Patient Position and Invasive Urodynamic Study Results in Males

Sponsor

Koç University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05947565

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptoms Diagnosis	Diagnostic Test: Invasive Urodynamic Study	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 Invasive urodynamic study will be performed firstly in sitting position. Then, repeated in standing position.	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.
Active Comparator: Group 2 Invasive urodynamic study will be performed firstly in standing position. Then, repeated in sitting position.	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.

Arm

Intervention/Treatment

Active Comparator: Group 1

Invasive urodynamic study will be performed firstly in sitting position. Then, repeated in standing position.

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.

Active Comparator: Group 2

Invasive urodynamic study will be performed firstly in standing position. Then, repeated in sitting position.

Diagnostic Test: Invasive Urodynamic Study

Outcome Measures

Primary Outcome Measures

Invasive urodynamic study [1 day]
Sitting position
Invasive urodynamic study [1 day]
Standing position

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Koç University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ersin Köseoglu, MD, Koç University

ClinicalTrials.gov Identifier:

NCT05947565

Other Study ID Numbers:

KocUrol4

First Posted:

Jul 17, 2023

Last Update Posted:

Jul 17, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lower Urinary Tract Symptoms

Study Results

No Results Posted as of Jul 17, 2023