Patient Position and Invasive Urodynamic Study Results in Males
Will Performing Invasive Urodynamic Study in Sitting or Standing Position Effect the Results in Males?
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2023
CompletedFirst Posted
Study publicly available on registry
July 17, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJuly 17, 2023
July 1, 2023
2 years
July 9, 2023
July 9, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Invasive urodynamic study
Sitting position
1 day
Invasive urodynamic study
Standing position
1 day
Study Arms (2)
Group 1
ACTIVE COMPARATORInvasive urodynamic study will be performed firstly in sitting position. Then, repeated in standing position.
Group 2
ACTIVE COMPARATORInvasive urodynamic study will be performed firstly in standing position. Then, repeated in sitting position.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Males over 18 years old and capable of standing during test
You may not qualify if:
- Patients not able to stand up during the test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Koç Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 9, 2023
First Posted
July 17, 2023
Study Start
October 1, 2023
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
July 17, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share