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

Not Applicable

• Conditions: Hematuria; Bladder Ca; Bladder Stone; Urologic Diseases
• Interventions: Procedure: Instruction to urinate

• Registration Number: NCT05207969
• Lead Sponsor: Universiti Sains Malaysia

Brief 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. 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 Timeline

• Study First Submitted: 2021-06-29
• Study Start: 2021-08-01
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-11
• Last Update Submitted: 2022-01-11
• Study First Posted: 2022-01-26
• Last Update Posted: 2022-01-26
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Arm	Instruction to urinate	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

Primary Outcome Measures

Name	Time	Method
1)To determine the efficacy of the act of urination in reducing patient urethral pain during flexible cystoscopy procedure.	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.

Secondary Outcome Measures

Name	Time	Method
2)To determine the association between the act of urination with relaxation of external urethral sphincter during flexible cystoscopy procedure.	During cystoscopy procedure	We will use electromyography (EMG) as objective assessent to determine association between act of urination and relaxation of external urethral sphinter.

Trial Locations

Locations (1)

Hospital University Sains Malaysia; 🇲🇾 Kota Bharu, Kelantan, Malaysia