Intradetrusor Onabotulinumtoxin A (Botox) at the Time of Transurethral Resection of the Prostate or Transurethral Waterjet Ablation of the Prostate for Mixed Lower Urinary Tract Symptoms
Conditions: Benign Prostatic Hypertrophy (BPH), Lower Urinary Track Symptoms
Sponsor: Benaroya Research Institute

 
 
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FULL PROTOCOL TITLE 
 
Intradetrusor Onabotulinumtoxin A (Botox) at the time of Transurethral Resection of 
the Prostate or Transurethral Waterjet Ablation of the Prostate for Mixed Lower Urinary 
Tract Symptoms  
 
 
 
Principal Investigator: 
 
Thomas W. Fuller, MD 
Virginia Mason Franciscan Health 
Department of Urology  
1100 Ninth Ave C7-URO 
Seattle, WA 98101 
will.fuller@commonspirit.org 
206-223-6772 
 
 
Supported by: 
 
Benaroya Research Institute 
 
 
 
 
 
 
 
 
 
 
 

 
 
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TABLE OF CONTENTS 
 
CLINICAL SITES PARTICIPATING IN THE STUDY  
 
 
 
 
 
PROTOCOL SYNOPSIS 
 
1. STUDY OBJECTIVES 
 
1.1 Primary Objectives 
1.2 Secondary Objectives 
1.3 Primary Endpoint 
1.4 Secondary Endpoints 
 
2. BACKGROUND 
 
2.1  Rationale 
2.2  Supporting Data 
 
3. STUDY DESIGN 
3.1 Observational Study  
 
4. TARGET STUDY POPULATION SPECIFICS 
 
4.1   Inclusion Criteria 
4.2   Exclusion Criteria 
4.3   Data Collection Procedures 
 
5. STATISTICAL CONSIDERATIONS 
 
5.1 Hypothesis 
5.2 Data Analysis 
 
6. DATA COLLECTION 
 
6.1 Records to be kept 
6.2 Secure storage of data 
6.3 Quality Assurance 
 
7. HUMAN SUBJECTS 
 
7.1 Institutional Review Board (IRB) Review and Informed Consent 
7.2 Potential Risks 
7.3 Subject Confidentiality 
7.4 Study Modification/Discontinuation 

 
 
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8. PUBLICATION OF RESEARCH FINDINGS 
 
9. REFERENCES 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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CLINICAL SITES PARTICIPATING IN THE STUDY 
 
Virginia Mason Franciscan Health 
 
Principal Investigator:  
Thomas W. Fuller, MD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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PROTOCOL SYNOPSIS 
TITLE 
Intradetrusor Onabotulinumtoxin A (Botox) at the time of 
Transurethral Resection of the Prostate or Transurethral Waterjet 
Ablation of the Prostate for Mixed Lower Urinary Tract Symptoms  
 
NUMBER OF SITES 
1 
RATIONALE 
Patients with longstanding obstructive lower urinary tract symptoms 
(LUTS) due to benign prostatic hypertrophy (BPH) can also develop 
symptoms of overactive bladder syndrome (OAB). Transurethral 
resection of the prostate (TURP) and Transurethral Waterjet Ablation 
of the Prostate (Aquablation) are amongst the gold standard surgical 
treatments for BPH. However, in the immediate post-operative period, 
TURP  and Aquablation can also include OAB-like symptoms, 
including urinary frequency and urgency. For men with baseline OAB 
symptoms, this initial worsening of symptoms can be distressing. 
 
Botox is an FDA approved medication with on-label indications to 
treat overactive bladder.  
 
The purpose of this study is to evaluate the outcomes of men who 
have Botox concurrent with their TURP or Aquablation. 
STUDY DESIGN 
This is an observational study to close knowledge gaps on the 
outcomes of patients who undergo these  procedures concurrently. 
PRIMARY 
OBJECTIVE 
To identify whether concurrent Botox and TURP  or Aquablation 
are effective at reducing post-operative irritative voiding symptoms. 
SECONDARY 
OBJECTIVES 
To identify whether concurrent Botox and TURP or Aquablation 
lead to higher rates of urinary retention, longer hospitalization. 
NUMBER OF 
SUBJECTS 
The goal will be to enroll 20 subjects  
SELECT  
SUBJECT ENTRANCE 
CRITERIA 
Inclusion Criteria: 
1. 
Male ≥ 18 years of age and being scheduled to undergo TURP 
or Aquablation and Botox procedure. 
2. 
Written informed consent obtained from subject and ability for 
subject to comply with the requirements of the study. 
 
Exclusion Criteria: 
3. 
Non-English speaking 
4. 
Presence of a condition or abnormality that in the opinion of 
the Investigator would compromise the safety of the patient or 
the quality of the data. 

 
 
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5. 
History of receiving Botox in the bladder, within the previous 
12 months. 
  
DURATION OF 
SUBJECT 
PARTICIPATION 
AND DURATION OF 
STUDY 
Total expected duration of participation is four months. 
The study is expected to last approximately 2 years. 
CONCOMITANT 
MEDICATIONS 
All concomitant medications are allowed. 
PRIMARY ENDPOINT 
• 
1 week post-operative visit for: trial of void, to assess for rates of 
postoperative urinary retention. 
SECONDARY 
ENDPOINTS 
• 
4 and 12 week post-operative visits for: post void residual 
assessment via bladder scan, AUA symptom score, PGI-I, UDI-6, 
and VM Post Procedure questionnaires will be administered 
• 
Hospitalization readmission rates, urinary retention episodes 
SAFETY 
EVALUATIONS 
All subjects will be closely monitored per standard of care by their 
urology provider.  
PLANNED INTERIM 
ANALYSES  
None 
STATISTICS 
Primary Analysis Plan 
Descriptive statistics will be performed for demographic and survey 
data.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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1. 
STUDY OBJECTIVES 
1.1 
Primary Objectives 
To identify whether concurrent Botox and TURP or Aquablation are 
effective at reducing post-operative irritative voiding symptoms. 
1.2 
Secondary Objectives 
To identify whether concurrent Botox and TURP or Aquablation lead to 
higher rates of urinary retention, longer hospitalization. 
1.3 
Primary Endpoint 
1 week post-operative visit for: trial of void, to assess for rates of postoperative 
urinary retention. 
1.4 
 Secondary Endpoints 
Four and twelve-week post-op visits when AUA symptom score, VM Post 
Procedure Questionnaire, PGI-I, and UDI-6 questionnaires will be 
administered. Post void residual obtained via bladder scan. 
Hospitalization readmission rates, urinary retention episodes.  
2. 
BACKGROUND 
2.1 
Rationale 
Patients with longstanding obstructive lower urinary tract symptoms (LUTS) 
due to benign prostatic hypertrophy (BPH) can also develop symptoms of 
overactive bladder syndrome (OAB). Transurethral resection of the prostate 
(TURP) and Transurethral Waterjet Ablation of the Prostate (Aquablation) 
are amongst the gold standard surgical treatments for BPH. However, in the 
immediate post-operative period, TURP and Aquablation can also include 
OAB-like symptoms, including urinary frequency and urgency. For men with 
baseline OAB symptoms, this initial worsening of symptoms can be 
distressing. 
Botox is an FDA approved medication with on-label indications to treat 
overactive bladder.  
The purpose of this study is to evaluate the outcomes of men who have 
Botox concurrent with their TURP or Aquablation. 
2.2 
Supporting Data 
Benign prostatic hypertrophy (BPH) is the natural growth of the prostate in 
aging men. BPH can eventually lead to an obstructed urinary stream, urinary 

 
 
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retention, and renal damage (1). It can additionally lead to both a 
hypocontractile as well as a hypercontractile, or overactive bladder (OAB). 
OAB is defined by irritative voiding symptoms, such as urinary frequency, 
urinary urgency, urge incontinence, and nocturia (2).  
Transurethral resection of the prostate and Aquablation are endoscopic 
procedures. In the case of TURP, a camera and resecting tool (resectoscope) 
are introduced via the urethra and the overgrown prostate is removed. This 
procedure is performed in the operating room under general or spinal 
anesthesia. Aquablation is performed by placing a camera in the urethra and 
vaporizing prostatic tissue with a pressurized beam of water. Transurethral 
resection of the prostate and Aquablation are considered amongst the gold 
standard treatment for BPH and obstructive LUTS (3,4,5). 
However, for men with BPH and OAB, surgical treatment of BPH alone may 
not alleviate symptoms of overactivity (6). Furthermore, in the immediate 
post-operative period, TURP and Aquablation can exacerbate symptoms of 
overactivity (7), causing distress to patients. 
Overactive bladder has its own treatment pathway as outlined in the combined 
AUA/SUFU guideline (8,9). Botox is administered as a 100 U starting dose 
via an endoscopic approach and can be up-titrated. The effect lasts, on 
average, 6-9 months at which point the injection can be repeated. Typically, 
Botox injection is well tolerated and can be performed in the clinic with local 
anesthesia, although some patients prefer Botox injection in the operating 
room (10). Recently, there has been rising concern regarding the safety profile 
of second line OAB treatments and a push to move to third line treatments for 
long-term management (11). 
Currently, there is no data on the treatment outcomes or patient satisfaction of 
performing Botox at the time of TURP or Aquablation. 
3. 
STUDY DESIGN 
 
3.1 
Observational Study 
 
An observational study of the effect of Botox injection at the time of TURP 
or Aquablation will be performed.  
 
If deemed eligible, participants will be invited to participate in this trial. The 
decision to accept or decline participation in the study will have no impact on 
whether they receive either treatment. After informed consent is obtained, 
patients will be administered the AUA symptom score and the Urinary 
Distress Inventory Short Form (UDI-6) as measures of baseline symptom 
severity and bother. 
 

 
 
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The International Prostate Symptom Score (IPSS) is a questionnaire that is 
widely used to assess LUTS in patients and assesses for incomplete emptying, 
frequency, intermittency, urgency, weak stream, hesitancy, and nocturia. The 
AUA quality of life score (AUA-QoL) asks how these symptoms affect 
quality of life. When administered as a combined questionnaire, this is 
referred to as the AUA symptom score. These scores are summed to produce 
an overall severity score, which can categorize patients as having mild (score 
0-7), moderate (8-19) or severe (20-35) LUTS (12). The AUA symptom score 
is a benchmark in defining the severity of symptoms, and collection of these 
scores is recommended in the AUA guidelines as part of the initial 
management of BPH (3,4,13). The UDI-6 is a validated short form of the 
urogenital distress inventory, and it assesses for the impact and severity of 
urinary incontinence (14). 
 
Participants will then undergo their TURP or Aquablation and Botox 
procedure with one of three surgeons in the department of Urology at Virginia 
Mason.  
 
At approximately four weeks post-op, participants will have a visit with their 
provider. Symptoms will be assessed by re-administering the AUA symptom 
score, the UDI-6, PGI-I and the VM Post-Procedure Questionnaire to assess 
for change in symptoms as well as satisfaction with their procedure.  
 
Participants will then have an approximate 3 month post-op visit, at which 
time the questionnaires will be re-administered. Patients will have the 
opportunity to follow-up with their provider sooner, if needed, based on 
individual symptoms. 
 
The total expected duration of participation for any given participant is 4 
months. 
 
Demographic data, including comorbidities, urodynamics results, post-void 
residual, uroflow, operative length, estimated blood loss, length of stay, 30 
day readmission rate, and 30 day rate of urinary retention will be collected for 
each subject via the electronic medical record.  
 
All data will be entered into a secure password-protected clinical research 
database maintained on a Virginia Mason computer.  
The goal is to enroll 20 patients based on an estimation of eligible subjects 
seen within the Virginia Mason urology outpatient clinic. The rate of 
enrollment is expected to be 1-2 patients per month.  
 
We will be evaluating the impact of Botox concurrent with TURP or 
Aquablation relative to published rates of overactivity and bother after TURP 
or Aquablation alone.  

 
 
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4. 
TARGET STUDY POPULATION SPECIFICS 
4.1 
Inclusion Criteria 
1. 
Male ≥ 18 years of age, and being scheduled to undergo TURP or 
Aquablation  and Botox procedure. 
2. 
Written informed consent obtained from subject and ability for subject to 
comply with the requirements of the study. 
 
4.2 
Exclusion Criteria 
1. 
Non-English Speaking 
2. 
Presence of a condition or abnormality that in the opinion of the Investigator 
would compromise the safety of the patient or the quality of the data. 
3. 
History of receiving Botox in the bladder, within the previous 12 months. 
4.3 
Data Collection Procedures 
Virginia Mason Urology providers will identify patients for potential study 
participation.   
Informed consent will be obtained for all subjects who wish to participate in 
this trial. Upon consent, study staff will obtain baseline and demographic data, 
administer AUA symptom score and the UDI-6. At follow up visits, the AUA 
symptom score, UDI-6, PGI-I, and VM post-procedure questionnaire will be 
obtained for participating patients. Additional data points under study will be 
obtained from the subject’s electronic medical record. 
5. 
STATISTICAL CONSIDERATIONS 
5.1 
Hypotheses 
a. There is a high rate of bother from OAB symptoms in men with 
BPH 
b. Botox injection at the time of TURP or Aquablation  will 
improve irritative symptoms as compared to baseline. 
c. Botox injection at the time of TURP or Aquablation  will not 
increase procedural morbidity, urinary retention rate, or 
readmission rate. 
d. Plan for future randomized, single-blind study to better evaluate 
symptomatic improvement pending the results of the study.  

 
 
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5.2 
Data Analyses 
Descriptive statistics will be performed for demographic and survey data. 
Additional analyses may be performed as appropriate.  
6. 
DATA COLLECTION 
6.1 
Records to be kept 
Clinical and demographic data is available through electronic medical records 
and will be entered directly into the study database. Any paper study 
documents that are generated, such as the questionnaires, will be securely 
stored and archived for 10 years following study completion.  
6.2 
Secure Storage of Data 
All study data will be entered into a secure password-protected clinical 
research database maintained on a Virginia Mason computer. No PHI will be 
transferred outside of Virginia Mason. 
6.3 
Quality Assurance 
The Clinical Research Program will assess the risk of this trial and will devise 
and implement an internal monitoring and/or auditing plan for this trial. This 
plan will be revised as necessary during the life of the trial based upon a 
variety of factors, including but not limited to: protocol amendments, staff 
turnover, enrollment metrics, and compliance issues noted.  
7. 
HUMAN SUBJECTS 
7.1 
Institutional Review Board (IRB) Review and Informed Consent 
This protocol and informed consent document/study information sheet and any 
subsequent modifications will be reviewed and approved by the IRB at 
Benaroya Research Institute at Virginia Mason prior to implementation. 
Informed consent will be obtained from all subjects prior to study entry 
following Good Clinical Practice and FDA guidelines. 
7.2 
Potential Risks 
The risks associated with the completion of questionnaires are the potential to 
feel uncomfortable or upset and loss of confidentiality. 
7.3 
Subject Confidentiality 
All paper records will be kept in a file cabinet within secure Virginia Mason 
offices during the trial. The database will be maintained on a Virginia Mason 
computer located on the secure Virginia Mason maintained network, which 
requires user login for access. Clinical information will not be released 
without written permission of the subject, except as necessary for monitoring 

 
 
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by the IRB, or CRP. All paper study records will be securely archived by CRP 
for 10 years following completion of the study. 
7.4 
Study Modification/Discontinuation 
The study may be modified or discontinued at any time by the IRB or 
Investigator, as part of their duties to ensure that research subjects are 
protected. 
8. 
PUBLICATION OF RESEARCH FINDINGS 
Publication of the results of this trial will be governed by the policies and 
procedures of the journal for which it is submitted. Any presentation, abstract, 
or manuscript will be made available for review by the Benaroya Research 
Institute IRB. 
9. 
REFERENCES 
1. 
Ng M, Baradhi KM. Benign Prostatic Hyperplasia. 2022 Aug 8. In: StatPearls 
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32644346.  
2. 
Chen LC, Kuo HC. Pathophysiology of refractory overactive bladder. Low 
Urin Tract Symptoms. 2019 Sep;11(4):177-181. doi: 10.1111/luts.12262. 
Epub 2019 Mar 22. PMID: 30900373. 
3. 
Lerner LB, McVary, KT, Barry MJ et al: Management of lower urinary tract 
symptoms attributed to benign prostatic hyperplasia:  Make it since she 
anything that change in point being between resident it level at and exchanged 
between if something to do it and it would not is I am still and she feels with 
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4. 
Lerner LB, McVary, KT, Barry MJ et al: Management of lower urinary tract 
symptoms attributed to benign prostatic hyperplasia: AUA Guideline part II, 
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5. 
Gilling PJ, Barber N, Bidair M et al. Five-year outcomes for Aquablation 
therapy compared to TURP: results from a double-blind, randomized trial in 
men with LUTS due to BPH. Can J Urol. 2022 Feb;29(1):10960-10968.  
6. 
Cornu JN, Grise P. Is benign prostatic obstruction surgery indicated for 
improving overactive bladder symptoms in men with lower urinary tract 
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10.1097/MOU.0000000000000249. PMID: 26574877. 

 
 
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7. 
Kim SJ, Al Hussein Alawamlh O, Chughtai B, Lee RK. Lower Urinary Tract 
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8. 
Lightner DJ, Gomelsky A, Souter L et al: Diagnosis and treatment of 
overactive bladder (non-neurogenic) in adults: AUA/SUFU Guideline 
amendment 2019. J Urol 2019; 202: 558. 
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Gormley EA, Lightner DJ, Burgio KL et al: Diagnosis and treatment of 
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Al-Shaiji TF. Intradetrusor injection of botulinum toxin for the management 
of refractory overactive bladder syndrome: an update. Surg Innov. 2013 
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Zillioux J, Welk B, Suskind AM, Gormley EA, Goldman HB. SUFU white 
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Palnaes H.C., Klarskov P.: The accuracy of the frequency–volume chart: 
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Yap TL, Cromwell DA, Brown C, van der Meulen J, Emberton M. The 
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Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms 
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