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Status unknownNCT05207969Updated Jan 26, 2022

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

An interventional study of Instruction to urinate in Hematuria, Bladder Ca and Bladder Stone, sponsored by Universiti Sains Malaysia. Status unknown at 1 site in Malaysia. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-26.

Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Hematuria
  • Bladder Ca
  • Bladder Stone
  • Urologic Diseases
03

In context

Urologic Diseases

193 studies on the registry are indexed under Urologic Diseases; 51 are open to participants now.

This study's planned enrollment of 58 is below the median of 80 across 135 interventional studies indexed under Urologic Diseases.

Browse Urologic Diseases studies →

Lead sponsor

Universiti Sains Malaysia is the lead sponsor of 171 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • age more 18 years old

Exclusion criteria

Exclusion Criteria:

  • Analgesic use within 24hours
  • History of stricture ,urinary tract infection, existing urethral pain
  • Secondary procedure(exp stent, stone removal, fulguration)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureInstruction 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

    Also known as: voiding instruction

06

What researchers measure

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.

    Time frame: 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.

    We will use electromyography (EMG) as objective assessent to determine association between act of urination and relaxation of external urethral sphinter.

    Time frame: During cystoscopy procedure

07

Study locations

1 of 1 sites recruiting
  • Hospital University Sains Malaysia
    Kota Bharu, Kelantan 15100, Malaysia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05207969
Lead sponsor
Universiti Sains Malaysia
Responsible party
Munawwar Bin Mohd Adnan (Principal Investigator, Universiti Sains Malaysia) — Principal investigator
First posted
Jan 26, 2022
Start date
Aug 1, 2021
Primary completion
Apr 30, 2022 (estimated)
Completion
Apr 30, 2022 (estimated)
Last update
Jan 26, 2022

Study contacts

MUNAWWAR ADNAN DR, MD
Contact
munir_120@hotmail.com
+60174388516
MUNAWWAR BIN ADNAN DR, MD
principal investigator · HUSM

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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