Bipolar TURP , Laser Enucleation in Management of Enlarged ProstateNCT05784181
Bipolar Versus Laser Enaculation of Prostate for >80gram Prostate .
A study testing bipolar transurethral resection and Laser enaculation by holmium: YAG laser in people with Bipolar TURP , Laser Enucleation in Management of Enlarged Prostate, run by Menoufia University at 1 site in Egypt.
Trial summary
Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation. Holmium laser prostatectomy was introduced since 1994 . Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bipolar TURP , Laser Enucleation in Management of Enlarged Prostate
- What is being tested?
- bipolar transurethral resection and Laser enaculation by holmium: YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Dec 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 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- similar for all patients prostatic volume more than 80 gm , peak urinary flow rate measurement (Qmax) <15 ml/s, International Prostate Symptom Score (IPSS) of >8 , postvoid residual (PVR) <400 ml
Who cannot join
- Patients with prostate size less than 80gm , urethral stricture, acute urinary tract infection, repeated treatment .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Shibīn al Kawm, Menoufia -, 12345
About this study
Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation.
Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications .
One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection .
Read the detailed description
Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation.
Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications .
One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection , so , we try to analyze the effect of Laser enaculation of the prostate in comparison to Bipolar resection in prostate more than 80 gm .
Aim of the work:
Aim of the work is to compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.
Patients and Methods:
A randomized comparative study will be conducted at Menoufia university hospital , urology department. patients will be selected after informed consent.
Inclusion criteria: similar for all patients prostatic volume more than 80 gm , peak urinary flow rate measurement (Qmax) <15 ml/s, International Prostate Symptom Score (IPSS) of >8 , postvoid residual (PVR) <400 ml.
Exclusion criteria: Patients with prostate size less than 80gm , urethral stricture, acute urinary tract infection, repeated treatment .
Preoperatively, all the patients will undergo thorough process of history taking , clinical examination, and investigations in the form of abdominopelvic and trans rectal ultrasonography , PSA ,urine analysis, urine culture if needed and routine pre-operative lab investigations as (CBC , PT, LFTs, serum creatinine and RBS).
The treatment modality chosen for an individual will be randomized . All patients with positive urine culture will be treated by proper antibiotics before the procedures.
Peri-operatively , all patients will receive a single shot of pre-operative antibiotic.
For the first group patients transurethral resection of prostate For the second group patients Laser enaculation by holmium: YAG laser Postoperatively, patients will undergo IPSS score , flowmetry post operative after 3months .
- Being tested
- bipolar transurethral resection and Laser enaculation by holmium: YAG laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bipolar transurethral resection and Laser enaculation by holmium: YAG laserDevice
Laser enaculation by holmium: YAG laser
| Study group | Role | What they receive |
|---|---|---|
| patients prostatic volume more than 80 gm turp by bipolar resection | Other | pt with 80gm prostate size underwent bipolar resection Receives: Device: bipolar transurethral resection and Laser enaculation by holmium: YAG laser |
| patients prostatic volume more than 80 gm turp by Laser enaculation by holmium: YAG laser | Other | pt with 80gm prostate size underwent Laser enaculation by holmium: YAG laser Receives: Device: bipolar transurethral resection and Laser enaculation by holmium: YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.
compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Oct 2021
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar TURP , Laser Enucleation in Management of Enlarged ProstateStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Kandeel, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784181
- Sponsor's protocol ID
- 2-2022
- Status last verified
- Jan 2024
- First submitted
- 8 Feb 2022
- Last updated
- 3 Jan 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Versus Laser Enaculation of Prostate for >80gram Prostate .
- ClinicalTrials.gov ID
- NCT05784181
- Acronym / sponsor ID
- 2-2022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Mar 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.
Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation.
Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications .
One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection .
Detailed description
Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation.
Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications .
One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection , so , we try to analyze the effect of Laser enaculation of the prostate in comparison to Bipolar resection in prostate more than 80 gm .
Aim of the work:
Aim of the work is to compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.
Patients and Methods:
A randomized comparative study will be conducted at Menoufia university hospital , urology department. patients will be selected after informed consent.
Inclusion criteria: similar for all patients prostatic volume more than 80 gm , peak urinary flow rate measurement (Qmax) <15 ml/s, International Prostate Symptom Score (IPSS) of >8 , postvoid residual (PVR) <400 ml.
Exclusion criteria: Patients with prostate size less than 80gm , urethral stricture, acute urinary tract infection, repeated treatment .
Preoperatively, all the patients will undergo thorough process of history taking , clinical examination, and investigations in the form of abdominopelvic and trans rectal ultrasonography , PSA ,urine analysis, urine culture if needed and routine pre-operative lab investigations as (CBC , PT, LFTs, serum creatinine and RBS).
The treatment modality chosen for an individual will be randomized . All patients with positive urine culture will be treated by proper antibiotics before the procedures.
Peri-operatively , all patients will receive a single shot of pre-operative antibiotic.
For the first group patients transurethral resection of prostate For the second group patients Laser enaculation by holmium: YAG laser Postoperatively, patients will undergo IPSS score , flowmetry post operative after 3months .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients prostatic volume more than 80 gm turp by bipolar resection | Other | Device: bipolar transurethral resection and Laser enaculation by holmium: YAG laserpt with 80gm prostate size underwent bipolar resection |
| patients prostatic volume more than 80 gm turp by Laser enaculation by holmium: YAG laser | Other | Device: bipolar transurethral resection and Laser enaculation by holmium: YAG laserpt with 80gm prostate size underwent Laser enaculation by holmium: YAG laser |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- similar for all patients prostatic volume more than 80 gm , peak urinary flow rate measurement (Qmax) <15 ml/s, International Prostate Symptom Score (IPSS) of >8 , postvoid residual (PVR) <400 ml
Key exclusion criteria (1 listed)
- Patients with prostate size less than 80gm , urethral stricture, acute urinary tract infection, repeated treatment .
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 transurethral resection and Laser enaculation by holmium: YAG laserLaser enaculation by holmium: YAG laser | Device | patients prostatic volume more than 80 gm turp by Laser enaculation by holmium: YAG laser, patients prostatic volume more than 80 gm turp by bipolar resection |
Primary outcome
compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.
Time frame: 1 year
compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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.
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 transurethral resection and Laser enaculation by holmium: YAG laser in people with Bipolar TURP , Laser Enucleation in Management of Enlarged Prostate, 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: status not confirmed, as of the sponsor's last update on 3 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed kamal omar, MD (00201066949454, kimo_81eg@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram. (time frame: 1 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 3 Jan 2024.