Ultrasound IPP to Predict Response to Medical Therapy in LUTS/BPH

Ain Shams University

Status: Completed

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia; Bladder Outlet Obstruction

Treatments: Diagnostic Test: Transabdominal ultrasound measurement of intravesical prostatic protrusion; Drug: 5-alpha reductase inhibitor; Drug: Alpha-adrenergic blocker

Study type: Observational

Funder types: Other

Identifiers

NCT07306767

FMASU_MS403_2025

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 35.
• 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.

Exclusion criteria

• 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.

Trial design

130 participants in 3 patient groups

IPP Grade I (<5 mm)

Description:

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.

Treatment:

Drug: Alpha-adrenergic blocker

Drug: 5-alpha reductase inhibitor

Diagnostic Test: Transabdominal ultrasound measurement of intravesical prostatic protrusion

IPP Grade II (5-10 mm)

Description:

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.

Treatment:

Drug: Alpha-adrenergic blocker

Drug: 5-alpha reductase inhibitor

Diagnostic Test: Transabdominal ultrasound measurement of intravesical prostatic protrusion

IPP Grade III (>10 mm)

Description:

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.

Treatment:

Drug: Alpha-adrenergic blocker

Drug: 5-alpha reductase inhibitor

Diagnostic Test: Transabdominal ultrasound measurement of intravesical prostatic protrusion