BPH (Benign Prostatic Hyperplasia)NCT06922968
Real-Time (TRUS) Guidance in Endoscopic Treatment of BPH
A study testing TRUS-Guided TURP and enucleation and Standard TURP and enucleation in people with BPH (Benign Prostatic Hyperplasia), run by Assiut University at 1 site in Egypt.
Trial summary
The study aims to evaluate the role of TRUS in improving the efficacy and safety of endoscopic enucleation of prostate and TURP. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- TRUS-Guided TURP and enucleation and Standard TURP and enucleation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged 50-80 years
- Diagnosed with benign prostatic hyperplasia (BPH) and scheduled for TURP or prostatic adenoma enucleation.
- The patients have clear indication for endoscopic surgery (according to the guidelines).
- Clinically fit patients for surgery.
- Signed an informed consent.
Who cannot join
- • Prostate cancer
- Previous urethral or prostate surgery
- Neurogenic bladder
- Urethral stricture
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed mostafa Elsharkawy, assistant lecturer of Urology contact
About this study
Official title: Standard Versus Transrectal Ultrasound (TRUS)-Guided Endoscopic Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Controlled Trial
The study aims to evaluate the role of TRUS in improving the efficacy and safety of endoscopic enucleation of prostate and TURP.
Read the detailed description
Standard TURP is an established procedure for managing BPH but has limitations, including the risk of incomplete adenoma removal and complications such as bleeding. Research on transurethral enucleation techniques has demonstrated potential for improved outcomes, especially in larger prostates. However, challenges persist in achieving precise resection boundaries and minimizing intraoperative risks.
TRUS, widely utilized for prostate biopsy and volume assessment, has recently gained attention for its intraoperative applications. Studies show that real-time TRUS provides accurate imaging of prostate anatomy and resection planes, helping surgeons better differentiate adenomatous tissue from surrounding structures. This enhances surgical precision, reduces intraoperative bleeding, and minimizes residual tissue, leading to better outcomes in procedures like TURP and enucleation.
Current TURP and enucleation approaches depend heavily on endoscopic visual guidance, which, despite significant advancements, can lead to residual tissue, excessive bleeding, and prolonged recovery. While enucleation techniques have addressed some of these challenges, they remain less accessible due to high costs and steep learning curves, making them unsuitable for all healthcare settings.
Integrating TRUS into TURP or enucleation offers the potential to address these limitations by enhancing tissue differentiation and guiding precise resection. This study aims to evaluate the efficacy of TRUS in reducing complications, achieving complete tissue removal, and improving patient recovery outcomes, potentially paving the way for its routine adoption in BPH surgery.
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Being tested
- TRUS-Guided TURP and enucleation, Standard TURP and enucleation
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUS-Guided TURP and enucleationProcedure or surgery
realtime TRUS guidance during the procedure (TURP and enucleation)
Standard TURP and enucleationProcedure or surgery
No TRUS guidance during the procedure (TURP and enucleation)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Control cases under went TURP and enucleation Receives: Procedure: Standard TURP and enucleation |
| TRUS Guided group | Experimental | TRUS guided group during TURP and enucleation Receives: Procedure: TRUS-Guided TURP and enucleation |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of endoscopic treatment of BPH
Intervention efficacy will be evaluated by comparing the Peak flow rate in ml/second.(measured by uroflowmetry) between the two groups
Measured: At 12 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed ElSharkawy, Assiut University
- Investigators
- Ahmed Mohamed Abdel-Moniem Hassanein, professor of Urology, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922968
- Sponsor's protocol ID
- TRUS with TURP and enucleation
- Status last verified
- Apr 2025
- First submitted
- 17 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to put protect privacy of participants
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus Transrectal Ultrasound (TRUS)-Guided Endoscopic Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06922968
- Acronym / sponsor ID
- TRUS with TURP and enucleation
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 11 Apr 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.
The study aims to evaluate the role of TRUS in improving the efficacy and safety of endoscopic enucleation of prostate and TURP.
Detailed description
Standard TURP is an established procedure for managing BPH but has limitations, including the risk of incomplete adenoma removal and complications such as bleeding. Research on transurethral enucleation techniques has demonstrated potential for improved outcomes, especially in larger prostates. However, challenges persist in achieving precise resection boundaries and minimizing intraoperative risks.
TRUS, widely utilized for prostate biopsy and volume assessment, has recently gained attention for its intraoperative applications. Studies show that real-time TRUS provides accurate imaging of prostate anatomy and resection planes, helping surgeons better differentiate adenomatous tissue from surrounding structures. This enhances surgical precision, reduces intraoperative bleeding, and minimizes residual tissue, leading to better outcomes in procedures like TURP and enucleation.
Current TURP and enucleation approaches depend heavily on endoscopic visual guidance, which, despite significant advancements, can lead to residual tissue, excessive bleeding, and prolonged recovery. While enucleation techniques have addressed some of these challenges, they remain less accessible due to high costs and steep learning curves, making them unsuitable for all healthcare settings.
Integrating TRUS into TURP or enucleation offers the potential to address these limitations by enhancing tissue differentiation and guiding precise resection. This study aims to evaluate the efficacy of TRUS in reducing complications, achieving complete tissue removal, and improving patient recovery outcomes, potentially paving the way for its routine adoption in BPH surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Procedure: Standard TURP and enucleationControl cases under went TURP and enucleation |
| TRUS Guided group | Experimental | Procedure: TRUS-Guided TURP and enucleationTRUS guided group during TURP and enucleation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients aged 50-80 years
- Diagnosed with benign prostatic hyperplasia (BPH) and scheduled for TURP or prostatic adenoma enucleation.
- The patients have clear indication for endoscopic surgery (according to the guidelines).
- Clinically fit patients for surgery.
- Signed an informed consent.
Key exclusion criteria (4 listed)
- • Prostate cancer
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 |
|---|---|---|
| TRUS-Guided TURP and enucleationrealtime TRUS guidance during the procedure (TURP and enucleation) | Procedure or surgery | TRUS Guided group |
| Standard TURP and enucleationNo TRUS guidance during the procedure (TURP and enucleation) | Procedure or surgery | Control group |
Primary outcome
efficacy of endoscopic treatment of BPH
Time frame: At 12 weeks after the procedure
Intervention efficacy will be evaluated by comparing the Peak flow rate in ml/second.(measured by uroflowmetry) between the two groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No. to put protect privacy of participants
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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.
Mohamed mostafa Elsharkawy, assistant lecturer of Urology contact
Ahmed Mohamed Abdel-Moniem Hassanein, professor of Urology study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRUS-Guided TURP and enucleation and Standard TURP and enucleation in people with BPH (Benign Prostatic Hyperplasia), run by Assiut 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed mostafa Elsharkawy, assistant lecturer of Urology (+201065811880, mhmdsharkawy@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of endoscopic treatment of BPH (time frame: At 12 weeks after the procedure). 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 11 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.