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Clinical Trials in Turkey / NCT07403786
Recruiting Observational

Urethral Resistive Index (URI): A New Parameter for Diagnosing Urethral Obstruction

NCT07403786 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-02-10
Last updated
2026-04-06

Condition(s) studied

Urethral Stricture

Investigational drug(s) / intervention(s)

Uroflowmetry with URI Calculation

Uroflowmetry with URI Calculation: Performing natural and forced (Valsalva) uroflowmetry sessions to calculate the Urethral Resistive Index.

Study summary

This prospective observational study aims to evaluate the diagnostic accuracy of a new, non-invasive uroflowmetry parameter called the Urethral Resistive Index (URI) for detecting urethral stricture in men. Currently, diagnosing urethral stricture often requires invasive procedures like surgery or pressure-flow studies. This research seeks to develop URI as a practical and painless screening tool that could reduce the need for such invasive interventions.

Study Procedures:

A total of 60 male participants (30 with suspected urethral stricture and 30 healthy volunteers) will be enrolled. Participants will undergo two standard, non-invasive uroflowmetry (voiding) tests. The first test is a routine natural voiding session. The second test involves a "forced voiding" (Valsalva maneuver) once the participant feels a sufficient urge to urinate again. The URI is then calculated by comparing the flow rates of these two sessions.

Goals and Benefits: The primary goal is to determine the optimal "cut-off" value of the URI that accurately identifies a surgically proven urethral stricture. By demonstrating URI's effectiveness, the study aims to expedite the diagnostic process and spare patients from unnecessary invasive tests. The procedure involves minimal risk, primarily temporary discomfort or psychological stress during the voiding tests

Eligibility

Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Male participants aged between 18 and 80 years. * For the Stricture Group: Patients scheduled for surgery (urethroplasty or internal urethrotomy) due to suspected urethral stricture, where the diagnosis is confirmed intraoperatively. * For the Control Group: Healthy male volunteers without any lower urinary tract symptoms. * Voluntary signing of the Informed Consent Form. Exclusion Criteria: * Voiding volume less than 150 mL. * Causes of obstruction other than stricture, such as Benign Prostatic Hyperplasia (BPH). * Diagnosis of neurogenic bladder dysfunction or a history of neurological disease affecting bladder function. * Presence of severe comorbidities.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ankara Bilkent City Hospital Ankara Universiteler Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07403786 on ClinicalTrials.gov ↗ ← All trials in Turkey