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

NCT05207969 | Unknown DMC

• 1 other identifier: HUSMKK
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematuria; Bladder Ca; Bladder Stone; Urologic Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 2)To determine the association between the act of urination with relaxation of external urethral sphincter during flexible cystoscopy procedure.

  During cystoscopy procedure

Study Arms (2)

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

Procedure: Instruction to urinate

Interventions

Instruction to urinate PROCEDURE

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

Also known as: voiding instruction

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age more 18 years old

You may not qualify if:

• Analgesic use within 24hours
• History of stricture ,urinary tract infection, existing urethral pain
• Secondary procedure(exp stent, stone removal, fulguration)

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospital University Sains Malaysia

Kota Bharu, Kelantan, 15100, Malaysia

RECRUITING

MeSH Terms

Conditions

Hematuria; Urinary Bladder Neoplasms; Urinary Bladder Calculi; Urologic Diseases

Condition Hierarchy (Ancestors)

Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urinary Calculi; Urolithiasis; Calculi; Pathological Conditions, Anatomical

Study Officials

• MUNAWWAR BIN ADNAN DR, MD

  HUSM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MUNAWWAR ADNAN DR, MD

CONTACT

+60174388516; munir_120@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: January 26, 2022
• Study Start: August 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)