Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large ProstatePhase 3NCT07733167
Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate: Exploring Its Role in Optimizing Surgical Outcomes
A Phase 3 study testing TURP and Epinephrine in people with Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate, run by Benha University at 1 site in Egypt.
Trial summary
Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate: Exploring Its Role in Optimizing Surgical Outcomes Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate
- What is being tested?
- TURP and Epinephrine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2025to 20 Oct 2026
- Phase
- Phase 3
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for Prostate Surgery or Procedure - Patients undergoing transurethral resection of the prostate (TURP)
- Prostate from 80 to 100 gm
- Failed medical therapy
Who cannot join
- Uncontrolled Hypertension - Patients with significantly high blood pressure despite medication therapy.
- Unstable angina, recent myocardial infarction, arrhythmias, or severe heart failure.
- Significant Coagulopathy - Patients with bleeding disorders or on anticoagulants where excessive vasoconstriction may lead to tissue necrosis or inadequate perfusion
- Hyperthyroidism, Pheochromocytoma or Endocrine Disorders - Patients with catecholamine-secreting tumors or other conditions that can lead to excessive sympathetic stimulation.
- Treatment in the last 3 months with 5-alpha reductase inhibitors.
- Genitourinary cancer, urinary tract lithiasis, and urological surgery within the last 3 months
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, 1 recruiting
- Recruiting
Ahmed Abdelraouf Saad
Banhā, Qalyubia Governorate
Ahmed abdelraouf, +2001070770797, ahmedouufaa20@gmail.com
About this study
Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate: Exploring Its Role in Optimizing Surgical Outcomes
- Conditions
- Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate
- Being tested
- TURP, Epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURPDevice
Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate
EpinephrineDrug
Intra-Prostatic epinephrine injection in Bipolar Transurethral resection of large prostate
| Study group | Role | What they receive |
|---|---|---|
| Epinephrine injection | Active comparator | Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate Receives: Device: TURP; Drug: Epinephrine |
| saline injection | Placebo comparator | Not described Receives: Device: TURP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss , need of blood transfusion
assessment of Blood Loss (Irrigation Fluid Hb Concentration):
Bladder irrigation will be maintained for 24 hours post operatively, with fluid collections made at three intervals:
Immediately postsurgery (V1), 6 hours postoperation (V2), and 24 hours postoperation (V3). The total volume collected will be measured, and 5000U of heparin will be added to each irrigation fluid container to prevent coagulation. After thorough mixing, 5-mL samples will be extracted and analyzed using cyanide met hemoglobin spectrophotometry at 540 nm to determine the Hb concentration. Blood loss will be estimated using specific formulas: (1) Hb concentration in irrigation fluid (g/L) = absorbance of fluid × 367.7; (2) Bleeding volume (mL) = (Hb concentration in irrigation fluid (g/L) × rinse volume (mL)) / preoperative Hb concentration(g/L).
Measured: 24h post operative
Secondary outcomes (1)
Prostate volume , post voiding residual urine
prostate volume \& post voiding residual urine will be measured by Transrectal ultrasound
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start20 Mar 2025
- Primary completion20 Mar 2026
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large ProstateStudies of the same condition, open and under way.
- More trials run by Benha 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelraouf Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733167
- Sponsor's protocol ID
- ms 20-3-2025
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate: Exploring Its Role in Optimizing Surgical Outcomes
- ClinicalTrials.gov ID
- NCT07733167
- Acronym / sponsor ID
- ms 20-3-2025
- Conditions
- Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 29 Jul 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.
Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate: Exploring Its Role in Optimizing Surgical Outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinephrine injection | Active comparator | Device: TURP, Drug: EpinephrineIntra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate |
| saline injection | Placebo comparator | Device: TURP |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for Prostate Surgery or Procedure - Patients undergoing transurethral resection of the prostate (TURP)
- Prostate from 80 to 100 gm
- Failed medical therapy
Key exclusion criteria (6 listed)
- Uncontrolled Hypertension - Patients with significantly high blood pressure despite medication therapy.
- Unstable angina, recent myocardial infarction, arrhythmias, or severe heart failure.
- Significant Coagulopathy - Patients with bleeding disorders or on anticoagulants where excessive vasoconstriction may lead to tissue necrosis or inadequate perfusion
- Hyperthyroidism, Pheochromocytoma or Endocrine Disorders - Patients with catecholamine-secreting tumors or other conditions that can lead to excessive sympathetic stimulation.
- Treatment in the last 3 months with 5-alpha reductase inhibitors.
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 |
|---|---|---|
| TURPIntra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate | Device | Epinephrine injection, saline injection |
| EpinephrineIntra-Prostatic epinephrine injection in Bipolar Transurethral resection of large prostate | Drug | Epinephrine injection |
Primary outcome
Intraoperative blood loss , need of blood transfusion
Time frame: 24h post operative
assessment of Blood Loss (Irrigation Fluid Hb Concentration): Bladder irrigation will be maintained for 24 hours post operatively, with fluid collections made at three intervals: Immediately postsurgery (V1), 6 hours postoperation (V2), and 24 hours postoperation (V3). The total volume collected will be measured, and 5000U of heparin will be added to each irrigation fluid container to prevent coagulation. After thorough mixing, 5-mL samples will be extracted and analyzed using cyanide met hemoglobin spectrophotometry at 540 nm to determine the Hb concentration. Blood loss will be estimated using specific formulas: (1) Hb concentration in irrigation fluid (g/L) = absorbance of fluid × 367.7; (2) Bleeding volume (mL) = (Hb concentration in irrigation fluid (g/L) × rinse volume (mL)) / preoperative Hb concentration(g/L).
1 secondary outcome
Prostate volume , post voiding residual urine
Time frame: 3 months
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 29 Jul 2026.
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 Phase 3 study testing TURP and Epinephrine in people with Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate, 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 3 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: looking for participants now, as of the sponsor's last update on 29 Jul 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss , need of blood transfusion (time frame: 24h post operative). 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 29 Jul 2026.