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Recruiting NCT07403786

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

Conditions: Urethral Stricture

Sex: Male
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Enrollment: 60
Sponsor: Ankara City Hospital Bilkent

Location: Ankara Bilkent City Hospital Ankara Universiteler

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07403786). StuddyBuddy aggregates publicly available trial information.