Efficacy of the Act of Urination to Relief the Pain During Flexible Cystoscopy Procedure.

Study Overview
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Brief Summary
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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
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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

Official Title
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Efficacy of the Act of Urination to Relief the Pain During Flexible Cystoscopy Procedure.

Conditions
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Hematuria, Bladder Ca, Bladder Stone, Urologic Diseases

Intervention / Treatment
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* Procedure: Instruction to urinate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age more 18 years old Exclusion Criteria: Analgesic use within 24hours History of stricture ,urinary tract infection, existing urethral pain Secondary procedure(exp stent, stone removal, fulguration)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Cystoscopy procedure will be done based on cystoscopy protocol. During scope procedure patient will not giving instruction to urinate during the procedure. | |
| Experimental: Experimental Arm<br>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 | Procedure: Instruction to urinate<br>* 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<br>* Other names: voiding instruction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During cystoscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During cystoscopy procedure |