Patient Position and Invasive Urodynamic Study Results in Males
Primary Purpose
Lower Urinary Tract Symptoms, Diagnosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Invasive Urodynamic Study
Sponsored by
About this trial
This is an interventional diagnostic trial for Lower Urinary Tract Symptoms
Eligibility Criteria
Inclusion Criteria: Males over 18 years old and capable of standing during test Exclusion Criteria: Patients not able to stand up during the test
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Invasive urodynamic study will be performed firstly in sitting position. Then, repeated in standing position.
Invasive urodynamic study will be performed firstly in standing position. Then, repeated in sitting position.
Outcomes
Primary Outcome Measures
Invasive urodynamic study
Sitting position
Invasive urodynamic study
Standing position
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05947565
Brief Title
Patient Position and Invasive Urodynamic Study Results in Males
Official Title
Will Performing Invasive Urodynamic Study in Sitting or Standing Position Effect the Results in Males?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Koç University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to learn whether the change or patient position might effect the results of invasive urodynamic study in males.
Detailed Description
Males will be randomised as Group 1 and Group 2. In Group 1, invasive urodynamic study will be performed first in sitting then repeated in standing position. In Group 2, invasive urodynamic study will be performed first in standing then repeated in sitting position. Results will be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Invasive urodynamic study will be performed firstly in sitting position. Then, repeated in standing position.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Invasive urodynamic study will be performed firstly in standing position. Then, repeated in sitting position.
Intervention Type
Diagnostic Test
Intervention Name(s)
Invasive Urodynamic Study
Intervention Description
Invasive Urodynamic Study (Filling cystometry and pressure-flow study) Under sterile conditions and at lithotomy position, an urethral and a rectal catheter will be inserted. Bladder will be filled by sterile saline slowly. The first feeling of urine, the first sensation of urination and the sensation of severe desire to urinate will be recorded step by step. Vesical, rectal and detrusor pressures will be monitorized during these period. After the strong desire to void sensation, filling cystometry phase will be completed. Sterile saline infusion is stopped.
While the patient urinates the vesical, detrusor and rectal pressures, the maximum and average urine flow rates will be recorded.
Primary Outcome Measure Information:
Title
Invasive urodynamic study
Description
Sitting position
Time Frame
1 day
Title
Invasive urodynamic study
Description
Standing position
Time Frame
1 day
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males over 18 years old and capable of standing during test
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males over 18 years old and capable of standing during test
Exclusion Criteria:
Patients not able to stand up during the test
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tufan Tarcan, Prof
Phone
905434948365
Email
bilgi@tufantarcan.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ersin Köseoğlu
Phone
905306930442
Email
ersinkoseoglu@ku.edu.tr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Position and Invasive Urodynamic Study Results in Males
We'll reach out to this number within 24 hrs