Efficacy of the Act of Urination to Relief the Pain During Flexible Cystoscopy Procedure.
Primary Purpose
Hematuria, Bladder Ca, Bladder Stone
Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Instruction to urinate
Sponsored by
About this trial
This is an interventional treatment trial for Hematuria
Eligibility Criteria
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)
Sites / Locations
- Hospital University Sains MalaysiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Arm
Experimental Arm
Arm Description
Cystoscopy procedure will be done based on cystoscopy protocol. During scope procedure patient will not giving instruction to urinate during the 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05207969
First Posted
June 29, 2021
Last Updated
January 11, 2022
Sponsor
Universiti Sains Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT05207969
Brief Title
Efficacy of the Act of Urination to Relief the Pain During Flexible Cystoscopy Procedure.
Official Title
Efficacy of the Act of Urination to Relief the Pain During Flexible Cystoscopy Procedure.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematuria, Bladder Ca, Bladder Stone, Urologic Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Cystoscopy procedure will be done based on cystoscopy protocol. During scope procedure patient will not giving instruction to urinate during the procedure.
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Instruction to urinate
Other Intervention Name(s)
voiding instruction
Intervention Description
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
Primary Outcome Measure Information:
Title
1)To determine the efficacy of the act of urination in reducing patient urethral pain during flexible cystoscopy procedure.
Description
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 Outcome Measure Information:
Title
2)To determine the association between the act of urination with relaxation of external urethral sphincter during flexible cystoscopy procedure.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MUNAWWAR ADNAN DR, MD
Phone
+60174388516
Email
munir_120@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MUNAWWAR BIN ADNAN DR, MD
Organizational Affiliation
HUSM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital University Sains Malaysia
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
15100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MUNAWWAR BIN MOHD ADNAN, MD
Phone
0174388516
Email
munir_120@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of the Act of Urination to Relief the Pain During Flexible Cystoscopy Procedure.
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