Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction
Phase: NA
Conditions: Neurogenic Bladder, Lower Urinary Tract Symptoms, Overactive Bladder, Neuro: Neurogenic Bladder, Neurogenic Detrusor Overactivity
Sponsor: The Methodist Hospital Research Institute

 
 
 
 
 
 
Optimization of OnabotulinumtoxinA (BTX-A) Injection for the 
Treatment of Neurogenic Lower Urinary Tract Dysfunction 
 
 
 
 
NCT06059066 
 
 
 
 
Last Approved: September 10, 2024 

1
PROTOCOL TITLE:
Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower 
Urinary Tract Dysfunction
PRINCIPAL INVESTIGATOR
Rose Khavari, MD
CO-INVESTIGATORS/ COLLABORATORS:
-Annie Chen, MD - Fellow
-Ricardo Gonzalez, MD - Department of Urology
-Kathleen Kobashi, MD – Department Chair, Department of Urology
-Julie Stewart, MD- Department of Urology
-Hamida Rajab – Research Coordinator, Department of Urology
-Betsy Salazar - Research Coordinator, Department of Urology
-Julu Benoy – Clinical Research Specialist, Department of 
Urology
SPONSOR / FUNDING AGENCY
NIH Office of the Director (Prime Sponsor), CAIRIBU (Direct Sponsor)
VERSION NUMBER/DATE
Version 2.1/ 10/26/2023
REVISION HISTORY
Not Applicable
Revision #
Version 
Date
Summary of Changes
Conse nt 
Chang e 
(Yes/N o)
1
8/17/2023
Initial Protocol
2
10/09/2023
There is only one follow up visit that will take place 
4 to 6 weeks post Botox procedure; Dr. Julie Stewart 
has been added as a sub- I to the study
Yes
2.1
10/26/2023
Expanded indications to include all indications for 
injection of 200 or 300 units of Botox except painful 
bladder conditions such as interstitial cystitis (IC) or 
chronic pelvic pain (CPP)
Yes
2.2
11/30/20203
Adding a 6-12 months retrospective review to stay 
consistent with our specific aim
Yes
1.
Study Summary
Urinary urgency, frequency, and urgency incontinence without urinary tract infection are 
components of a syndrome called overactive bladder (OAB). OAB affects up to 27% of 
women in the United States and has been shown to negatively impact quality of life and 
increase rates of depression and sleep disturbances.1-4 For patients who are
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inadequately managed with medications and conservative, third-line therapies are 
offered which include OnabotulinumtoxinA (BTX-A) or Botox injections.
BTX-A is a highly efficacious therapy with a reliable safety profile and demonstrable 
improvements in subjective and objective measures for OAB symptom control.4-7 This 
procedure is quick and requires minimal equipment, making it ideal for the outpatient 
office setting. Despite BTX-A being a common practice, limited research has been done 
to optimize the injection technique for 200 or 300 units of BTX-A. This amount of BTX-A 
can be administered to patients who suffer from non-idiopathic OAB caused by 
conditions which include but are not limited to a neurological disorder, refractory 
idiopathic OAB8, and radiation cystitis9.
Neurological disorders such as Multiple Sclerosis (MS), Spinal Cord Injury (SCI), 
Parkinson’s Disease (PD), Spina Bifida (SB), and stroke disrupt neural control of 
voiding and lead to the development of neurogenic lower urinary tract dysfunction 
(NLUTD), which develops when either the detrusor muscle fails to maintain effective 
contractions (voiding phase) or fails to relax appropriately with low pressures (storage 
phase), if the urethral sphincter (internal or external) fails to lower its tonicity and 
resistance, or if there is an asynchrony in events eventually leading to detrusor 
sphincter dyssynergia (DSD). Different patterns of NLUTD (including both storage and 
voiding) can arise depending on the level of injury or type of neurological disease. It 
can be characterized by urinary urgency, frequency and incontinence or urinary 
hesitancy and retention that leads to urinary tract infections (UTIs).
Management of NLUTD symptoms is complex. Treatment with BTX-A has been 
shown to decrease episodes of urinary incontinence and improve quality of life in this 
population. It has also been shown to ameliorate a multitude of devastating 
complications, such as upper tract deterioration, recurrent urinary tract infections, 
sepsis, and death.10-11 According to the current manufacturer’s recommendation, a 
standard 200-unit vial of Botox® should be diluted in 30cc of 0.9% saline and injected 
across 30 different sites in the detrusor muscle. Despite these guidelines, there are 
wide variations in administration techniques, raising the question of what the best 
depth and location for injection, optimal concentration, and volume of toxin per 
injection site is. The objective of this study is to determine the optimal injection schema 
for 200 or 300 units of intradetrusor BTX-A in the office setting.
We hypothesize that patients indicated for an injection of 200 or 300 units of BTX-A 
for all indications will be more willing to pursue additional sessions of BTX-A 
injections with a protocol utilizing less injection sites, while still maintaining 
effectiveness of the procedure.
2.
Purpose of the Study / Objectives
Specific Aim 1: To evaluate patient satisfaction and perceived discomfort during office- 
based injection of intradetrusor BTX-A via two different administration protocols.
a. We will assess and compare validated questionnaires between two groups of 
patients receiving 20 versus 5 injections. We will assess and compare patient 
willingness to continue with treatment by the number of repeated sessions of BTX-A 
injections over 12 months of follow-up.
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Specific Aim 2: To evaluate treatment effectiveness between the two different 
administration protocols.
a. We will compare validated questionnaires between two groups of patients receiving 
20 versus 5 injections.
b. We will compare procedure time between the two groups.
We will compare two common and specific adverse events (AEs) between the two groups 
including symptomatic UTIs, symptomatic gross hematuria, and new-onset incomplete bladder 
emptying necessitating de-novo bladder catheterization.
3.
Background
Proper function of the lower urinary tract (LUT) is intricately regulated by the central 
nervous system. To achieve both storage and release of urine (voiding) the connections 
between the brain, spinal cord and peripheral innervations connected to the LUT must 
be intact12. During bladder filling, sympathetic nuclei at the T11-T12 spinal level 
mediate contraction of the urethral sphincter and relaxation of bladder wall through the 
hypogastric and pudendal nerves. Once it is deemed appropriate to void, tonic inhibition 
of the pontine micturition center (PMC) by cortical and subcortical centers is 
reversed.20 Parasympathetic nuclei at the S2-S4 spinal level extend their axons to 
pelvic ganglia via sacral roots and pelvic nerves to ganglia in the pelvic plexus and the 
bladder wall. Acetylcholine and noradrenaline released from postganglionic nerve 
terminals onto M3 muscarinic receptors induce bladder contraction, while simultaneous 
acetylcholine release from somatic axons relaxes urethral smooth muscles, all leading 
to effective bladder emptying.
Neurological disorders such as Multiple Sclerosis (MS), Spinal Cord Injury (SCI), 
Parkinson’s Disease (PD), Spina Bifida (SB), and stroke disrupt neural control of 
voiding and lead to the development of neurogenic lower urinary tract dysfunction 
(LUTD), which develops when either the detrusor muscle fails to maintain effective 
contractions (voiding phase) or fails to relax appropriately with low pressures (storage 
phase), if the urethral sphincter (internal or external) fails to lower its tonicity and 
resistance, or if there is an asynchrony in events eventually leading to detrusor 
sphincter dyssynergia (DSD).
Different patterns of NLUTD (including both storage and voiding) can arise 
depending on the level of injury or type of neurological disease. It can be characterized 
by an overactive bladder (OAB) symptom complex which may include urinary urgency, 
frequency and incontinence or urinary hesitancy, and also retention that may lead to 
urinary tract infections (UTIs). Conditions such as radiation cystitis or BCG induced 
cystitis may also cause disruption of the neural control of voiding leading to lower 
urinary tract dysfunction and OAB9.
Management of LUTD symptoms primarily due to storage dysfunction include 
various pharmacological agents (anticholinergics, antimuscarinics, beta-3- receptor 
agonists), intradetrusor injection of onabotulinumtoxinA (BTX-A) and tibial or sacral 
neuromodulation modalities. Despite the availability of different techniques to 
manage bladder function that have shown some improvement, it is important to 
continue to improve these treatment modalities to better serve individuals with LUTD 
due to storage dysfunction. The objective of this study is to determine the optimal 
injection schema for 200 or 300 units of intradetrusor BTX-A for all patients in the
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office setting.
4.
Study Design
This will be a single-blinded, parallel randomized control. Patients will be randomized into one of 
two groups:
-Schema 1: 200 or 300 units BTX-A reconstituted in 20 mL normal saline, injected into 
the bladder detrusor in 20 separate injections of 1 mL including the trigone.
-Schema 2: 200 or 300 units or more BTX-A reconstituted in 5 mL normal saline, 
injected into the bladder detrusor in 5 separate injections of 1 mL including the trigone
This trial will be designed and reported as outlined in the CONSORT guidelines.
Endpoints:
Primary Endpoints:
a. Change in patient willingness to repeat BTX-A injection procedure as assessed with 
an 11-point visual analog scale.
b. Change in discomfort in patients that undergo BTX-A injection, measured using the 
Numeric Pain Scale scores provided by patient prior to and following the treatment 
procedure.
c. Change in Patient Global Impression of Improvement score provided 6 weeks post- 
procedure.
Secondary endpoints:
a. Change in procedure times (from cystoscope insertion to removal).
b. Change in International Consultation on Incontinence Questionnaire-Urinary 
Incontinence Short Form.
c. Change in Neurogenic Bladder Symptom Score – Short Form
Safety endpoints:
a. Incidence of symptomatic UTI within the first 4- 6 weeks after the procedure.
b. Incidence of bleeding requiring admission or hospital/office evaluation related to the 
injection procedure.
c. Rate of bothersome incomplete bladder emptying requiring de novo 
catheterization within the first 4-6 weeks.
Demographic data: collected from the EMR for secondary analysis
•
Age
•
Gender/sex
•
Race
•
Body mass index (BMI)
•
Diagnoses at the time of procedure – nature of neurogenic bladder
•
Is the patient naive to BTX-A or not
•
Number of total BTX-A procedures
•
Past medical history
•
Past surgical history
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•
Chronic narcotic use
•
3 or more symptomatic UTI in the last year
•
Current Anticoagulation use
•
Other GU relevant medications
•
Mode of bladder emptying? Spontaneous voiding, CIC, Foley, SPT
•
History of bladder augmentation?
•
History of bladder outlet procedures
•
Was anticoagulation stopped for the procedure?
Sample size and power calculation: Sample size was calculated by powering the 
primary outcome (11-point visual analog scale for willingness to repeat the procedure, 
Range: 0-10) between the two study arms. A continuous model was utilized. Cohen 
effect sizes were used with a power of 80% with statistical significance defined as an 
alpha of 0.05 for a target sample size of 74 patients. Accounting for a 5% drop out rate, 
our final target sample size will be 78 patients split between the two study groups 
(please see the randomization plan below).
Recruitment: Individuals with the diagnosis of OAB symptoms (frequency, urgency, UUI) 
who do not have a painful bladder condition and scheduled to undergo 200 or 300 units 
of intradetrusor BTX-A will be identified through the electronic medical record (EMR).
The dosing amount will be determined by the physician who is indicating the patient for 
the BTX-A treatment based on clinical picture and is not influenced in any way by this 
study. We will recruit and sample from patients who are already scheduled for this 
therapy prior to study enrollment. Patients who meet inclusion criteria will be 
approached on the day of the procedure and consented in person if they are interested 
in participating.
5.
Study Intervention
The study will include a clinic visit for the Botox procedure, a scheduled follow-up visit, 
and possibly a 15-minute phone call approximately 6 weeks after Botox injection.
During the clinic visit, the patient will rate the patient’s willingness to repeat the procedure 
and pain level and fill out a short questionnaire called the International Consultation on 
Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and Neurogenic 
Bladder Symptom Score-Short Form (NBSS-SF). At the follow-up visit, the patient will fill out 
the ICIQ-UI SF and NBSS-SF again to assess symptom improvement, Patient Global 
Impression (PGI) of Improvement score, and assess the patient’s willingness to repeat the 
procedure. The questionnaire should take roughly 5 minutes to fill out. The component of the 
patient’s participation that is being researched is the patient’s willingness to repeat the 
procedure, response to questionnaires, and clinical response to the Botox. In addition, if the 
patient participates in the study, data from the medical record will be collected for this 
research. Types of data collected include demographic and baseline characteristics, 
procedural time, procedural response, discomfort with the procedure, and any procedural 
complications encountered. Besides 4-6 weeks follow-up, patients charts will retrospectively 
reviewed at the 6-12 months At 6 months to 1 year after their Botox injection, to see if 
additional therapies were pursued. 
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Intervention
Procedure 
visit
Post- 
procedure 
visit (4-6 
weeks after 
procedure 
visit)
12 months after 
procedure visit
Sign consent form
X
ICIQ-UI SF Questionnaire
X
X
NBSS-SF
X
X
PGI score
X
Numeric Pain Rating Scale
X
Willingness to 
repeat procedure 
scale
X
X
Randomization
X
Chart review for whether 
patients continued Botox 
or underwent alternate 
therapies to Botox
x
6.
Drugs, Biologics, Devices
a.
Onabotuliumtoxin A (BTX-A) injections into the bladder will be evaluated in this 
research.
b.
BTX-A is a commonly used therapeutic entity for the treatment of OAB and is FDA 
approved for this indication13.
c.
We will only be studying patients who are already scheduled to undergo BTX-A 
injections for a dosage of 200-300 units.
d.
This therapy is typically well tolerated with high patient satisfaction ratings for the 
treatment of OAB. The risks related to this therapy are described in the following 
sections.
7.
Collaborative / Multi-site Research
This will be a single-site study within the Houston Methodist System in the departments 
of Urology.
8.
Data Privacy / Confidentiality
• Protected Health Information (PHI) will be collected for this study through the electronic 
medical record
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• Houston Methodist policies for PHI will be followed, including all requirements for all 
physical and electronic data security. Encrypted devices will be used, and all information 
will be stored on HM password protected servers.
• All research team members will be CITI trained and registered through the HMRI. Only 
authorized study members will have access to physical (consents, OABs-QF forms) and 
electronic study data/PHI.
• Data will be primarily stored within the RedCap data management system through HM. 
Data will only be input on password protected computers through the Houston Methodist 
system and no data will be stored on desktops or in shared drives.
• Data will not be transmitted via email or other non-encrypted forms of communication.
• Physical forms (consents and questionnaires) will not be transported to personal 
residence and will be stored confidentially as listed above only in a Houston Methodist 
Building.
• We will collect only the minimum amount of PHI necessary, and this will not be 
disclosed beyond Houston Methodist.
• PHI stored within RedCap will be de-identified. Patients will be assigned a study 
number that will be included with their consent form. These files will be kept within a 
locked file cabinet within a locked office in Houston Methodist Smith Tower, only the PI 
and primary members of the research team will have access to these files. No photos or 
videos will be collected. The subjects will be de-identified immediately after recruitment.
• Per HMRI policy, the consents and physical/electronic study data that is collected will be 
kept for a minimum of 6 years. Physical files will be kept in a locked cabinet within the 
study coordinators locked office at Houston Methodist. The data collection timeframe is 4 
to 6 weeks and there are no plans for long term outcome data. Therefore, the data 
collected on physical forms will be confidentially shredded via the HM policy for disposal 
of PIH and discarded in PIH protected bins. The data stored through RedCap will be 
deleted.
• Accountable, complete, original, accurate, and legible records for the life of the study 
and required maintenance will be assured through the minimalization of research team 
members participating in recruitment and data collection. All team members will be 
permanent, contracted Houston Methodist employees that are research certified. Legible 
recording will be assured through the use of black/blue permanent ink on written forms in 
non-cursive text.
Identifier (or parts of)
Recorde 
d
Disclose 
d
Comment
Names
Yes
No
All elements of dates (except year) for 
dates directly related to an individual, 
including birth date, admission date, 
discharge date, date of death; and all 
ages over 89 and elements of dates 
(including year) indicative of such age
Yes
Yes
If required by the IRB 
and FDA to verify the 
data authenticity
Medical record numbers
Ye
s
N
o
Phone numbers, fax numbers
Ye
s
N
o
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Email address
Ye
s
N
o
9.
Data and Specimen Banking
As listed above.
10.
Study Population
Inclusion
• Adult men and women (>18 years of age) with any diagnosis indicated for the injection 
of 200 or 300 units of BTX-A including radiation cystitis, or due to neurologic bladder 
secondary to neurological conditions such as MS, PD, CVA, myelomeningocele, SCI, 
or traumatic brain injury longer than 6 months prior to treatment.
• Participants must be able to provide informed consent, as well as understand and be 
willing to undergo follow-up procedures and completion of all questionnaires provided during 
the study.
Exclusion
• Symptomatic UTI at the time of procedure, defined as positive nitrites orhigh-volume 
leukocyte esterase on urine dip in addition to at least one of the following symptoms: 
dysuria, gross hematuria, suprapubic pain, frequency/urgency above baseline.
• Diagnosis of bladder pain syndrome or other chronic pain syndrome including 
fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levatormyalgia.
• Untreated bladder malignancy.
• Women who are currently pregnant or breast feeding.
• Contraindications to intradetrusor BTX-A injections.
11.
Screening and Recruitment S R
All patients scheduled to undergo injection of 200 or 300 units of intradetrusor BTX- 
A for all indications other than bladder pain syndrome will be identified through the 
electronic medical record (EMR). A trained, primary member of the research team will 
identify all patients scheduled for BTX-A as listed on the EPIC schedule for the Urology 
providers listed above: Dr. Ricardo Gonzalez, Dr. Julie Stewart, Dr. Rose Khavari, and 
Dr. Kathleen Kobashi. Without opening charts, a note can be placed on the schedule for 
patients >18 yo to be evaluated for study qualification. The physician caring for the 
patient on the day of their scheduled BTX-A procedure will identify whether the patient 
meets inclusion/exclusion criteria for study enrollment based on the criteria listed in this 
protocol (inclusion and exclusion criteria are listed in the Study Population section 
above). By this process, the patients’ information in the EMR will only be accessed by 
primary medical team members and will only be accessed by study team members after 
patients agree to enroll.
These patients will be approached on the day of the procedure and consented to in 
person if they are interested in participating. Other than a detailed consent form, no 
recruitment materials or advertisements will be utilized as part of this study.
12.
Withdrawal of Subjects
Subjects would be withdrawn from the study if they are found to have symptomatic
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urinary tract infection on the day of the procedure – this would be defined by symptoms 
such as dysuria, frequency or urgency above baseline, or hematuria along with a urine 
dip that is positive for nitrites or leukocyte esterase.
• Subjects would be withdrawn if they are not able to tolerate the procedure itself and it 
is terminated prior to full injection of reconstituted BTX-A or if BTX-A was not able to be 
injected for other reasons (difficult anatomy, unable to pass scope or perform in the 
office)
13.
Provisions to Protect the Privacy Interests of Subjects
Privacy will be protected by ensuring that the patient interacts with and discloses 
information to only essential members of the research team to maximize confidentiality. 
Caregivers that patients interact with during a typical BTX-A procedure include front 
desk staff for check in, the nurse/medical assistant helping with the procedure, a 
resident or fellow if present in clinic that day, and the attending staff. Additional 
personnel patients would have to interact with to participate in the study would be a 
research member during the consent process (Dr. Betsy Salazar, Hamida Rijab, Julu 
Benoy, research coordinators) and a research member during the telephone follow-up. 
The patient will be made to feel at ease with this research through a thorough 
explanation of the study protocol, the BTX-A procedure itself, and follow-up telephone 
encounters. All study members will be introduced by name and title and it will be well- 
explained that either injection protocol are standard ways that we perform BTX-A in the 
office every day.
14.
Risks to Subjects
The risks to the subjects participating in this study are only represent risks inherent to 
the nature of the BTX-A procedure itself – risks all subjects would be incurring 
regardless or participation or exemption given that we are only including patients who 
are scheduled for BTX-A prior to enrollment.
Risks of undergoing intradetrusor BTX-A include: Post-procedural UTI (up to 10-30% in 
the literature, variations based on definition of UTI), bleeding requiring admission (<1%), 
and urinary retention (up to 5%).
There is some risk of physical discomfort with injections, which we are hopeful to 
optimize with the results of this data. We ameliorate this risk through the instillation of 
local anesthetic into the bladder, which is standard protocol for all BTX-A injections and 
is recommended on the package insert/FDA approval for BTX-A.
There should be no psychological, social, legal, or economic risks to the subjects. 
There is a small risk of loss of confidentiality that is inherent to the nature of any study 
participation. We will work to minimize this risk through the early de-identification of 
participants and through careful data storage by protected platforms as described 
above.
BTX-A is considered to be pregnancy category C according to the package insert. This 
is based on animal studies, showing mostly reduction in fetal birth weight, as very 
limited studies regarding BTX-A in pregnancy have been performed in humans. A 
survey study of physicians who have performed BTX-A in pregnant women, knowingly 
or unknowingly, shows minimal risk14. For this research, the majority of our patients are 
post-menopausal. We do not perform BTX-A injections in women with known
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pregnancies. Pregnancy is an exclusion criterion for this study – all women of 
reproductive women will be screened for pregnancy.
There are no risks to patients who do not participate as study subjects.
15.
Potential Benefits
1.
Every patient in the study will benefit from intradetrusor BTX-A injections, ahighly 
effective treatment, as prescribed by their physician for their condition.
2.
A potential benefit to the individual could be reduced procedural discomfort due to an 
optimized injection protocol.
16.
Financial and Economic Issues
-There is no cost to the patients associated with participation in this study.
-Patients will be compensated $100 for their participation in this study. They will receive
$100 at the initial visit and another $50 after completion of the second round of surveys 
at their scheduled follow-up visit. If they miss the opportunity to fill out the survey at the 
follow-up visit, they will be contacted by phone.
17.
Data Safety Plan
Standard methods to protect privacy will be maintained. The identities of study subjects 
will remain confidential. Only the PI, primary co-investigator, and study coordinator will 
have access to the names of the participants. All consent forms and randomization 
allocations will be stored in a locked cabinet in the study coordinator’s password- 
protected HMH office. Any electronic data will be securely stored in the primary co- 
investigator’s (Miceli) office on a password protected office computer. This office is 
always locked, and the computer is only opened through password protection. All data 
will be stored in Houston Methodist’s electronic record keeping system RedCap for 
organization and analyses. All physical data/consents will be destroyed (shredded or 
erased from the computer hard drive) when use is no longer needed but not before a 
minimum of 3 years of data collection.
18.
Informed Consent Documentation and Process
Informed consent will be obtained from a member of the research team on the day of 
the BTX-A procedure. Patients undergoing intradetrusor BTX-A within the Urology 
offices at HMH TMC, West, Willowbrook, or Sugarland, will be identified the week prior 
and all subjects meeting criteria for inclusion will be approached about participation on 
the day of their scheduled procedure. If the subject fulfills inclusion criteria, the study 
team member (attending, fellow, research coordinator) will discuss the goal of the study 
and the process of BTX-A reconstitution and injection. If the patient is interested, the 
study requirements will be explained in detail - including requirements on the day of the 
procedure (short questionnaire, NPS rating prior to and after procedure) and 4 weeks 
follow up telephone call. The patient will be given appropriate time to answer any 
questions she may have related to the study. Written information will be provided, and 
the physician will allow adequate time for the subject to reflect flowing this discussion.
□If the patient agrees to participate, they will be consented in person by a member of 
the research team and will then be randomized. These documents will be safely stored
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as discussed above.
□A copy of the consent will be retained by the research coordinator in a locked file 
cabinet, and one copy will be given to the patient.
19.
Waiver of Informed Consent and /or Authorization
We will be requesting HIPAA waiver for performing preparatory research activities such 
as reviewing patient’s surgical and medical history and for the purpose of this study.
The researchers have taken steps to minimize this risk. The research team will take 
proper precautions to ensure that any information regarding a patient’s personal identity 
obtained in connection with this research will remain confidential. Patients will be 
assigned a unique study identification number. This number will be used to identify 
patients’s study participation; their personally identifiable data will be stored
separately. All study data will be stored in the secure and access-restricted REDCap 
research database maintained at Houston Methodist. Only the investigators and 
authorized study team members have access to the REDCap database. There are no 
plans to share any study data collected for this research with anyone outside of the 
study team; however, no one outside of the authorized study team would be able to link 
patients’s study code with their personally identifiable information. Any inclusion of 
patient identifiers within the database will not be shared externally outside of the study 
team.
20.
References
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Schaer G. An international urogynecological association (IUGA), International Continence Society 
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Journal 2010; 21: 5-26.
2. Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. 
Prevalence and burden of overactive bladder in the United States. World Journal of Urology. 2003; 
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Weber AM, John W. Refractory idiopathic urge urinary incontinence and botulinum A injection. Journal 
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6. Visco A, Brubaker L, Richter H, Nygaard I, Paraiso MFR, Menefee SA, Spino C, Nolen T, Wallace D, 
Meikle SF. Anticholinergic therapy vs OnabotulinumtoxinA for urgency urinary incontinence. New 
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7. Amundsen CL, Richter HE, Menefee S, Vasavada S, Rahn D, Kenton K, Harvie H, Wallace D, Meikle
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8. Abdelwahab O, Sherif H, Soliman T, Elbarky I, Eshazly A. Efficacy of botulinum toxin type A 100 Units 
versus 200 units for treatment of refractory idiopathic overactive bladder. Int Braz J Urol. 2015 Nov- 
Dec;41(6):1132-40. doi: 10.1590/S1677-5538.IBJU.2014.0221. PMID: 26742971; PMCID: 
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IRB ID:  MOD00007450  IRB Approved: 1/17/2024 - 9/11/2024