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

Sponsor
Universiti Sains Malaysia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05207969
Collaborator
(none)
58
Enrollment
1
Location
2
Arms
8.9
Anticipated Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Instruction to urinate
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of the Act of Urination to Relief the Pain During Flexible Cystoscopy Procedure.
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital University Sains Malaysia Kota Bharu Kelantan Malaysia 15100

    Sponsors and Collaborators

    • Universiti Sains Malaysia

    Investigators

    • Principal Investigator: MUNAWWAR BIN ADNAN DR, MD, HUSM

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Munawwar Bin Mohd Adnan, Principal Investigator, Universiti Sains Malaysia
    ClinicalTrials.gov Identifier:
    NCT05207969
    Other Study ID Numbers:
    • HUSMKK
    First Posted:
    Jan 26, 2022
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urologic Diseases
    Hematuria
    Urinary Bladder Calculi

    Study Results

    No Results Posted as of Jan 26, 2022