Prostate ObstructionNCT04331301
Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH
A study testing Bipolar Vapo-Enucleation of the prostate and Bipolar Needlescopic Enucleation of the prostate in people with Prostate Obstruction and Prostatic Hyperplasia, run by Benha University at 1 site in Egypt.
Trial summary
Transurethral resection of the prostate (TURP) is the current standard procedure for men with prostate volume 30-80 gm. In case with large prostate adenoma (>80 g), the resection time required by TURP is associated with increased risk of TUR syndrome, blood loss and other complications. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Obstruction, Prostatic Hyperplasia, Prostatic Hypertrophy, Benign
- What is being tested?
- Bipolar Vapo-Enucleation of the prostate and Bipolar Needlescopic Enucleation of the prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2017to 10 Mar 2022
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with Qmax of less than 15 mL/second due to BPH, severe LUTS/BPH requiring surgical treatment, and International Prostate Symptom Score (IPSS)>7 due to BPH.
Who cannot join
- prostate and/or bladder cancer, bladder diverticula, urethral stricture, active urinary tract infection (UTI), unless treated, and men with neurogenic voiding dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bipolar Needlescopic Enucleation Versus Vapoenucleation of the Prostate: A Prospective Randomized Study
Transurethral resection of the prostate (TURP) is the current standard procedure for men with prostate volume 30-80 gm. In case with large prostate adenoma (>80 g), the resection time required by TURP is associated with increased risk of TUR syndrome, blood loss and other complications.
Many types of minimally invasive surgery exist along with new equipment and techniques. Many types of laser devices such as greenlight laser, thulium laser and holmium laser, are used to enucleate the prostate. Increasing evidence has proven their safety and efficacy However, the use of laser devices is difficult and associated with steep learning curve and high medical expenses.
Read more
PKEP is a safe and effective procedure for the treatment of bladder obstruction secondary to BPH. This procedure not only improves maximum flow rate at 3 and 12 months after surgery, but it also improves all other recorded parameters (IPSS, QOL, IEFF-5, PVR, PSA).
A button electrode can be effectively used to enucleate the prostate because of its powerful vaporisation and strong coagulation (B-TUEP technique) ,such as that with a holmium laser, thulium laser and greenlight laser. However its associated with short term complication as early irritative symptoms, Bulai reported that 16.7% of the patients suffering from early irritative symptoms while Geavlete reported that 11.4% of patient suffering from early irritative symptoms.
Read the detailed description
Aim: compare safety and efficacy and adverse events of endoscopic enucleation of large prostate using hot knife electrode (needloscopic enucleation) versus the standard vaporization electrode ( vapoenucleation) patients \& methods: Patients will randomly be divided into two equal groups: Group A: Patient will be subjected to bipolar endoscopic enucleation of the prostate by vaporization electrode (vapoenucleation).
Group B: Patient will be subjected to endoscopic enucleation of the prostate by bipolar hot kife electrode (needloscopic enucleation) Inclusion criteria: patients with Qmax of less than 15 mL/second due to BPH, severe LUTS/BPH requiring surgical treatment, and International Prostate Symptom Score (IPSS)>7 due to BPH.
exclusion criteria: prostate and/or bladder cancer, bladder diverticula, urethral stricture, active urinary tract infection (UTI), unless treated, and men with neurogenic voiding dysfunction.
Operative Technique: Endoscopic enucleation of the prostate in saline utilizing either bipolar vaporization electrode or bipolar hot knife (collin's) electrode.
follow up: operative time, resected tissue weight, cath time, hospital stay and change of; IPSS,QOL, Qmax, PVR, PSA, IIEF-5 \& MSHQ-EjD besides; perioperative adverse events are recorded \& followed-up.
- Being tested
- Bipolar Vapo-Enucleation of the prostate, Bipolar Needlescopic Enucleation of the prostate
- Keywords
- BPH, IPSS, Bipolar
- 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 Vapo-Enucleation of the prostateProcedure or surgery
Also called BVEP
group A: Patient will be subjected to bipolar endoscopic enucleation of the prostate by vaporization electrode (vapoenucleation).
Bipolar Needlescopic Enucleation of the prostateProcedure or surgery
Also called BNEP
group B: Patient will be subjected to bipolar endoscopic enucleation of the prostate by hot knife electrode (Needlescopic Enucleation ).
| Study group | Role | What they receive |
|---|---|---|
| vapoenucleation group | Active comparator | Group A Receives: Procedure: Bipolar Vapo-Enucleation of the prostate |
| needlescopic enucleation | Active comparator | group B Receives: Procedure: Bipolar Needlescopic Enucleation of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPSS
international prostate symptoms score (range 0 -35, the lower value is better)
Measured: change of IPSS from Basline at 1,3 and 6 months postoperatively
Secondary outcomes (4)
QOL
Quality of life questionnaire (range 0 - 6, the lower value is better)
Measured: Change of QOL from Basline at 1,3 and 6 months postoperatively
Qmax
maximum urinary flow rate (it ranges from 0(retention) to 25 mL/s or more the higher value is better)
Measured: Change of Qmax from Basline at 1,3 and 6 months postoperatively
PVRU
Post-operative residual urine (volume it ranges from 0 ml (normal) to more than 1 liter the lower value is better
Measured: Change of PVRU from Basline at 1,3 and 6 months postoperatively
TRUS measured prostate volume
Prostate volume measured by Transrectal Ultrasonography the lower value is better
Measured: Change of PV from Basline at 1,3 and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start10 Jan 2017
- Primary completion1 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate ObstructionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed El-Shaer, MD, Benha University
- Investigators
- Waleed El-Shaer, Principal investigator, waleed_elshaer@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331301
- Sponsor's protocol ID
- IDIRB2017122601-09
- Status last verified
- Apr 2022
- First submitted
- 29 Mar 2020
- Last updated
- 2 May 2022
- 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 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Needlescopic Enucleation Versus Vapoenucleation of the Prostate: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04331301
- Acronym / sponsor ID
- IDIRB2017122601-09
- Keywords
- BPH, IPSS, Bipolar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 2 Apr 2020 (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.
Transurethral resection of the prostate (TURP) is the current standard procedure for men with prostate volume 30-80 gm. In case with large prostate adenoma (>80 g), the resection time required by TURP is associated with increased risk of TUR syndrome, blood loss and other complications.
Many types of minimally invasive surgery exist along with new equipment and techniques. Many types of laser devices such as greenlight laser, thulium laser and holmium laser, are used to enucleate the prostate. Increasing evidence has proven their safety and efficacy However, the use of laser devices is difficult and associated with steep learning curve and high medical expenses.
PKEP is a safe and effective procedure for the treatment of bladder obstruction secondary to BPH. This procedure not only improves maximum flow rate at 3 and 12 months after surgery, but it also improves all other recorded parameters (IPSS, QOL, IEFF-5, PVR, PSA).
A button electrode can be effectively used to enucleate the prostate because of its powerful vaporisation and strong coagulation (B-TUEP technique) ,such as that with a holmium laser, thulium laser and greenlight laser. However its associated with short term complication as early irritative symptoms, Bulai reported that 16.7% of the patients suffering from early irritative symptoms while Geavlete reported that 11.4% of patient suffering from early irritative symptoms.
Detailed description
Aim: compare safety and efficacy and adverse events of endoscopic enucleation of large prostate using hot knife electrode (needloscopic enucleation) versus the standard vaporization electrode ( vapoenucleation) patients \& methods: Patients will randomly be divided into two equal groups: Group A: Patient will be subjected to bipolar endoscopic enucleation of the prostate by vaporization electrode (vapoenucleation).
Group B: Patient will be subjected to endoscopic enucleation of the prostate by bipolar hot kife electrode (needloscopic enucleation) Inclusion criteria: patients with Qmax of less than 15 mL/second due to BPH, severe LUTS/BPH requiring surgical treatment, and International Prostate Symptom Score (IPSS)>7 due to BPH.
exclusion criteria: prostate and/or bladder cancer, bladder diverticula, urethral stricture, active urinary tract infection (UTI), unless treated, and men with neurogenic voiding dysfunction.
Operative Technique: Endoscopic enucleation of the prostate in saline utilizing either bipolar vaporization electrode or bipolar hot knife (collin's) electrode.
follow up: operative time, resected tissue weight, cath time, hospital stay and change of; IPSS,QOL, Qmax, PVR, PSA, IIEF-5 \& MSHQ-EjD besides; perioperative adverse events are recorded \& followed-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vapoenucleation group | Active comparator | Procedure: Bipolar Vapo-Enucleation of the prostateGroup A |
| needlescopic enucleation | Active comparator | Procedure: Bipolar Needlescopic Enucleation of the prostategroup B |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with Qmax of less than 15 mL/second due to BPH, severe LUTS/BPH requiring surgical treatment, and International Prostate Symptom Score (IPSS)>7 due to BPH.
Key exclusion criteria (1 listed)
- prostate and/or bladder cancer, bladder diverticula, urethral stricture, active urinary tract infection (UTI), unless treated, and men with neurogenic voiding dysfunction.
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 Vapo-Enucleation of the prostateAlso: BVEPgroup A: Patient will be subjected to bipolar endoscopic enucleation of the prostate by vaporization electrode (vapoenucleation). | Procedure or surgery | vapoenucleation group |
| Bipolar Needlescopic Enucleation of the prostateAlso: BNEPgroup B: Patient will be subjected to bipolar endoscopic enucleation of the prostate by hot knife electrode (Needlescopic Enucleation ). | Procedure or surgery | needlescopic enucleation |
Primary outcome
IPSS
Time frame: change of IPSS from Basline at 1,3 and 6 months postoperatively
international prostate symptoms score (range 0 -35, the lower value is better)
4 secondary outcomes
QOL
Time frame: Change of QOL from Basline at 1,3 and 6 months postoperatively
Qmax
Time frame: Change of Qmax from Basline at 1,3 and 6 months postoperatively
PVRU
Time frame: Change of PVRU from Basline at 1,3 and 6 months postoperatively
TRUS measured prostate volume
Time frame: Change of PV from Basline at 1,3 and 6 months postoperatively
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 2 May 2022.
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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.
Waleed El-Shaer principal investigator
waleed_elshaer@hotmail.com
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 Vapo-Enucleation of the prostate and Bipolar Needlescopic Enucleation of the prostate in people with Prostate Obstruction and Prostatic Hyperplasia, 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 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 2 May 2022. 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?
IPSS (time frame: change of IPSS from Basline at 1,3 and 6 months postoperatively). 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 2 May 2022.