Patient Position and Invasive Urodynamic Study Results in Males

Study Overview
=================
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.

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

Conditions
-----------------
Lower Urinary Tract Symptoms, Diagnosis

Intervention / Treatment
-----------------
* Diagnostic Test: Invasive Urodynamic Study


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Invasive urodynamic study will be performed firstly in sitting position. Then, repeated in standing position. | Diagnostic Test: Invasive Urodynamic Study<br>* 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.<br>|
| Active Comparator: Group 2<br>Invasive urodynamic study will be performed firstly in standing position. Then, repeated in sitting position. | Diagnostic Test: Invasive Urodynamic Study<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasive urodynamic study | Sitting position | 1 day | 
| Invasive urodynamic study | Standing position | 1 day |