Benign Prostatic HyperplasiaNCT05913466
Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP
A study testing Tranexamic Acid group and Distilled water group in people with Benign Prostatic Hyperplasia and Transurethral Resection of the Prostate, run by Benha University.
Trial summary
This study aims to assess the role of intraprostatic injection of tranexamic acid in decreasing the blood loss during Transurethral resection of the prostate. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate, Tranexamic Acid
- What is being tested?
- Tranexamic Acid group and Distilled water group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2023to 20 Jun 2024
- Phase
- Interventional
- 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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with an age between 50 and 85 years old
- who had benign prostatic hyperplasia (aged 50-85 years) with a prostate weight of 50-80 g.
- undergoing Transurethral resection of the prostate
Who cannot join
- Patient refusal.
- Patients hypersensitive to Tranexamic Acid, or on antiplatelet and anticoagulant drugs.
- Patients with a history of thrombotic events, bleeding disorders, chronic kidney disease.
- Patients with abnormal liver function test.
- Patients with cardiovascular disease and receiving with a drug-eluting stent, bladder stone, urethral stricture, or with previous prostate surgery, prostate cancer, with a UTI or who receiving 5α-reductase inhibitors.
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to assess the role of intraprostatic injection of tranexamic acid in decreasing the blood loss during Transurethral resection of the prostate.
Read the detailed description
Benign prostatic hyperplasia (BPH) is a process in which the pathology results in increased number of both stromal and epithelial cells in the area of the prostate around the urethra, which is pathologically known as hyperplasia, and not hypertrophy.
The accurate cause is not well known; however, "reactivation" of embryonic processes is one of the hypotheses that may cause benign prostatic hyperplasia (BPH). Benign prostatic hyperplasia (BPH) is a common condition that affects elderly men. Recently, many noninvasive and mini-invasive modalities have become popular for the management of men with voiding symptoms.
Transurethral resection of the prostate (TURP) is one of the most common and well-developed techniques used to treat benign prostatic hyperplasia (BPH), recognized as the 'gold standard' of the surgical treatments of enlarged prostates. The most relevant complications are the inability to void (5.8%), surgical revision (5.6%), urinary tract infection (UTI) (3.6%), bleeding requiring transfusions (2.9%), and Transurethral resection syndrome (1.4%). As the prostate has a rich blood supply, bleeding is one of the most common complications of Transurethral resection of the prostate.
- Being tested
- Tranexamic Acid group, Distilled water group
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid groupDrug
Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline
Distilled water groupDrug
This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid group | Experimental | Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline Receives: Drug: Tranexamic Acid group |
| Distilled water group | Placebo comparator | This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine). Receives: Drug: Distilled water group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Blood Loss During Monopolar transurethral resection of the prostate
The efficacy of intraprostatic injection of tranexamic acid in reducing intraoperative bleeding will be assessed in litter.
Measured: 2 weeks Postoperatively
Secondary outcomes (3)
Hemoglobin (Hb) level
This outcome evaluates the changes in hemoglobin (Hb) level before and after the monopolar transurethral resection of the prostate (TURP) procedure.
Measured: 2 weeks Postoperatively
Hematocrit (HCT) Level
This outcome evaluates the changes in hematocrit (HCT) level before and after the monopolar transurethral resection of the prostate (TURP) procedure.
Measured: 2 weeks Postoperatively
Postoperative hospital stay length
Postoperative hospital stay length will be assessed in days
Measured: 2 weeks Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start20 Jun 2023 (estimated)
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Abd El-Wahab Diab, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913466
- Sponsor's protocol ID
- Rc 5-5-2022
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be available under a clear request for the primary investigator
Publications
Diab T, El Hamshary SA, Abou Elezz A, El-Dakhakhny AS. Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar Transurethral Resection of the Prostate: A Randomized Controlled Clinical Trial. Urology. 2024 Sep;191:119-126. doi: 10.1016/j.urology.2024.05.015. Epub 2024 May 22.
PubMed 38788904
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP
- ClinicalTrials.gov ID
- NCT05913466
- Acronym / sponsor ID
- Rc 5-5-2022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (estimated)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 22 Jun 2023 (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 study aims to assess the role of intraprostatic injection of tranexamic acid in decreasing the blood loss during Transurethral resection of the prostate.
Detailed description
Benign prostatic hyperplasia (BPH) is a process in which the pathology results in increased number of both stromal and epithelial cells in the area of the prostate around the urethra, which is pathologically known as hyperplasia, and not hypertrophy.
The accurate cause is not well known; however, "reactivation" of embryonic processes is one of the hypotheses that may cause benign prostatic hyperplasia (BPH). Benign prostatic hyperplasia (BPH) is a common condition that affects elderly men. Recently, many noninvasive and mini-invasive modalities have become popular for the management of men with voiding symptoms.
Transurethral resection of the prostate (TURP) is one of the most common and well-developed techniques used to treat benign prostatic hyperplasia (BPH), recognized as the 'gold standard' of the surgical treatments of enlarged prostates. The most relevant complications are the inability to void (5.8%), surgical revision (5.6%), urinary tract infection (UTI) (3.6%), bleeding requiring transfusions (2.9%), and Transurethral resection syndrome (1.4%). As the prostate has a rich blood supply, bleeding is one of the most common complications of Transurethral resection of the prostate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid group | Experimental | Drug: Tranexamic Acid groupPatients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline |
| Distilled water group | Placebo comparator | Drug: Distilled water groupThis group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with an age between 50 and 85 years old
- who had benign prostatic hyperplasia (aged 50-85 years) with a prostate weight of 50-80 g.
- undergoing Transurethral resection of the prostate
Key exclusion criteria (5 listed)
- Patient refusal.
- Patients hypersensitive to Tranexamic Acid, or on antiplatelet and anticoagulant drugs.
- Patients with a history of thrombotic events, bleeding disorders, chronic kidney disease.
- Patients with abnormal liver function test.
- Patients with cardiovascular disease and receiving with a drug-eluting stent, bladder stone, urethral stricture, or with previous prostate surgery, prostate cancer, with a UTI or who receiving 5α-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 |
|---|---|---|
| Tranexamic Acid groupPatients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline | Drug | Tranexamic Acid group |
| Distilled water groupThis group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine). | Drug | Distilled water group |
Primary outcome
Amount of Blood Loss During Monopolar transurethral resection of the prostate
Time frame: 2 weeks Postoperatively
The efficacy of intraprostatic injection of tranexamic acid in reducing intraoperative bleeding will be assessed in litter.
3 secondary outcomes
Hemoglobin (Hb) level
Time frame: 2 weeks Postoperatively
Hematocrit (HCT) Level
Time frame: 2 weeks Postoperatively
Postoperative hospital stay length
Time frame: 2 weeks Postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 38788904Diab T, El Hamshary SA, Abou Elezz A, El-Dakhakhny AS. Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar Transurethral Resection of the Prostate: A Randomized Controlled Clinical Trial. Urology. 2024 Sep;191:119-126. doi: 10.1016/j.urology.2024.05.015. Epub 2024 May 22.
- Individual participant dataSharing planned: Yes. The study protocol will be available under a clear request for the primary investigator
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid group and Distilled water group in people with Benign Prostatic Hyperplasia and Transurethral Resection of the Prostate, run by Benha University.
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 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamer Diab, MD (01003583264 ext. +2, tamer.diab@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Blood Loss During Monopolar transurethral resection of the prostate (time frame: 2 weeks Postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05913466, which also lists 1 linked publication.
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 22 Jun 2023.