An observational study in Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms and Bladder Outlet Obstruction, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Ain Shams University · Observational
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's enrollment of 130 is below the median of 250 across 177 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men aged 50 years or older with moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia attending urology outpatient services at Ain Shams University Hospitals.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Diagnostic Test: Transabdominal ultrasound measurement of intravesical prostatic protrusion · Drug: Alpha-adrenergic blocker · Drug: 5-alpha reductase inhibitor
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.
Diagnostic Test: Transabdominal ultrasound measurement of intravesical prostatic protrusion · Drug: Alpha-adrenergic blocker · Drug: 5-alpha reductase inhibitor
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.
Diagnostic Test: Transabdominal ultrasound measurement of intravesical prostatic protrusion · Drug: Alpha-adrenergic blocker · Drug: 5-alpha reductase inhibitor
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.
Change in International Prostate Symptom Score
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. The International Prostate Symptom Score (IPSS) is a seven-item questionnaire assessing lower urinary tract symptom severity. Each item is scored from 0 to 5, giving a total score ranging from 0 to 35, with higher scores indicating more severe symptoms. The outcome was the change in total IPSS from baseline to the 6-month follow-up visit.
Time frame: Baseline and 6 months
Change in quality of life score
Change in the quality of life index associated with the Intenational Prostate Symptom Score between baseline and 6 months. The International Prostate Symptom Score quality-of-life (IPSS-QoL) question is a single item scored from 0 to 6, where 0 indicates the best quality of life and 6 indicates the worst quality of life related to urinary symptoms. Higher scores indicate worse quality of life. The outcome was the change in IPSS-QoL score from baseline to the 6-month follow-up visit.
Time frame: Baseline and 6 months
Change in maximum urinary flow rate
Change in maximum urinary flow rate measured by uroflowmetry between baseline and 6 months.
Time frame: Baseline and 6 months
Change in post-void residual urine volume
Change in post-void residual urine volume measured by transabdominal ultrasonography between baseline and 6 months.
Time frame: Baseline and 6 months
Change in detrusor wall thickness
Change in detrusor wall thickness measured by transabdominal ultrasonography between baseline and 6 months.
Time frame: Baseline and 6 months
Need for escalation of management during follow-up
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.
Time frame: Up to 6 months
Plan to share: Yes — De-identified individual participant data collected during the study will be shared, including baseline and follow-up measurements (International Prostate Symptom Score and quality of life index, uroflowmetry parameters, transabdominal ultrasound parameters including intravesical prostatic protrusion, prostate volume, post-void residual urine, and detrusor wall thickness), along with a data dictionary. Direct identifiers will be removed and data will be coded prior to sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: De-identified data will be available beginning 6 months after study completion and will remain available for 5 years.
Access criteria: Data will be shared with qualified researchers upon reasonable request and after review and approval by the study investigators and the institutional administration. Requesters must submit a proposal outlining objectives and planned analyses and must sign a data use agreement that prohibits re-identification and limits use to the approved purpose.
No publications or documents are linked to this record.
Ran from Dec 2025 to primary completion in Aug 2026, 8 months.
Of 59 non-industry observational studies under Prostatic Hyperplasia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 50. This study's 8 months is below that.
Counting every sponsor, half of 74 studies reached it within 25 months; a quarter within 12 and three quarters within 50.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: start Dec 2024 → Dec 2025, primary completion Sep 2025 → Aug 2026 and completion Sep 2025 → Aug 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.