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

ConditionUrethral Stricture

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexMale

Age18-80

SponsorAnkara City Hospital Bilkent

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population consists of 60 male participants, aged 18 to 80 years, recruited from the Urology Outpatient Clinic at Ankara Bilkent City Hospital. The population is divided into two distinct groups: a Stricture Group (n=30) comprising patients with suspected urethral stricture whose diagnosis is confirmed intraoperatively during scheduled surgery, and a Control Group (n=30) comprising healthy male volunteers with a similar age distribution and no lower urinary tract symptoms. Participants are selected based on their clinical presentation and willingness to undergo a specialized two-stage uroflowmetry protocol.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Stricture Group1 intervention

Group B: Control Group1 intervention

Trial outcomes

Primary outcomes

Urethral Resistive Index (URI)

A novel non-invasive uroflowmetric parameter calculated to assess the resistance of the urethra during voiding. It is derived using the formula: URI=Qmax,natural/Qmax,forced.

Time frame

At the time of the uroflowmetry procedure (Baseline)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara City Hospital Bilkent

Lead sponsor

Source ClinicalTrials.gov

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