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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07306767
Enrollment
130
Registered
2025-12-29
Start date
2024-12-30
Completion date
2025-09-30
Last updated
2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DIAGNOSTIC_TESTTransabdominal 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.

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.

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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in International Prostate Symptom ScoreBaseline and 6 monthsThe 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

MeasureTime frameDescription
Change in maximum urinary flow rateBaseline and 6 monthsChange in maximum urinary flow rate measured by uroflowmetry between baseline and 6 months.
Change in post-void residual urine volumeBaseline and 6 monthsChange in post-void residual urine volume measured by transabdominal ultrasonography between baseline and 6 months.
Change in detrusor wall thicknessBaseline and 6 monthsChange in detrusor wall thickness measured by transabdominal ultrasonography between baseline and 6 months.
Need for escalation of management during follow-upUp to 6 monthsProportion 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.
Change in quality of life scoreBaseline and 6 monthsChange in the quality of life index associated with the International Prostate Symptom Score between baseline and 6 months.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026