NCT07306767

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Benign Prostatic Hyperplasia
• Lower Urinary Tract Symptoms
• Bladder Outlet Obstruction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transabdominal ultrasound measurement of intravesical prostatic protrusion	Transabdominal ultrasonography; TAUS; Ultrasound IPP measurement Intervention Description: Intravesical prostatic protrusion was measured using transabdominal ultrasonography in the midsagittal plane at a bladder volume of approximately 100-200 millilitres. The measurement was defined as the distance (millimetres) from the bladder neck to the tip of the protruding prostatic tissue, and participants were categorized into Grade I (\<5 millimetres), Grade II (5-10 millimetres), or Grade III (\>10 millimetres). Ultrasound assessment was performed at baseline and during follow-up per protocol.
DRUG	Alpha-adrenergic blocker	Participants received an alpha-adrenergic blocker as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up.
DRUG	5-alpha reductase inhibitor	Participants received a 5-alpha reductase inhibitor as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up.

Timeline

• Start date: 2024-12-30
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: Egypt