HematuriaNCT05207969
Efficacy of the Act of Urination to Relief the Pain During Flexible Cystoscopy Procedure.
A study testing Instruction to urinate in people with Hematuria and Bladder Ca, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
This research is about modification during routine cystoscopy (scope in the bladder) procedure [ experimental research ]. The goal of the study is to evaluate patient experience with cystoscopy by using procedural modification to reduce pain perception. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematuria, Bladder Ca, Bladder Stone
- What is being tested?
- Instruction to urinate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2021to 30 Apr 2022
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age more 18 years old
Who cannot join
- Analgesic use within 24hours
- History of stricture ,urinary tract infection, existing urethral pain
- Secondary procedure(exp stent, stone removal, fulguration)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital University Sains Malaysia
Kota Bharu, Kelantan, 15100
MUNAWWAR BIN MOHD ADNAN, MD, 0174388516, munir_120@hotmail.com
About this study
This research is about modification during routine cystoscopy (scope in the bladder) procedure [ experimental research ]. The goal of the study is to evaluate patient experience with cystoscopy by using procedural modification to reduce pain perception. The investigator aim for quality improvement of the current methods of cystoscopy to achieve a better patient experience.
Read the detailed description
Study Area
-Department of Urology, Hospital Universiti Sains Malaysia.
Study population. -Patient who is required for flexible cystoscopy procedure attending Urology Unit in Hospital USM
Participants
Inclusion Criteria :
- Adult (>18 years old)
Exclusion criteria:
- Analgesic use within 24hours
- History of stricture ,urinary tract infection, existing urethral pain
- Secondary procedure(example stent, stone removal, fulguration)
Withdrawal Criteria
- Change of mind
- Found to be outside the parameters of inclusion criteria, and inside the parameters of exclusion criteria
- Breach of Protocol
- Conditions
- Hematuria, Bladder Ca, Bladder Stone, Urologic Diseases
- Being tested
- Instruction to urinate
- Medical subject headings
- Hematuria, Urinary Bladder Neoplasms, Urinary Bladder Calculi, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instruction to urinateProcedure or surgery
Also called voiding instruction
Cystoscopy procedure will be done based on cystoscopy protocol. During scope procedure, patient will be ask to urinate and this will lead to contraction of urinary bladder and relaxation of external urethral sphincter. Scope will then pass through external urethral sphinter and go to the urinary bladder
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Cystoscopy procedure will be done based on cystoscopy protocol. During scope procedure patient will not giving instruction to urinate during the procedure. |
| Experimental Arm | Experimental | Cystoscopy procedure will be done based on cystoscopy protocol. During scope procedure, patient will be ask to urinate and this will lead to contraction of urinary bladder and relaxation of external urethral sphincter. Scope will then pass through external urethral sphinter and go to the urinary bladder Receives: Procedure: Instruction to urinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
1)To determine the efficacy of the act of urination in reducing patient urethral pain during flexible cystoscopy procedure.
To determine the efficacy of the act of urination , we will use visual analogue score (VAS) , subjective assessment for assessing the patient pain score.
Measured: During cystoscopy procedure
Secondary outcomes (1)
2)To determine the association between the act of urination with relaxation of external urethral sphincter during flexible cystoscopy procedure.
We will use electromyography (EMG) as objective assessent to determine association between act of urination and relaxation of external urethral sphinter.
Measured: During cystoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Aug 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematuriaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munawwar Bin Mohd Adnan, Universiti Sains Malaysia
- Investigators
- MUNAWWAR BIN ADNAN DR, MD, Principal investigator, HUSM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207969
- Sponsor's protocol ID
- HUSMKK
- Status last verified
- Jan 2022
- First submitted
- 29 Jun 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Act of Urination to Relief the Pain During Flexible Cystoscopy Procedure.
- ClinicalTrials.gov ID
- NCT05207969
- Acronym / sponsor ID
- HUSMKK
- Conditions
- Hematuria, Bladder Ca, Bladder Stone, Urologic Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 26 Jan 2022 (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.
This research is about modification during routine cystoscopy (scope in the bladder) procedure [ experimental research ]. The goal of the study is to evaluate patient experience with cystoscopy by using procedural modification to reduce pain perception. The investigator aim for quality improvement of the current methods of cystoscopy to achieve a better patient experience.
Detailed description
Study Area
-Department of Urology, Hospital Universiti Sains Malaysia.
Study population. -Patient who is required for flexible cystoscopy procedure attending Urology Unit in Hospital USM
Participants
Inclusion Criteria :
- Adult (>18 years old)
Exclusion criteria:
- Analgesic use within 24hours
- History of stricture ,urinary tract infection, existing urethral pain
- Secondary procedure(example stent, stone removal, fulguration)
Withdrawal Criteria
- Change of mind
- Found to be outside the parameters of inclusion criteria, and inside the parameters of exclusion criteria
- Breach of Protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Cystoscopy procedure will be done based on cystoscopy protocol. During scope procedure patient will not giving instruction to urinate during the procedure. |
| Experimental Arm | Experimental | Procedure: Instruction to urinateCystoscopy procedure will be done based on cystoscopy protocol. During scope procedure, patient will be ask to urinate and this will lead to contraction of urinary bladder and relaxation of external urethral sphincter. Scope will then pass through external urethral sphinter and go to the urinary bladder |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age more 18 years old
Key exclusion criteria (3 listed)
- Analgesic use within 24hours
- History of stricture ,urinary tract infection, existing urethral pain
- Secondary procedure(exp stent, stone removal, fulguration)
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 |
|---|---|---|
| Instruction to urinateAlso: voiding instructionCystoscopy procedure will be done based on cystoscopy protocol. During scope procedure, patient will be ask to urinate and this will lead to contraction of urinary bladder and relaxation of external urethral sphincter. Scope will then pass through external urethral sphinter and go to the urinary bladder | Procedure or surgery | Experimental Arm |
Primary outcome
1)To determine the efficacy of the act of urination in reducing patient urethral pain during flexible cystoscopy procedure.
Time frame: During cystoscopy procedure
To determine the efficacy of the act of urination , we will use visual analogue score (VAS) , subjective assessment for assessing the patient pain score.
1 secondary outcome
2)To determine the association between the act of urination with relaxation of external urethral sphincter during flexible cystoscopy procedure.
Time frame: During cystoscopy procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No
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Hematuria - Cause Not Known
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.
MUNAWWAR BIN ADNAN DR, MD principal investigator
HUSM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instruction to urinate in people with Hematuria and Bladder Ca, run by Universiti Sains Malaysia at 1 site in Malaysia.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Jan 2022. 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 Malaysia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MUNAWWAR ADNAN DR, MD (+60174388516, munir_120@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1)To determine the efficacy of the act of urination in reducing patient urethral pain during flexible cystoscopy procedure. (time frame: During cystoscopy procedure). 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 26 Jan 2022.