A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial
Phase: PHASE3
Conditions: Bladder Cancer
Sponsor: Second Xiangya Hospital of Central South University

A novel application of 2% lidocaine injection for male rigid cycstoscopy-a
patient-blinded randomised trial
1.0
January 1, 2024
The Second Xiangya Hospital
of Central South University
Multi-center （Lead）
Multi-center （Participants）
Single-center
Interventional/randomized
controlled clinical trial
Cheng Shunhua, Associate
Chief Nurse
UROLOGY
2022021
The Second Xiangya Hospital of Central South University

The study protocol submitted herein was developed by the investigator, Cheng
Shunhua, and the protocol was developed with reference to the requirements of
relevant national clinical research regulations. The above persons/units have approved
the content of this protocol and agreed to submit it to the Second Xiangya Hospital of
Central South University to apply for a clinical research project
(initiated by the
investigator).
In order to ensure the authenticity and safety of the data of the clinical research, the
investigator guarantees that the submitted information is true, legal, valid and objective,
without
falsification,
fabrication,
alteration,
tampering
and
concealment,
and
guarantees that the information and documents of
the project filled
in CTMS,
"Medical Research Registration and Filing Information System" are the same as the
paperinformationonfile,andthathe/she will Strictly follow the protocol design and plan,
submit the study progress report/completion report on time, and report to the Ethics
Committee ina timely manner in case of protocol changes, adverse events or any factors
affecting the safety of the study.

1.Background
2.Research Programs and Plans
2.1 Subject of study
2.2 Arms and interventions
2.3 Outcome Measures
2.3.1 Primary Outcome Measure
2.3.2 Secondary Outcome Measures
3.Data management and quality control

1.Background
Cystoscopy is a routine outpatient procedure in urology used to assess the
health of the bladder mucosa and lower urethra. However, due to the inherent
pain associated with this procedure, significant challenges exist. Not only
does this cause inevitable discomfort for patients, but it also can lead to patients
missing follow-up opportunities, thereby impacting the overall effectiveness of
the surgery.
Pain is typically categorized as mild or moderate. Flexible cystoscopy, often
performed
in
outpatient
settings,
is
one
measure
aimed
at alleviating
procedural
discomfort.
However,
despite
the
use
of
these
advanced
instruments,
patient-reported
discomfort
remains
similar
to
traditional
methods.
Notable
gender
differences
suggest
that
males experience
greater pain compared to females. The most painful stage is during cystoscope
insertion, particularly when passing through the external urethral sphincter.
We conducted a study to evaluate the comparative efficacy of lidocaine gel and
lidocaine
injection
in
irrigation
during
outpatient
rigid
cystoscopy
examination.
2.1 Subject of study
Subject of study：Male patients under 50 years of age with diagnosed with
bladder tumors requiring postoperative cystoscopy attending the Department
of Urology at the Second Xiangya Hospital from January 2024 to present.
The inclusion criteria were: 1. patients with bladder tumors need to undergo
cystoscopy after surgery; 2. male patients, aged 18-50 years old, meeting the
ethical criteria, and all subjects participated voluntarily and signed the informed
consent form at the same time; 3. no adjuvant treatments, such as radiotherapy,
chemotherapy, etc., prior to the surgery; 4. complete medical history data.
Exclusion criteria:1. Other evident causes contributing to lower urinary
tract symptoms, such as obvious glandular cystitis and severe urinary tract
infections.2.Excessiveprostatichyperplasia.3.Urethral stricture. 4. A history of
prior urethral surgeries. 5. Uncontrolled hypertension, cardiac conditions,
and chronic obstructive pulmonary disease.

Arms
Assigned Interventions
Sham
Comparator:
Intraurethral lidocaine gel
alone
Participants received 10 ml
of intraurethral lidocaine
gel at a concentration of 2%
Drug: Intraurethral lidocaine gel
alone
participants received 10 ml of
intraurethral lidocaine gel at a
concentration of 2%
Other Names:
Group A
Experimental:
Intraurethral lidocaine gel+
lidocaine 2% injection
Participants received 10 ml
of intraurethral lidocaine gel at a
concentration of 2% and using
the injection of lidocaine 2% to
irrigate the
urethra usinga20mlsyringe.
Drug: Intraurethral lidocaine gel
+ lidocaine 2% injection
participants received 10 ml of
intraurethral lidocaine gel at a
concentration of 2% and using the
injection of lidocaine 2% to irrigate
the urethra using a 20 ml syringe.
Other Names:
Group B
Experimental:
intraurethral lidocaine gel+
Drug: intraurethral lidocaine gel
+ liquid paraffinl

liquid paraffinl
Liquid paraffin were used to
lubricate hte
cystoscopy tube
AND
participants received
10
ml
of intraurethral
lidocaine gel
at a concentration of 2%
Liquid
paraffin
were
used
to
lubricate
hte
cystoscopy
tube
AND
participants
received
10
ml
of
intraurethral lidocaine gel at a
concentration of 2%
Other Names:
Group C
2.3.1 Primary Outcome Measure:
Access the pain score using the Visual Analogue Scale (VAS) during the
procedure.Time Frame: The procedure was evaluated using the visual
analogue scale immediately afterward (referred to as "during the
procedure" for the study's purposes) and again five minutes later.
2.3.2 Secondary Outcome Measures:
Postoperative complications including included parameters such as field ofview
occlusion,durationofpain,hematuriaduration,and lowerurinary tract symptoms
post-procedure. Time Frame: Within three days after surgery.
The investigator loads data into the case report form in a timely, complete,
correct, and legible manner based on the subject's original observation record.
The questionnaire after review and signature by the ombudsman shouldbe sent
totheclinicalresearchdatamanager inatimely manner.
The entry isdoneusingtheappropriatedatabase systemoftwo-person dual-
machine entry, after which the database is compared twice, during which the
monitor is notified promptly if any problems are found, and the researcher is
asked to make a reply. The exchange of questions and answers between them
should be in the form of a questionnaire, which should be kept for reference.

Statistical Analysis Plan
After data collection, descriptive and analytical analyses were conducted
using SPSS version 26. Between-group differences were assessed using
independent samples analysis of variance (ANOVA). Due to the significant
result of the Shapiro-Wilk test, non-parametric tests (Kruskal-Wallis test) were
employed for statistical analysis. Dwass-Steel-Critchlow-Fligner test was used
as a post-hoc analysis to delineate specific between-group differences in mean
pain scores and other surgery-related data. Data are presented as mean (M) ±
standard deviation (SD).

Informed Consent Form
Dear Subject/Volunteer:
Greetings!
We would like to invite you to participate in a medical study called "A novel
application of 2% lidocaine injection for male rigid cycstoscopy-a patient-blinded
randomized trial We are inviting you to participate in a medical research study called
"A novel application of 2% lidocaine injection for male rigid cycstoscopy-a patient-
blinded randomized trial" conducted by the Department of Urology, Second Xiangya
Hospital, Central South University. Whether or not you participate in this study is
based on your personal wishes. In order to help you understand this study, this
informed consent form will give you a detailed description of the purpose of the study
and the process of conducting the study, as well as a description of the possible risks
of participating in this study and the possible benefits. If you are interested, please
read the rest of the information carefully and any questions you may have will be
answered by the study doctor and researchers. If all your questions about this study
have been answered to your satisfaction and you are considering participating in this
study, you may sign this informed consent form.
1. Why was this study conducted?
Cystoscopy is a routine outpatient procedure in urology used to assess the health
of the bladder mucosa and lower urethra. However, due to the inherent pain associated
with this procedure, significant challenges exist. Not only does this cause inevitable
discomfort for patients, but it also can lead to patients missing follow-up opportunities,
thereby impacting the overall effectiveness of the surgery. Pain is typically
categorized as mild or moderate. Flexible cystoscopy, often performed in outpatient
settings, is one measure aimed at alleviating procedural discomfort. However, despite
the use of these advanced instruments, patient-reported discomfort remains similar to
traditional methods. Notable gender differences suggest that males experience greater
pain compared to females. The most painful stage is during cystoscope insertion,
particularly when passing through the external urethral sphincter. We conducted a
study to evaluate the comparative efficacy of lidocaine gel and lidocaine injection in
irrigation during outpatient rigid cystoscopy examination
2. The process of this study
Subject of study：Male patients under 50 years of age with diagnosed with bladder
tumors requiring postoperative cystoscopy attending the Department of Urology at the
Second Xiangya Hospital from January 2024 to present.
The inclusion criteria were: 1. Patients with bladder tumors need to undergo
cystoscopy after surgery; 2. male patients, aged 18-50 years old, meeting the ethical
criteria, and all subjects participated voluntarily and signed the informed consent form
at the same time; 3. no adjuvanttreatments, such as radiotherapy, chemotherapy, etc.,
prior to the surgery; 4. complete medical history data.

Exclusion criteria:1. Other evident causes contributing to lower urinary tract
symptoms, such as obvious glandular cystitis and severe urinary tract infections. 2.
Excessive prostatic hyperplasia. 3. Urethral stricture. 4. A history of prior urethral
surgeries. 5. Uncontrolled hypertension, cardiac conditions, and chronic obstructive
pulmonary disease.
Primary Outcome Measure: Access the pain score using the Visual Analogue Scale
(VAS) during the procedure.Time Frame: The procedure was evaluated using the
visual analogue scale immediately afterward (referred to as "during the procedure" for
the study's purposes) and again five minutes later.
Secondary Outcome Measures:
Postoperative complications including included parameters such as field of view
occlusion, duration of pain, hematuria duration, and lower urinary tract symptoms post
-procedure. Time Frame: Within three days after surgery.
3. Plan for dealing with problems related to the course of this study
If you experience problems as a result of participating in the study, your doctor
will immediately provide the necessary medical treatment. In the event of a study-
related injury, the injury will be evaluated and determined by medical authorities in
accordance with applicable laws and regulations. Please contact your physician
promptly.
4.Information Confidentiality
Relevant laws in China provide guarantees for the security of privacy, data and
authorized access, and we will strictly follow the requirements of the law to maintain
the confidentiality of your information when collecting and processing research
information related to you. Your name, ID number, address, telephone number, or any
information that can directly identify you in the research records will not be disclosed
outside of the Second Xiangya Hospital of Central South University unless required
by relevant laws. For research information about you that is passed to the Second
Xiangya Hospital of Central South University, we will use a number instead to hide
your personal information, and the coded information will be properly stored in the
Department of Urology of the Second Xiangya Hospital of Central South University.
Your identity will not be disclosed when the research data obtained from this study is
published in scientific conferences or scientific journals. However, your records may

be reviewed to ensure that the study complies with relevant laws and regulations. The
reviewers include the relevant national regulatory authorities and the Clinical
Research Ethics Committee of the Second Xiangya Hospital of Central South
University.
5. Refusing to participate or withdrawing from the study
Participation in this study is based solely on your own wishes. You may refuse to
participate or withdraw from the study in any way at any stage of the trial without
discrimination or retaliation, and your medical treatment and rights will not be
affected, except that you will be required to return any unused study medications and
devices.
If you have a serious adverse reaction, or if your study doctor feels that it is not
in your best interest to continue in the study, he/she may decide to withdraw you from
the study. You will be notified promptly if these circumstances exist, and your study
doctor will discuss with you the other options you have. If your doctor believes that a
sudden discontinuation of the trial will affect your health, he/she may ask you to come
to the hospital for a check-up before stopping the trial. No new data will be collected
on subjects after they have been withdrawn from the trial.
6. Rights and benefits
As this is an interventional study, it will be clarified that the patient has no history of
allergy to the drug (lidocaine) and will be treated unconditionally by our specialists in
the event of an adverse reaction. In the event of any adverse reaction or complication
during a routine cystoscopy, our specialists will provide unconditional treatment. We
would like to thank you for your participation in scientific research and your
contribution to the development of medicine!

Subject Statement and Signature Acknowledgment:
I have read this informed consent form carefully and have had the opportunity
to ask questions, which have been thoroughly explained to me and answered by
the investigator. I understand that participation in this study is completely
voluntary, that I may withdraw at any time without giving a reason, and that my
medical and legal rights will not be affected. I give permission for the sponsor,
the researcher, and the Health Inspectorate to review my medical records, and I
understand that the researcher will take all reasonable steps to protect my
privacy. I agree to participate in this study and will receive a signed copy of the
completed informed consent form.
Subject's name (in print):
Signature (handwritten): Date:
Contact Phone Number:
Subject's legal representative's name (in print):
Signature (handwritten): Date:
Contact phone number:
Investigator Statement and Signature Acknowledgment:
I or my investigator has fully explained and justified to this subject the purpose
of this clinical trial, the study process, and the possible risks and benefits to the
subject of participating in this trial, and has answered all relevant questions from
the subject.
Project Designated Contact: Contact Phone:
Researcher's name (in print):
Signature (handwritten): Date:
Contact phone number: