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

Urologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05207969
• Other study ID #: HUSMKK
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: January 2022
• Source: Universiti Sains Malaysia
• Contact: MUNAWWAR ADNAN DR, MD
• Phone: +60174388516
• Email: munir_120[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigator aim for quality improvement of the current methods of cystoscopy to achieve a better patient experience.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hematuria
• Urologic Diseases

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Malaysia	Hospital University Sains Malaysia	Kota Bharu	Kelantan

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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