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NCT05947565 Clinical Trial

Patient Position and Invasive Urodynamic Study Results in Males

Lower Urinary Tract Symptoms Clinical Trial

Official title:
Will Performing Invasive Urodynamic Study in Sitting or Standing Position Effect the Results in Males?

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05947565
Other study ID # KocUrol4
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date October 1, 2025

Study information
Verified date July 2023
Source Koç University
Contact Tufan Tarcan, Prof
Phone 905434948365
Email bilgi@tufantarcan.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date October 1, 2025
Est. primary completion date October 1, 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Males over 18 years old and capable of standing during test Exclusion Criteria: - Patients not able to stand up during the test

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Invasive Urodynamic Study
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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Koç University

Outcome
Type Measure Description Time frame Safety issue
Primary Invasive urodynamic study Sitting position 1 day
Primary Invasive urodynamic study Standing position 1 day
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