure, the provider will select the next numbered envelope that will contain the 
randomization assignment for the number of injections. Subjects will be blinded to the 
randomization result. All patients will undergo a urinalysis prior to the procedure. If there 
is concern for an acute, untreated urinary tract infection, the patient does not undergo the 
procedure, and is treated with antibiotics while a urine culture is sent. All participants will 
be given preoperative antibiotics (except aminoglycosides). 100 units of Botox® will be 
combined with 20 cc saline for the purposes of 20 injections, or 100 units of Botox® will 
be combined with 10 cc of sterile saline for the purpose of 10 injections. Lidocaine Jelly 
locally. And the bladder will be instilled with 30ml of Marcaine and 5ml of NaHCo3 solution 
through a catheter for at least 15 minutes prior to the procedure. Cystoscopy with either 
a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile 
technique. The Botox® will be injected in a grid like pattern avoiding the trigone as seen 
below. Study patients do not know the number of injections received in the bladder. 
There are two providers in the room for each procedure. Injection counting will be 
verbalized as Injection 1, Injection 2… to up to Injection 20 by non-injecting provider. 
A patient and a provider who is injecting will hear total of 20 counts. Providers will 
know the randomization prior to procedure, and a decision will be cleared between 
two providers whether to account pseudo injection at odd or even number for patients 
receiving 10 injections. A patient randomized to 10 injections will receive 10 
injections at alternate count. All patients will be informed in advance about the 
procedure at the time of consenting.The patient will be allowed to void on her own post-
procedure. Immediately after the procedure, the patient will receive a questionnaire to 
rate the pain of procedure using the numeric pain scale. The patient will then be 
discharged to home.Figure 1: Diagram showing sites of injections for patients undergoing 
10 injections of 100 units of Botox®. 
 
 
 
 


Wake Forest Baptist Health Department of Urology 
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Protocol version: 1 
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Figure 1: Diagram showing sites of injections for patients undergoing 10 injections of 
100 units of Botox®. 
 
 
 
 
 
 
Figure 2: Diagram showing sites of injections for patients undergoing 20 injections of 
100 units of Botox® 
 
- 
At two weeks, the patient will return to clinic for a standard office visit. She 
will have a post void residual checked using either a bladder scan or 
catheter, and a urinalysis (urine culture will be sent per clinic protocol). If a 
urine culture grows any bacteria, and the patient is symptomatic, she will be 
treated with culture specific antibiotics. She will then be asked about 
symptoms of a urinary tract infection, if they have been treated for a urinary 
tract infection, difficulty emptying the bladder, or required intermittent or an 


Wake Forest Baptist Health Department of Urology 
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indwelling Foley catheter since the Botox® therapy. Subjects will complete 
the PGI-C and the OAB-SF. The patient will be sent home with a 3-day 
bladder diary to complete just prior to the 12-week visit. 
- 
At 12 weeks, the patient will return to clinic and her 3-day bladder diary will 
be reviewed. A post void residual volume will be checked using either a 
bladder scan or catheter, and a urinalysis will be sent per standard practice 
(urine culture will be sent per clinic protocol). If a urine culture grows any 
amount of bacteria and the patient is symptomatic, she will be treated with 
culture specific antibiotics. She will then be asked about symptoms of a 
urinary tract infection, if they have been treated for a urinary tract infection, 
difficulty emptying her bladder, or required intermittent or an indwelling 
Foley catheter since the Botox® therapy. She will again take the OABq-SF 
and PGIC. 
● Setting:  
- 
This study will take place at two Urology clinic locations at Wake Forest 
Baptist Medical Center, 140 Charlois Boulevard in Winston Salem, NC and 
3903 North Elm Street in Greensboro, NC. 
Subjects Selection Criteria 
● Inclusion criteria: Subjects must meet the following inclusion criteria in order to 
be eligible for the study 
1. Female gender 
2. At least 18 years of age 
3. Have already decided to undergo intradetrusor Botox® injections for 
treatment of refractory overactive bladder. 
4. Able and willing to learn clean intermittent catheterization (or care provider 
is willing and able to perform intermittent catheterization). 
5. Understands and is willing to undergo follow up and complete 
questionnaires as described in this protocol 
6. Able to give informed consent 
● Exclusion Criteria: 
1. Male gender 
2. Neurological conditions (Examples: Cerebral vascular accident within 6 
months prior to treatment, Parkinson's disease, Multiple Sclerosis, and 
Spina Bifida). 
3. Acute urinary tract infection  
4. Treatment with Botox® toxin for other conditions 
5. Allergy to Botox® toxin 
6. Hematuria that has not been worked up 
7. Known bladder malignancy 


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8. Previous history of bladder augmentation 
9. Currently pregnant (with no plans to become pregnant within 6 months of 
enrollment) or breastfeeding 
10. Currently taking aminoglycoside antibiotics 
11. PVR >150 cc (measured by bladder scan or by catheterization) prior to 
enrollment 
12. History of bladder pain syndrome. 
● Sample Size:  
• This study is unique as there are no previous trials assessing pain of 
procedure associated with intravesical administration of bladder Botox. To 
calculate sample size in the study, we will assume an effect of size of 1. We 
expect that patients receiving 20 injections will be within the moderate pain 
range (between 5 to 7 on the NPR scale). Therefor we will assume a mean 
NPR rating for patients receiving 20 injections would be 6 with a standard 
deviation of 2. Patients receiving 10 injections will be expected to have less 
pain and be in the mild pain range (from 1 to 4 on the NPR scale). Based 
on this, we would need 16 patients in each group. Accounting for a 20% 
drop out rate, we would need to accrue 20 patients in each group. 
● Statistical Analysis:  
1. Primary endpoint: Each patient will be asked to rate her pain level of 
procedure by completing the NPRS immediately after her procedure. The 
mean NPRS score of each group (10 injections vs 20 injections) will be 
calculated and compared using a paired T test.  
2.   Secondary endpoints 
▪ 
Each patient’s mean number of urge urinary incontinence episodes 
will be calculated by averaging the number of urge urinary 
incontinence episodes collected over 3 days as recorded on a 
bladder diary. This will be calculated pre-intervention at baseline and 
at 12 weeks. As previously described, “treatment success” is defined 
achieving greater than 50% reduction in the number of urge urinary 
incontinence episodes at 12 weeks after treatment with Botox®. A 
“treatment failure” will be defined as achieving less than 50% 
reduction in the number of urge urinary incontinence episodes at 12 
weeks after treatment with Botox®. Our hypothesis is that there will 
be more significantly “treatment responders” in patients receiving 20 
injections compared to 10 injections. To assess for clinical 
significance Chi square (Χ2) will be used. 


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▪ 
OABq-SF and PGIC collected from the group receiving 20 injections 
and the group receiving 10 injections. The mean will be calculated 
for each of the outcomes and for each of the groups. The result will 
be compared using paired t-test.  
▪ 
We will compare the mean number of patients with urinary retention 
and UTIs in patients in both groups (those receiving 20 injections and 
those receiving 10 injections). To test for significance we will use the 
t-test. 
Interventions and Interactions 
● This study will use the FDA approved dose for refractory overactive bladder which 
is 100 units of onabotulinum toxin A (Botox®). 
● Per surgeon preference, a flexible cystoscope or a rigid cystoscope will be used to 
inject the Botox® in the wall of the bladder.  
● Injections will be in a grid-like fashion. 
● We will use a 3 day bladder diary obtained from the International Urogynecological 
Association (IUGA) for baseline and 12 week follow up. (Appendix 1) 
● Immediately after the treatment, patients will be asked to rate their pain using the 
Numeric Pain Scale. Please see appendix. 
● Patients will be assessed for adverse events, symptom specific and global quality 
of life using the form in the appendix. 
● All surveys will be handed to the patients by nursing. Patients will fill out the forms 
before seeing a physician. 
Outcome Measures: Outcome measures to be assessed include: pain of procedure, 
urge urinary incontinence episodes, efficacy, bother, HRQoL, PGIC, urinary tract 
infection, urinary retention requiring catheterization. 
 


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Calendar of Events: 
Form/Intervention 
Baseline 
Day of 
Procedure 
(Botox 
Injections) 
2 weeks 
12 weeks 
ICF 
x 
 
 
 
PVR 
x 
 
x 
x 
Urinalysis 
x 
x 
x 
x 
Study Inclusion 
Form 
x 
 
 
 
Bladder Diary 
x 
* 
 
x 
Randomization 
 
x 
 
 
Pain Scale 
 
x 
 
 
OABq-SF 
x 
 
x 
x 
PGIC 
 
 
x 
x 
Adverse Events 
Questionnare 
 
 
x 
x 
Completion of 
Study Form 
 
 
 
x 
*: Collect the completed Diary 
 
Human Subjections Projection 
Subject Recruitment Methods:  Patients evaluated in the office setting and who are 
diagnosed with refractory overactive bladder will be counseled regarding their options for 
treatment. The 3 treatment options include: intradetrusor injection of onabotulinum toxin, 
sacral neuromodulation, and percutaneous tibial nerve stimulation. After weighing the 
risks and benefits of all procedures, patients opting for therapy with onabotulinum toxin A 
will be considered for the trial. A member of the study team will discuss eligibility, review 
the inclusion/exclusion criteria, and answer questions. Informed consent will be signed. 
Three day diary provided during the at visit as per Standard of Care will be reviewed 
belonging all participants in order to capture the information. Any patient who wishes to 
withdraw from the study may do so at any time. If the patient chooses to withdraw, they 
will be presented with the option to allow the data collected up to that point to be retained, 
or have it removed. 


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All data will be kept on a secure password protected and encrypted hospital issued 
computers and contained within password protected files. Source documents will be kept 
in a locked drawer on Wake Forest Baptist Health property. 
Informed Consent: Signed informed consent will be obtained from each subject. The 
principal investigator and co-investigators will obtain informed consent. The informed 
consent process will take place in the Urology offices in either Winston-Salem, NC or 
Greensboro, NC. 
Confidentiality and Privacy: Confidentiality will be protected by collecting only the 
information needed to assess study outcomes, minimizing the collection of any 
information to the fullest extent possible that could directly identify subjects, and 
maintaining all study information in a secure manner. To help ensure subject privacy and 
confidentiality, only a unique study identifier will appear on the data collection form. Any 
collected patient identifying information corresponding to the unique study identifier will 
be maintained on a linkage file, stored separately from the data. The linkage file will be 
kept secure, with access limited to designated study personnel. Following data collection, 
subject identifying information will be destroyed 3 years after closure of the study by 
shredding, consistent with data validation and study design, producing an anonymous 
analytical data set. Data access will be limited to study staff. Data and records will be kept 
locked and secured, with any computer data password protected. No reference to any 
individual participant will appear in reports, presentations, or publications that may arise 
from the study. 
Data and Safety Monitoring: The principal investigator will be responsible for the overall 
monitoring of the data and safety of study participants. The principal investigator will be 
assisted by other members of the study staff. 
Reporting of Unanticipated Problems, Adverse Events or Deviations: Any 
unanticipated issues, serious and unexpected adverse events, deviations or protocol 
changes will be promptly reported to the principal investigator or member of the research 
team, the IRB, sponsor, and appropriate government agency if appropriate. 


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Appendix 1: IUGA 3 day Bladder Diary Sample 
 


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Appendix 1: IUGA 3 Day Bladder Diary to be completed by the patient. 
 


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Appendix 2: Pain assessment to be completed immediately after the procedure 


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Medical Record Number: ____________________ 
 
 
 
Date: ____________________________________ 
 
 
 
 
 
 
1 Since your last visit, have you been diagnosed with a UTI? 
Yes 
No 
2 Do you have any of the following symptoms? 
 
 
3 - Burning with urination 
Yes 
No 
4 - Blood in the urine 
Yes 
No 
5 - Fever 
Yes 
No 
6 
Since your last visit, have you been evaluated in the 
emergency room? 
Yes 
No 
7 
Since your last visit, have you been evaluated by your 
primary doctor? 
Yes 
No 
8 
Since your last visit, have you required a urinary catheter, 
(intermittent or indwelling)? 
Yes 
No 
9 
Since your last visit, have you seen blood in your urine that 
lasted more than 48 hr.? 
Yes 
No 
10 Since your last visit, have you had difficulty swallowing? 
Yes 
No 
11 Since your last visit, have you had difficulty breathing? 
Yes 
No 
 
Appendix 3: Follow up Adverse Event questionnaire to be completed at  2 weeks and12 
weeks 
 


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Appendix 4: OAB Short Form for Bother to be completed at baseline, 2 weeks and 12 
weeks. 
 


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Appendix 5: OAB Short Form for Bother to be completed at baseline, 2 weeks and 12 
weeks. 


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Appendix 6: PGI scale to be completed by patients at week 2 and week 12. 
References: 


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1. Worldwide Prevalence estimates of lower urinary tract symptoms, overactive 
bladder, urinary incontinence and bladder outlet obstruction. 
2. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: 
AUA/SUFU Guideline Amendment. 
3. Apostolidis, Apostolos & Dasgupta, Prokar & Denys, Pierre & Elneil, Sohier & 
Fowler, C-J & Giannantoni, Antonella & Karsenty, Gilles & Schulte-Baukloh, 
Heinrich 
& 
Schurch, 
Brigitte 
& 
Wyndaele, 
Jean-Jacques. 
(2008). 
Recommendations on the Use of Botulinum Toxin in the Treatment of Lower 
Urinary Tract Disorders and Pelvic Floor Dysfunctions: A European Consensus 
Report. European urology. 55. 100-19. 10.1016/j.eururo.2008.09.009. 
4. Botox®  Label. https://www.allergan.com/assets/pdf/Botox® pi.pdf. 
5. Kuschel, S., Werner, M., Schmid, D.M. et al. Int Urogynecol J (2008) 19: 905. 
https://doi.org/10.1007/s00192-007-0548-9 
6. Amundsen CL, Richter HE, Menefee S, et al. The Refractory Overactive Bladder: 
Sacral Neuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial. 
Contemp Clin Trials. 2014;37(2):272-83. 
7. Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a 
comparison of six methods. Pain. 1986;27:117–126. 
8. Coyne, K. S., Thompson, C. L., Lai, J. and Sexton, C. C. (2015), An overactive 
bladder symptom and health‐related quality of life short‐form: Validation of the 
OAB‐q SF. Neurourol. Urodynam., 34: 255-263. doi:10.1002/nau.22559. 
9. Nitti VW, Ginsberg D, Sievert KD, Sussman D, Radomski S, Sand P, et al. Durable 
efficacy and safety of long-term OnabotulinumtoxinA treatment in patients with 
overactive bladder syndrome: final results of a 3.5 year study. J Urol. 2016. 
10. Nitti VW, Dmochowski R, Herschorn S, et al. OnabotulinumtoxinA for the treatment 
of patients with overactive bladder and urinary incontinence: results of a phase 3, 
randomized, Placebo Controlled Trial. J Urol. 2017;197:S216–23. 
11. Christopher P. Smith and Michael B. Chancellor.Journal of Endourology.Simplified 
Bladder Botulinum-Toxin Delivery Technique Using Flexible Cystoscope and 10 
Sites of Injection. Sep 2005. http://doi.org/10.1089/end.2005.19.880 
12. The safety and efficacy of botulinum toxin-A in the management of bladder 
oversensitivity: a randomised double-blind placebo-controlled trial 
13. Syed, K., Gomez, C. and Gousse, A. (2017) Very Low, Real-Time Rate of Urinary 
Retention after Intradetrusor Botox® for Non-Neurogenic Overactive Bladder. 
Open 
Journal 
of 
Obstetrics 
and 
Gynecology, 
7, 
915-921. 
doi: 
10.4236/ojog.2017.78092. 
14. Leu, R. & Stearns, G.L.Complications of Botox® and their Management. Curr Urol 
Rep (2018) 19: 90. https://doi-org.go.libproxy.wakehealth.edu/10.1007/s11934-
018-0844-6 
15. Effects of botulinum toxin B on refractory detrusor overactivity: a randomized, 
double-blind, placebo controlled, crossover trial. 
16. Hurst, Hugh et al. Assessing the clinical significance of change scores recorded 
on subjective outcome measures. Journal of Manipulative & Physiological 
Therapeutics, Volume 27, Issue 1, 26 - 35. 


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SAP_001.pdf: 
Official Title:A Randomized Clinical Trial of 100 Units of Intradetrusor Onabotulinum Toxin A for Refractory 
Overactive Bladder - Is 10 Injections Less Painful Than 20 Injections?  
NCT04124939
Date: 7/31/23


Statistical Analysis – 10 vs 20 Botox Injections 
 
Standard descriptive statistics were used to compare demographic and clinical 
characteristics. Frequency and percentages were reported for categorical 
data. Chi-square and fisher exact test for categorical variables and student t-
test or Mann-Whitney U test for continuous variables were used to assess 
significant differences between the groups. Statistical analysis was performed 
on R Software.