Patient Position and Invasive Urodynamic Study Results in Males

NCT ID: NCT05947565

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-10-01

Brief Summary

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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

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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.

Conditions

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Lower Urinary Tract Symptoms Diagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type ACTIVE_COMPARATOR

Invasive Urodynamic Study

Intervention Type DIAGNOSTIC_TEST

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.

Group 2

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

Group Type ACTIVE_COMPARATOR

Invasive Urodynamic Study

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Males over 18 years old and capable of standing during test

Exclusion Criteria

* Patients not able to stand up during the test
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Koç University

OTHER

Sponsor Role lead

Responsible Party

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Ersin Köseoglu

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Tufan Tarcan, Prof

Role: CONTACT

905434948365

Ersin Köseoğlu

Role: CONTACT

905306930442

Other Identifiers

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KocUrol4

Identifier Type: -

Identifier Source: org_study_id

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