Role of Ultrasound Estimation of Intra-Vesical Prostatic Protrusion in Predicting the Response to Medical Therapy in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change in International Prostate Symptom Score
概览
简要总结
This prospective cohort study evaluated whether transabdominal ultrasound measurement of intravesical prostatic protrusion predicts symptom severity and response to medical therapy in men aged 50 years or older with lower urinary tract symptoms secondary to benign prostatic hyperplasia. At baseline, participants underwent clinical evaluation, laboratory assessment including prostate-specific antigen, symptom scoring using the International Prostate Symptom Score and quality of life index, uroflowmetry, and transabdominal ultrasonography to measure prostate volume, bladder parameters, post-void residual urine, detrusor wall thickness, and intravesical prostatic protrusion. Participants were grouped by intravesical prostatic protrusion grade (less than 5 millimetres, 5 to 10 millimetres, and greater than 10 millimetres) and were followed for six months with reassessments at three and six months to evaluate response to medical therapy and identify patients who required escalation of treatment or surgical intervention.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male participants aged 50 years or older.
- •Lower urinary tract symptoms secondary to benign prostatic hyperplasia.
- •Moderate to severe symptoms with International Prostate Symptom Score 15 to
- •Prostate volume 30 to 100 millilitres.
- •Maximum urinary flow rate less than 15 millilitres per second.
- •No hydronephrosis due to bladder outlet obstruction.
- •Normal prostate-specific antigen or normal free-to-total prostate-specific antigen ratio.
排除标准
- •History of prostate, bladder, or lower urinary tract surgery.
- •Neurological disease affecting lower urinary tract function.
- •Active urinary tract infection and/or symptomatic urinary tract stones.
- •Post-void residual urine volume greater than 200 millilitres.
- •Urethral stricture.
- •Prostate cancer or bladder cancer.
研究组 & 干预措施
IPP Grade I (<5 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion less than 5 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters.
干预措施: Transabdominal ultrasound measurement of intravesical prostatic protrusion (Diagnostic Test)
IPP Grade I (<5 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion less than 5 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters.
干预措施: Alpha-adrenergic blocker (Drug)
IPP Grade I (<5 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion less than 5 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters.
干预措施: 5-alpha reductase inhibitor (Drug)
IPP Grade II (5-10 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion 5 to 10 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters.
干预措施: Transabdominal ultrasound measurement of intravesical prostatic protrusion (Diagnostic Test)
IPP Grade II (5-10 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion 5 to 10 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters.
干预措施: Alpha-adrenergic blocker (Drug)
IPP Grade II (5-10 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion 5 to 10 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters.
干预措施: 5-alpha reductase inhibitor (Drug)
IPP Grade III (>10 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion greater than 10 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters.
干预措施: Transabdominal ultrasound measurement of intravesical prostatic protrusion (Diagnostic Test)
IPP Grade III (>10 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion greater than 10 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters.
干预措施: Alpha-adrenergic blocker (Drug)
IPP Grade III (>10 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion greater than 10 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters.
干预措施: 5-alpha reductase inhibitor (Drug)
结局指标
主要结局
Change in International Prostate Symptom Score
时间窗: Baseline and 6 months
The International Prostate Symptom Score was used to quantify lower urinary tract symptom severity. The outcome was the change in total score between baseline (pre-treatment) and the 6-month follow-up visit.
次要结局
- Change in quality of life score(Baseline and 6 months)
- Change in maximum urinary flow rate(Baseline and 6 months)
- Change in post-void residual urine volume(Baseline and 6 months)
- Change in detrusor wall thickness(Baseline and 6 months)
- Need for escalation of management during follow-up(Up to 6 months)
研究者
Mustafa mohamed esmail aboalmagd
Resident of Urology
Ain Shams University