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

NCT ID: NCT07306767

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2025-09-30

Brief 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

Keywords

Intravesical prostatic protrusion; Transabdominal ultrasound; Prostate ultrasound; International Prostate Symptom Score; Quality of life; Uroflowmetry; Maximum urinary flow rate; Post-void residual urine; Detrusor wall thickness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Transabdominal ultrasound measurement of intravesical prostatic protrusion

Intervention Type: DIAGNOSTIC_TEST

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.

Alpha-adrenergic blocker

Intervention Type: DRUG

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.

5-alpha reductase inhibitor

Intervention Type: DRUG

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.

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.

Transabdominal ultrasound measurement of intravesical prostatic protrusion

Intervention Type: DIAGNOSTIC_TEST

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.

Alpha-adrenergic blocker

Intervention Type: DRUG

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.

5-alpha reductase inhibitor

Intervention Type: DRUG

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.

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.

Transabdominal ultrasound measurement of intravesical prostatic protrusion

Intervention Type: DIAGNOSTIC_TEST

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.

Alpha-adrenergic blocker

Intervention Type: DRUG

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.

5-alpha reductase inhibitor

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mustafa mohamed esmail aboalmagd

Resident of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Hospitals

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

FMASU_MS403_2025

Identifier Type: -

Identifier Source: org_study_id