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

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.

Study Overview

• Status: Recruiting
• Conditions: Urologic Diseases; Hematuria; Bladder Ca; Bladder Stone
• Intervention / Treatment: Procedure: Instruction to urinate

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 Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MUNAWWAR ADNAN DR, MD; Phone Number: +60174388516; Email: munir_120@hotmail.com

Study Locations

• Malaysia
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 15100
      • Recruiting
      • Hospital University Sains Malaysia
      • Contact: MUNAWWAR BIN MOHD ADNAN, MD; Phone Number: 0174388516; Email: munir_120@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control Arm; 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; 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; 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; Other Names: voiding instruction

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Principal Investigator: MUNAWWAR BIN ADNAN DR, MD, HUSM

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2021
• Primary Completion (ANTICIPATED): April 30, 2022
• Study Completion (ANTICIPATED): April 30, 2022

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (ACTUAL): January 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urinary Bladder Diseases; Hemorrhage; Urination Disorders; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Urologic Diseases; Hematuria; Urinary Bladder Calculi
• Other Study ID Numbers: HUSMKK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No