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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
Koç University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lower Urinary Tract Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    July 9, 2023
    Last Updated
    July 9, 2023
    Sponsor
    Koç University
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    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

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