Benign Prostatic HyperplasiaNCT07306767
Ultrasound IPP to Predict Response to Medical Therapy in LUTS/BPH
An observational study of Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Bladder Outlet Obstruction
- What is being tested?
- Transabdominal ultrasound measurement of intravesical prostatic protrusion, Alpha-adrenergic blocker and 5-alpha reductase inhibitor
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2025to 30 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Being tested
- Transabdominal ultrasound measurement of intravesical prostatic protrusion, Alpha-adrenergic blocker, 5-alpha reductase inhibitor
- 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
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal ultrasound measurement of intravesical prostatic protrusionDiagnostic 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 blockerDrug
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 inhibitorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Transabdominal ultrasound measurement of intravesical prostatic protrusion; Drug: Alpha-adrenergic blocker; Drug: 5-alpha reductase inhibitor | |
| 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. Receives: Diagnostic Test: Transabdominal ultrasound measurement of intravesical prostatic protrusion; Drug: Alpha-adrenergic blocker; Drug: 5-alpha reductase inhibitor | |
| 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. Receives: Diagnostic Test: Transabdominal ultrasound measurement of intravesical prostatic protrusion; Drug: Alpha-adrenergic blocker; Drug: 5-alpha reductase inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (5)
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.
Measured: Baseline and 6 months
Change in maximum urinary flow rate
Change in maximum urinary flow rate measured by uroflowmetry between baseline and 6 months.
Measured: 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.
Measured: Baseline and 6 months
Change in detrusor wall thickness
Change in detrusor wall thickness measured by transabdominal ultrasonography between baseline and 6 months.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start30 Dec 2025
- Primary completion30 Aug 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa mohamed esmail aboalmagd, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306767
- Sponsor's protocol ID
- FMASU MS 848/2025
- Status last verified
- Sep 2026
- First submitted
- 15 Dec 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07306767
- Acronym / sponsor ID
- FMASU MS 848/2025
- Keywords
- Intravesical prostatic protrusion, Transabdominal ultrasound, Prostate ultrasound, International Prostate Symptom Score, Quality of life, Uroflowmetry, Maximum urinary flow rate, Post-void residual urine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IPP Grade I (<5 mm) | – | Diagnostic Test: Transabdominal ultrasound measurement of intravesical prostatic protrusion, Drug: Alpha-adrenergic blocker, Drug: 5-alpha reductase inhibitorParticipants 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. |
| IPP Grade II (5-10 mm) | – | Diagnostic Test: Transabdominal ultrasound measurement of intravesical prostatic protrusion, Drug: Alpha-adrenergic blocker, Drug: 5-alpha reductase inhibitorParticipants 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. |
| IPP Grade III (>10 mm) | – | Diagnostic Test: Transabdominal ultrasound measurement of intravesical prostatic protrusion, Drug: Alpha-adrenergic blocker, Drug: 5-alpha reductase inhibitorParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transabdominal ultrasound measurement of intravesical prostatic protrusionTransabdominal 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. | Diagnostic test | IPP Grade I (<5 mm), IPP Grade II (5-10 mm), IPP Grade III (>10 mm) |
| Alpha-adrenergic blockerParticipants 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 | IPP Grade I (<5 mm), IPP Grade II (5-10 mm), IPP Grade III (>10 mm) |
| 5-alpha reductase inhibitorParticipants 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. | Drug | IPP Grade I (<5 mm), IPP Grade II (5-10 mm), IPP Grade III (>10 mm) |
Primary outcome
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. 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.
5 secondary outcomes
Change in quality of life score
Time frame: Baseline and 6 months
Change in maximum urinary flow rate
Time frame: Baseline and 6 months
Change in post-void residual urine volume
Time frame: Baseline and 6 months
Change in detrusor wall thickness
Time frame: Baseline and 6 months
Need for escalation of management during follow-up
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.