Prostatic HyperplasiaNCT06294366
Bipolar Transurethral Enucleation Versus Resection in the Treatment of Benign Prostatic Hyperplasia: a Comparative Study
A study testing Bipolar Bowa device in people with Prostatic Hyperplasia and Prostate Enucleation, run by Menoufia University at 1 site in Egypt.
Trial summary
Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men . Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased . Read more about this study
- Who is it for?
- Ages 50 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Hyperplasia, Prostate Enucleation
- What is being tested?
- Bipolar Bowa device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jun 2022to 30 Oct 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 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients with symptomatizing BPH who have a prostate volume > 60 gm and indicated for surgical treatment.
Who cannot join
- patients with small fibrotic prostates, high PSA (not co-inciding with BPH), neurogenic bladder.
Trial locations and contacts
1 site in 1 country.
About this study
Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men .
Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased . BPH can be treated either with watchful waiting, drug therapy, or surgery being the most effective treatment option for BPH .
Transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH with morbidity rate varies from 18% and 26% Until now, only open prostatectomy and transurethral Holmium laser enucleation of the prostate (HoLEP) have shown an equal efficacy and durability compared to TURP
Read the detailed description
Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men.
Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased. BPH can be treated either with watchful waiting, drug therapy, or surgery being the most effective treatment option for BPH.
Transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH with morbidity rate varies from 18% and 26%.
Until now, only open prostatectomy and transurethral Holmium laser enucleation of the prostate (HoLEP) have shown an equal efficacy and durability compared to TURP.
An increasing number of endoscopic techniques have been attempted to overcome these complications. One of the technical modifications of TURP is the bipolar transurethral resection of the prostate (B-TURP) which enables urologists to use normal saline solution as an irrigation fluid to overcome the risk of TUR syndrome occurrence and requires less energy.
Currently bipolar TURP is considered a valid alternative to monopolar TURP offering similar efficacy with lower peri-operative morbidity.
Moreover, the bipolar system can also be used to enucleate entire large prostate glands, achieving an effective alternative to TURP and open simple prostatectomy (OP), and reducing complications associated with these techniques, including risk of bleeding and blood transfusion.
The crux of the idea behind enucleation is that it depends on removing the prostatic tissue along the surgical capsule as in open prostatectomy, but in a minimally invasive setting, with the same tissue removal capability.
Despite a growing amount of data reported in the literature, it remains unclear how PKEP compares to more established B-TURP in the surgical treatment of BPH
The aim of the study is to assess the surgical efficacy, safety, and peri-operative morbidity of bipolar plasmakinetic enucleation of the prostate (PKEP) in comparison with bipolar transurethral resection of the prostate (B-TURP) for the treatment of patients with symptomatizing prostates.
A prospective randomized controlled study was conducted in 52 patients diagnosed with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) whose prostates > 60 gm. The perioperative parameters, therapeutic effects and complications were compared between the two groups before and 3 months after surgery.
Preoperative evaluation included detailed medical history, thorough clinical examination, International Prostate Symptom Score (IPSS), digital rectal examination (DRE), prostate volume, post-voiding residual urinary volume (PVR), PSA level and maximum flow rate (Qmax).
Intraoperative evaluation included operative time, irrigating fluid volume, the volume of removed prostate tissue, blood loss, and intraoperative complications.
Postoperative evaluation included the mean hemoglobin and hematocrit differences, catheterization period, hospital stay, postoperative complications and follow up IPSS, PVR and Qmax.
- Conditions
- Prostatic Hyperplasia, Prostate Enucleation
- Being tested
- Bipolar Bowa device
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar Bowa deviceDevice
Bipolar Bowa device used in prostatic resection and enucleation
| Study group | Role | What they receive |
|---|---|---|
| Bipolar enucleation | Active comparator | Bipolar enucleation of the prostate larger than 60 gm Receives: Device: Bipolar Bowa device |
| Bipolar TURP | Active comparator | Bipolar transurethral resection of the prostate larger than 60 gm Receives: Device: Bipolar Bowa device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing and comparing the safety, the surgical efficacy and peri-operative morbidity of bipolar enucleation of the prostate and bipolar transurethral resection of the prostate for the treatment of patients with symptomatizing prostates.
Preoperative evaluation will include detailed medical history, thorough clinical examination, international prostate symptom score (IPSS), digital rectal examination (DRE), prostate specific antigen [Prostatic specific antigen (free/total)], maximum flow rate (Qmax), and pelvi-abdominal ultrasound to assess prostate size and post-voiding residual urinary volume (PVR).
Intraoperative evaluation will include operative time, irrigating fluid volume, the volume of removed prostate tissue, and intraoperative complications.
Postoperative evaluation will include the mean haemoglobin difference, hematocrit level, catheterization period, hospital stay, medications, analgesics, and follow up maximum flow rate (Qmax).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start12 Jun 2022
- Primary completion1 Jul 2024
- Study completion30 Oct 2024
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.
- More trials run by Menoufia 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
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelgawad Rokba, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294366
- Sponsor's protocol ID
- MenoufiaU2022
- Status last verified
- Nov 2024
- First submitted
- 2 Jan 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Transurethral Enucleation Versus Resection in the Treatment of Benign Prostatic Hyperplasia: a Comparative Study
- ClinicalTrials.gov ID
- NCT06294366
- Acronym / sponsor ID
- MenoufiaU2022
- Conditions
- Prostatic Hyperplasia, Prostate Enucleation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 12 Jun 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 5 Mar 2024 (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.
Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men .
Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased . BPH can be treated either with watchful waiting, drug therapy, or surgery being the most effective treatment option for BPH .
Transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH with morbidity rate varies from 18% and 26% Until now, only open prostatectomy and transurethral Holmium laser enucleation of the prostate (HoLEP) have shown an equal efficacy and durability compared to TURP
Detailed description
Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men.
Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased. BPH can be treated either with watchful waiting, drug therapy, or surgery being the most effective treatment option for BPH.
Transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH with morbidity rate varies from 18% and 26%.
Until now, only open prostatectomy and transurethral Holmium laser enucleation of the prostate (HoLEP) have shown an equal efficacy and durability compared to TURP.
An increasing number of endoscopic techniques have been attempted to overcome these complications. One of the technical modifications of TURP is the bipolar transurethral resection of the prostate (B-TURP) which enables urologists to use normal saline solution as an irrigation fluid to overcome the risk of TUR syndrome occurrence and requires less energy.
Currently bipolar TURP is considered a valid alternative to monopolar TURP offering similar efficacy with lower peri-operative morbidity.
Moreover, the bipolar system can also be used to enucleate entire large prostate glands, achieving an effective alternative to TURP and open simple prostatectomy (OP), and reducing complications associated with these techniques, including risk of bleeding and blood transfusion.
The crux of the idea behind enucleation is that it depends on removing the prostatic tissue along the surgical capsule as in open prostatectomy, but in a minimally invasive setting, with the same tissue removal capability.
Despite a growing amount of data reported in the literature, it remains unclear how PKEP compares to more established B-TURP in the surgical treatment of BPH
The aim of the study is to assess the surgical efficacy, safety, and peri-operative morbidity of bipolar plasmakinetic enucleation of the prostate (PKEP) in comparison with bipolar transurethral resection of the prostate (B-TURP) for the treatment of patients with symptomatizing prostates.
A prospective randomized controlled study was conducted in 52 patients diagnosed with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) whose prostates > 60 gm. The perioperative parameters, therapeutic effects and complications were compared between the two groups before and 3 months after surgery.
Preoperative evaluation included detailed medical history, thorough clinical examination, International Prostate Symptom Score (IPSS), digital rectal examination (DRE), prostate volume, post-voiding residual urinary volume (PVR), PSA level and maximum flow rate (Qmax).
Intraoperative evaluation included operative time, irrigating fluid volume, the volume of removed prostate tissue, blood loss, and intraoperative complications.
Postoperative evaluation included the mean hemoglobin and hematocrit differences, catheterization period, hospital stay, postoperative complications and follow up IPSS, PVR and Qmax.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar enucleation | Active comparator | Device: Bipolar Bowa deviceBipolar enucleation of the prostate larger than 60 gm |
| Bipolar TURP | Active comparator | Device: Bipolar Bowa deviceBipolar transurethral resection of the prostate larger than 60 gm |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with symptomatizing BPH who have a prostate volume > 60 gm and indicated for surgical treatment.
Key exclusion criteria (1 listed)
- patients with small fibrotic prostates, high PSA (not co-inciding with BPH), neurogenic bladder.
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 |
|---|---|---|
| Bipolar Bowa deviceBipolar Bowa device used in prostatic resection and enucleation | Device | Bipolar TURP, Bipolar enucleation |
Primary outcome
Assessing and comparing the safety, the surgical efficacy and peri-operative morbidity of bipolar enucleation of the prostate and bipolar transurethral resection of the prostate for the treatment of patients with symptomatizing prostates.
Time frame: one year
Preoperative evaluation will include detailed medical history, thorough clinical examination, international prostate symptom score (IPSS), digital rectal examination (DRE), prostate specific antigen [Prostatic specific antigen (free/total)], maximum flow rate (Qmax), and pelvi-abdominal ultrasound to assess prostate size and post-voiding residual urinary volume (PVR). Intraoperative evaluation will include operative time, irrigating fluid volume, the volume of removed prostate tissue, and intraoperative complications. Postoperative evaluation will include the mean haemoglobin difference, hematocrit level, catheterization period, hospital stay, medications, analgesics, and follow up maximum flow rate (Qmax).
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 8 Nov 2024.
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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?
A study testing Bipolar Bowa device in people with Prostatic Hyperplasia and Prostate Enucleation, run by Menoufia 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 1 inclusion and 1 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 8 Nov 2024. 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?
Assessing and comparing the safety, the surgical efficacy and peri-operative morbidity of bipolar enucleation of the prostate and bipolar transurethral resection of the prostate for the treatment of patients with symptomatizing prostates. (time frame: one year). 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 8 Nov 2024.