Bladder CancerPhase 3NCT06301308
A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial
A Phase 3 study testing Intraurethral lidocaine gel alone, Intraurethral lidocaine gel + lidocaine 2% injection and intraurethral lidocaine gel + liquid paraffinl in people with Bladder Cancer, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about a novel application of lidocaine injection in male patients who needs rigid cycstoscopy test. The main question it aims to answer is:Does New Application of Lidocaine Liquid Provide Pain Relief for Patients During Cystoscopy? Before the cycstoscopy,Participants will be… Read more about this study
- Who is it for?
- Ages Up to 50 years, men only
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Intraurethral lidocaine gel alone, Intraurethral lidocaine gel + lidocaine 2% injection and intraurethral lidocaine gel + liquid paraffinl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 29 Feb 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 50 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male patients under the age of 50 referred for postoperative cystoscopy for bladder cancer
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn about a novel application of lidocaine injection in male patients who needs rigid cycstoscopy test. The main question it aims to answer is:Does New Application of Lidocaine Liquid Provide Pain Relief for Patients During Cystoscopy? Before the cycstoscopy,Participants will be randomly divided into three different anesthesia mode groups,namely are Group A (intraurethral lidocaine gel alone), Group B (intraurethral lidocaine gel + lidocaine 2% injection), and Group C (intraurethral lidocaine gel + liquid paraffinl).Patients only need to prepare and cooperate according to routine surgical operations，which is group B or group C.
Read the detailed description
The primary objective of this clinical trial is to investigate the efficacy of a novel application of lidocaine injection in alleviating pain for male patients undergoing rigid cystoscopy procedures. Rigid cystoscopy is a common diagnostic examination used to visualize the interior of the bladder and urethra. However, it can be associated with discomfort and pain for patients.
The central question driving this study is whether the new application of lidocaine liquid can provide effective pain relief during cystoscopy. To address this question, participants will be randomly assigned to one of three anesthesia mode groups: Group A, which will receive intraurethral lidocaine gel alone; Group B, which will receive intraurethral lidocaine gel along with lidocaine 2% injection; and Group C, which will receive intraurethral lidocaine gel along with liquid paraffin.
Those assigned to Group B or Group C will only need to prepare and cooperate according to routine surgical operations. This standardizes the pre-procedural preparation process across the study groups, ensuring consistency in the approach to anesthesia administration.
By comparing the pain levels experienced by patients in each group during cystoscopy, the study aims to determine the effectiveness of the new lidocaine application method in providing pain relief. This information will be crucial in improving the patient experience during cystoscopy procedures and potentially optimizing anesthesia protocols for future clinical practice.
- Conditions
- Bladder Cancer
- Being tested
- Intraurethral lidocaine gel alone, Intraurethral lidocaine gel + lidocaine 2% injection, intraurethral lidocaine gel + liquid paraffinl
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraurethral lidocaine gel aloneDrug
Also called Group A
participants received 10 ml of intraurethral lidocaine gel at a concentration of 2%
Intraurethral lidocaine gel + lidocaine 2% injectionDrug
Also called Group B
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.
intraurethral lidocaine gel + liquid paraffinlDrug
Also called Group C
Liquid paraffin were used to lubricate hte cystoscopy tube AND participants received 10 ml of intraurethral lidocaine gel at a concentration of 2%
| Study group | Role | What they receive |
|---|---|---|
| Intraurethral lidocaine gel alone | Sham comparator | Participants received 10 ml of intraurethral lidocaine gel at a concentration of 2% Receives: Drug: Intraurethral lidocaine gel alone |
| Intraurethral lidocaine gel + lidocaine 2% injection | Experimental | 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. Receives: Drug: Intraurethral lidocaine gel + lidocaine 2% injection |
| intraurethral lidocaine gel + liquid paraffinl | Experimental | Liquid paraffin were used to lubricate hte cystoscopy tube AND participants received 10 ml of intraurethral lidocaine gel at a concentration of 2% Receives: Drug: intraurethral lidocaine gel + liquid paraffinl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access the pain score using the Visual Analogue Scale (VAS)
Access the pain score assessed using the Visual Analogue Scale (VAS) during the procedure
Measured: 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 outcomes (1)
Postoperative complications
The second outcomes were included parameters such as field of view occlusion, duration of pain, hematuria duration, and lower urinary tract symptoms post-procedure.
Measured: Within three days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Oct 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Why it stopped: The standard measures of anaesthesia in cystoscopy are not uniform internationally, and given this, we were unable to recruit the first participant in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Shunhua, Second Xiangya Hospital of Central South University
- Investigators
- Shunhua Cheng, Study chair, Central South University,the second xiangya hospitalCan Tang, Study director, Central South University,the second xiangya hospitalShunhua Cheng, Principal investigator, Central South University,the second xiangya hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301308
- Sponsor's protocol ID
- 2022021
- Status last verified
- Apr 2024
- First submitted
- 3 Mar 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial
- ClinicalTrials.gov ID
- NCT06301308
- Acronym / sponsor ID
- 2022021
- Conditions
- Bladder Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The standard measures of anaesthesia in cystoscopy are not uniform internationally, and given this, we were unable to recruit the first participant in the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about a novel application of lidocaine injection in male patients who needs rigid cycstoscopy test. The main question it aims to answer is:Does New Application of Lidocaine Liquid Provide Pain Relief for Patients During Cystoscopy? Before the cycstoscopy,Participants will be randomly divided into three different anesthesia mode groups,namely are Group A (intraurethral lidocaine gel alone), Group B (intraurethral lidocaine gel + lidocaine 2% injection), and Group C (intraurethral lidocaine gel + liquid paraffinl).Patients only need to prepare and cooperate according to routine surgical operations，which is group B or group C.
Detailed description
The primary objective of this clinical trial is to investigate the efficacy of a novel application of lidocaine injection in alleviating pain for male patients undergoing rigid cystoscopy procedures. Rigid cystoscopy is a common diagnostic examination used to visualize the interior of the bladder and urethra. However, it can be associated with discomfort and pain for patients.
The central question driving this study is whether the new application of lidocaine liquid can provide effective pain relief during cystoscopy. To address this question, participants will be randomly assigned to one of three anesthesia mode groups: Group A, which will receive intraurethral lidocaine gel alone; Group B, which will receive intraurethral lidocaine gel along with lidocaine 2% injection; and Group C, which will receive intraurethral lidocaine gel along with liquid paraffin.
Those assigned to Group B or Group C will only need to prepare and cooperate according to routine surgical operations. This standardizes the pre-procedural preparation process across the study groups, ensuring consistency in the approach to anesthesia administration.
By comparing the pain levels experienced by patients in each group during cystoscopy, the study aims to determine the effectiveness of the new lidocaine application method in providing pain relief. This information will be crucial in improving the patient experience during cystoscopy procedures and potentially optimizing anesthesia protocols for future clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intraurethral lidocaine gel alone | Sham comparator | Drug: Intraurethral lidocaine gel aloneParticipants received 10 ml of intraurethral lidocaine gel at a concentration of 2% |
| Intraurethral lidocaine gel + lidocaine 2% injection | Experimental | Drug: Intraurethral lidocaine gel + lidocaine 2% injectionParticipants 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. |
| intraurethral lidocaine gel + liquid paraffinl | Experimental | Drug: intraurethral lidocaine gel + liquid paraffinlLiquid paraffin were used to lubricate hte cystoscopy tube AND participants received 10 ml of intraurethral lidocaine gel at a concentration of 2% |
Who may qualify
- Ages
- Up to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Male patients under the age of 50 referred for postoperative cystoscopy for bladder cancer
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraurethral lidocaine gel aloneAlso: Group Aparticipants received 10 ml of intraurethral lidocaine gel at a concentration of 2% | Drug | Intraurethral lidocaine gel alone |
| Intraurethral lidocaine gel + lidocaine 2% injectionAlso: Group Bparticipants 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. | Drug | Intraurethral lidocaine gel + lidocaine 2% injection |
| intraurethral lidocaine gel + liquid paraffinlAlso: Group CLiquid paraffin were used to lubricate hte cystoscopy tube AND participants received 10 ml of intraurethral lidocaine gel at a concentration of 2% | Drug | intraurethral lidocaine gel + liquid paraffinl |
Primary outcome
Access the pain score using the Visual Analogue Scale (VAS)
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.
Access the pain score assessed using the Visual Analogue Scale (VAS) during the procedure
1 secondary outcome
Postoperative complications
Time frame: Within three days after surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shunhua Cheng study chair
Central South University,the second xiangya hospital
Can Tang study director
Central South University,the second xiangya hospital
Shunhua Cheng principal investigator
Central South University,the second xiangya hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intraurethral lidocaine gel alone, Intraurethral lidocaine gel + lidocaine 2% injection and intraurethral lidocaine gel + liquid paraffinl in people with Bladder Cancer, run by Second Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Access the pain score using the Visual Analogue Scale (VAS) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.