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Completed

NCT Number: NCT07306767

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Bladder Outlet Obstruction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urethral Diseases Urethral Obstruction Urinary Bladder Diseases Urinary Bladder Neck Obstruction Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11511, Egypt

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transabdominal ultrasound measurement of intravesical prostatic protrusion

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

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

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.

Primary outcomes

  1. Change in International Prostate Symptom Score

    Time frame: 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.

Secondary outcomes

  1. Change in quality of life score

    Time frame: Baseline and 6 months

    Change in the quality of life index associated with the International Prostate Symptom Score between baseline and 6 months.

  2. Change in maximum urinary flow rate

    Time frame: Baseline and 6 months

    Change in maximum urinary flow rate measured by uroflowmetry between baseline and 6 months.

  3. Change in post-void residual urine volume

    Time frame: Baseline and 6 months

    Change in post-void residual urine volume measured by transabdominal ultrasonography between baseline and 6 months.

  4. Change in detrusor wall thickness

    Time frame: Baseline and 6 months

    Change in detrusor wall thickness measured by transabdominal ultrasonography between baseline and 6 months.

  5. Need for escalation of management during follow-up

    Time frame: Up to 6 months

    Proportion of participants who required escalation of management during follow-up (for example, change or intensification of medical therapy or referral for surgical management) due to persistent symptoms or poor objective improvement.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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