Urethral Resistive Index (URI): A New Uroflowmetric Parameter in the Non-Invasive Diagnosis of Urethral Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Urethral Resistive Index (URI)
研究概览
简要总结
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
详细描述
This methodological study is designed as a prospective, cross-sectional, and observational diagnostic accuracy study. The primary objective is to evaluate the clinical validity of the Urethral Resistive Index (URI), a novel non-invasive parameter, in the diagnosis of urethral stricture.
Study Population and Groups:
The study will include a total of 60 male participants aged between 18 and 80 years.
Stricture Group (n=30): Patients planned for surgery (urethroplasty or internal urethrotomy) due to suspected urethral stricture, where the presence of the stricture is confirmed intraoperatively.
Control Group (n=30): Healthy male volunteers without lower urinary tract symptoms, matched for age.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Stricture Group
Patients with suspected urethral stricture scheduled for surgery (urethroplasty or internal urethrotomy), with the diagnosis confirmed intraoperatively.
干预措施: Uroflowmetry with URI Calculation (Diagnostic Test)
Control Group
Healthy male volunteers in a similar age range as the stricture group, without any lower urinary tract symptoms.
干预措施: Uroflowmetry with URI Calculation (Diagnostic Test)
结局指标
主要结局
Urethral Resistive Index (URI)
时间窗: At the time of the uroflowmetry procedure (Baseline)
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.
次要结局
未报告次要终点
研究者
Yusuf Gökkurt
Attending Physician, Department of Urology
Ankara City Hospital Bilkent