Prostatic HyperplasiaNCT07749794
Hydrodissection-Assisted Bipolar Prostatic Enucleation Versus Conventional Bipolar Enucleation
A study testing Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection and Conventional Bipolar Prostatic Enucleation-Enucleoresection in people with Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Benha University at 1 site in Egypt.
Trial summary
This prospective randomized study will compare two surgical techniques for treating benign prostatic hyperplasia. Participants will be assigned to either hydrodissection-assisted bipolar prostatic enucleation-enucleoresection with transrectal ultrasound-guided subcapsular injection of diluted norepinephrine and… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection and Conventional Bipolar Prostatic Enucleation-Enucleoresection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2026to 15 Aug 2027
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign prostatic hyperplasia.
- Prostate volume greater than 60 cc as measured by transrectal ultrasonography.
- Moderate-to-severe lower urinary tract symptoms, defined as an International Prostate - Symptom Score of 12 or higher.
- Failure of or poor response to medical management.
Who cannot join
- History of prostate cancer or suspicious findings on prostate biopsy.
- Active urinary tract infection.
- Severe cardiovascular, pulmonary, or other systemic comorbidities that contraindicate surgery.
- Previous prostate surgery, including transurethral resection of the prostate or open prostatectomy.
- Chronic urinary retention associated with neurogenic bladder. Hypersensitivity to norepinephrine or methylene blue.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Benha University Hospital
Banhā, Qalyubia Governorate, 13511
Saad A Salama, MD, 01063006039 ext. +2, saad.ali@fmed.bu.edu.eg
About this study
Official title: Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection With Subcapsular Injection of Diluted Norepinephrine-Methylene Blue Mixture Versus Conventional Bipolar Prostatic Enucleation-Enucleoresection: A Prospective Randomized Comparative Study
This prospective randomized study will compare two surgical techniques for treating benign prostatic hyperplasia. Participants will be assigned to either hydrodissection-assisted bipolar prostatic enucleation-enucleoresection with transrectal ultrasound-guided subcapsular injection of diluted norepinephrine and methylene blue or conventional bipolar prostatic enucleation-enucleoresection without injection.
The injected mixture is intended to separate the enlarged prostatic tissue from the surgical capsule and reduce bleeding during surgery. The study will evaluate whether the hydrodissection-assisted technique improves operative conditions, surgical outcomes, postoperative recovery, urinary symptoms, and urinary flow compared with the conventional technique.
- Being tested
- Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection, Conventional Bipolar Prostatic Enucleation-Enucleoresection
- Keywords
- Bipolar prostatic enucleation, Hydrodissection, Subcapsular prostatic injection, Norepinephrine, Methylene blue
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrodissection-Assisted Bipolar Prostatic Enucleation-EnucleoresectionProcedure or surgery
Transrectal ultrasound-guided subcapsular injection will be used to create a hydrodissection plane between the prostatic adenoma and capsule before bipolar enucleation-enucleoresection.
Conventional Bipolar Prostatic Enucleation-EnucleoresectionProcedure or surgery
Participants will undergo conventional bipolar prostatic enucleation-enucleoresection without subcapsular injection or hydrodissection.
| Study group | Role | What they receive |
|---|---|---|
| Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection | Experimental | Participants will undergo transrectal ultrasound-guided subcapsular injection of a diluted norepinephrine-methylene blue mixture to produce hydrodissection between the prostatic adenoma and surgical capsule, followed by bipolar prostatic enucleation-enucleoresection. Standard postoperative bladder irrigation, catheter management, and follow-up will be provided. Receives: Procedure: Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection |
| Conventional Bipolar Prostatic Enucleation-Enucleoresection | Active comparator | Participants will undergo conventional bipolar prostatic enucleation-enucleoresection without subcapsular injection or hydrodissection. Standard postoperative bladder irrigation, catheter management, and follow-up will be provided. Receives: Procedure: Conventional Bipolar Prostatic Enucleation-Enucleoresection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Blood Loss
The estimated volume of blood lost during the operative procedure will be recorded in milliliters and compared between the hydrodissection-assisted and conventional groups.
Measured: Intraoperatively
Secondary outcomes (9)
Operative Time
Operative time will be measured in minutes from insertion of the resectoscope until completion of urethral catheter placement.
Measured: Intraoperatively
Enucleated Prostatic Tissue Weight
The removed prostatic adenomatous tissue will be weighed in grams.
Measured: Immediately after tissue retrieval, intraoperatively
Length of Hospital Stay
The duration of hospitalization will be measured in hours from completion of surgery until hospital discharge.
Measured: From completion of surgery until hospital discharge, assessed up to 7 days
Urethral Catheterization Duration
The duration of postoperative urethral catheterization will be measured in hours from catheter placement at the end of surgery until catheter removal.
Measured: From completion of surgery until catheter removal, assessed up to 7 days
Change in Maximum Urinary Flow Rate
Maximum urinary flow rate will be measured by uroflowmetry in mL/second. Values obtained after surgery will be compared with the preoperative baseline value.
Measured: At baseline and at 1, 3, and 6 months after surgery
Change in Post-Void Residual Urine Volume
Post-void residual urine volume will be measured by ultrasonography in milliliters. Values obtained after surgery will be compared with the preoperative baseline value.
Measured: At baseline and at 1, 3, and 6 months after surgery
Change in International Prostate Symptom Score
Lower urinary tract symptoms will be assessed using the International Prostate Symptom Score, ranging from 0 to 35, with higher scores indicating more severe symptoms. Postoperative scores will be compared with the preoperative baseline score.
Measured: At baseline and at 1, 3, and 6 months after surgery
Incidence of Postoperative Complications
The proportion of participants experiencing postoperative complications will be recorded.
Measured: At 1, 3, and 6 months after surgery
Incidence of Intraoperative Complications
The proportion of participants experiencing intraoperative complications will be recorded.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned in parallel to undergo either hydrodissection-assisted bipolar prostatic enucleation-enucleoresection with transrectal ultrasound-guided subcapsular injection of diluted norepinephrine-methylene blue mixture or conventional bipolar prostatic enucleation-enucleoresection without hydrodissection or injection.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saad ali saad salama, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749794
- Sponsor's protocol ID
- RC.8.1.2026
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection With Subcapsular Injection of Diluted Norepinephrine-Methylene Blue Mixture Versus Conventional Bipolar Prostatic Enucleation-Enucleoresection: A Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07749794
- Acronym / sponsor ID
- RC.8.1.2026
- Keywords
- Bipolar prostatic enucleation, Hydrodissection, Subcapsular prostatic injection, Norepinephrine, Methylene blue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 6 Aug 2026 (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 randomized study will compare two surgical techniques for treating benign prostatic hyperplasia. Participants will be assigned to either hydrodissection-assisted bipolar prostatic enucleation-enucleoresection with transrectal ultrasound-guided subcapsular injection of diluted norepinephrine and methylene blue or conventional bipolar prostatic enucleation-enucleoresection without injection.
The injected mixture is intended to separate the enlarged prostatic tissue from the surgical capsule and reduce bleeding during surgery. The study will evaluate whether the hydrodissection-assisted technique improves operative conditions, surgical outcomes, postoperative recovery, urinary symptoms, and urinary flow compared with the conventional technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in parallel to undergo either hydrodissection-assisted bipolar prostatic enucleation-enucleoresection with transrectal ultrasound-guided subcapsular injection of diluted norepinephrine-methylene blue mixture or conventional bipolar prostatic enucleation-enucleoresection without hydrodissection or injection.
| Arm | Type | Receives |
|---|---|---|
| Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection | Experimental | Procedure: Hydrodissection-Assisted Bipolar Prostatic Enucleation-EnucleoresectionParticipants will undergo transrectal ultrasound-guided subcapsular injection of a diluted norepinephrine-methylene blue mixture to produce hydrodissection between the prostatic adenoma and surgical capsule, followed by bipolar prostatic enucleation-enucleoresection. Standard postoperative bladder irrigation, catheter management, and follow-up will be provided. |
| Conventional Bipolar Prostatic Enucleation-Enucleoresection | Active comparator | Procedure: Conventional Bipolar Prostatic Enucleation-EnucleoresectionParticipants will undergo conventional bipolar prostatic enucleation-enucleoresection without subcapsular injection or hydrodissection. Standard postoperative bladder irrigation, catheter management, and follow-up will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Benign prostatic hyperplasia.
- Prostate volume greater than 60 cc as measured by transrectal ultrasonography.
- Moderate-to-severe lower urinary tract symptoms, defined as an International Prostate - Symptom Score of 12 or higher.
- Failure of or poor response to medical management.
Key exclusion criteria (5 listed)
- History of prostate cancer or suspicious findings on prostate biopsy.
- Active urinary tract infection.
- Severe cardiovascular, pulmonary, or other systemic comorbidities that contraindicate surgery.
- Previous prostate surgery, including transurethral resection of the prostate or open prostatectomy.
- Chronic urinary retention associated with neurogenic bladder. Hypersensitivity to norepinephrine or methylene blue.
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 |
|---|---|---|
| Hydrodissection-Assisted Bipolar Prostatic Enucleation-EnucleoresectionTransrectal ultrasound-guided subcapsular injection will be used to create a hydrodissection plane between the prostatic adenoma and capsule before bipolar enucleation-enucleoresection. | Procedure or surgery | Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection |
| Conventional Bipolar Prostatic Enucleation-EnucleoresectionParticipants will undergo conventional bipolar prostatic enucleation-enucleoresection without subcapsular injection or hydrodissection. | Procedure or surgery | Conventional Bipolar Prostatic Enucleation-Enucleoresection |
Primary outcome
Intraoperative Blood Loss
Time frame: Intraoperatively
The estimated volume of blood lost during the operative procedure will be recorded in milliliters and compared between the hydrodissection-assisted and conventional groups.
9 secondary outcomes
Operative Time
Time frame: Intraoperatively
Enucleated Prostatic Tissue Weight
Time frame: Immediately after tissue retrieval, intraoperatively
Length of Hospital Stay
Time frame: From completion of surgery until hospital discharge, assessed up to 7 days
Urethral Catheterization Duration
Time frame: From completion of surgery until catheter removal, assessed up to 7 days
Change in Maximum Urinary Flow Rate
Time frame: At baseline and at 1, 3, and 6 months after surgery
Change in Post-Void Residual Urine Volume
Time frame: At baseline and at 1, 3, and 6 months after surgery
Change in International Prostate Symptom Score
Time frame: At baseline and at 1, 3, and 6 months after surgery
Incidence of Postoperative Complications
Time frame: At 1, 3, and 6 months after surgery
Incidence of Intraoperative Complications
Time frame: Intraoperatively
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 6 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection and Conventional Bipolar Prostatic Enucleation-Enucleoresection in people with Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Benha 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 4 inclusion and 5 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 6 Aug 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?
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 Saad A Salama, MD (01063006039 ext. +2, saad.ali@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Blood Loss (time frame: Intraoperatively). 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 6 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.