Benign Prostatic HyperplasiaNCT06758466
Bipolar TURP Versus Bipolar Enucleation for BPH Management
A study testing Prostate surgery in people with Benign Prostatic Hyperplasia, run by Kasr El Aini Hospital.
Trial summary
To compare the surgical outcomes at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Prostate surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 15 Mar 2028
- Phase
- Interventional
- 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged 45-80 years diagnosed with symptomatic BPH.
- Prostate volume between 30-80 grams as determined by transrectal ultrasound (TRUS) performed within 4 weeks before randomization.
- Moderate to severe LUTS with an IPSS of ≥ 8.
- Failure of medical management.
- Patients able to provide written informed consent.
Who cannot join
- History of prostate cancer.
- History of previous prostate surgery (including any procedure for BPH or prostate cancer).
- History of urethral stricture or bladder neck contracture.
- Neurogenic bladder dysfunction.
- Significant coagulopathy.
- Uncontrolled urinary tract infection.
- Patient on anticoagulant medication.
About this study
Official title: A Prospective Randomized Controlled Trial Comparing Bipolar TURP and Bipolar Enucleation of the Prostate for Benign Prostatic Hyperplasia (BPH) With Prostate Volumes Between 30-80 Grams
To compare the surgical outcomes at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams.
Read the detailed description
Create a research protocol in a prospective study to compare bipolar transurethral resection of prostate vs bipolar enucleation of prostate between 30 and 80 gm in management of BPH
Okay, here's a detailed research protocol for a prospective study comparing Bipolar Transurethral Resection of the Prostate (TURP) and Bipolar Enucleation of the Prostate (BipoLEP) for BPH, specifically focusing on prostates between 30-80 grams:
Study Title: A Prospective Randomized Controlled Trial Comparing Bipolar TURP and Bipolar Enucleation of the Prostate for Benign Prostatic Hyperplasia (BPH) with Prostate Volumes between 30-80 grams
- Introduction
Background: Briefly introduce Benign Prostatic Hyperplasia (BPH), its prevalence, and the associated lower urinary tract symptoms (LUTS). Highlight the common surgical interventions: TURP and, more recently, enucleation techniques.
Problem Statement: State that while both bipolar TURP and BipoLEP are established treatments, there's a need for a direct comparison, especially for moderate-sized prostates (30-80g). There's an ongoing debate regarding which approach offers superior outcomes and a better balance of efficacy and safety.
Rationale: Explain why this study is necessary. This can be because there is limited direct
Primary Objective: To compare the International Prostate Symptom Score (IPSS) at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams.
Secondary Objectives:
To compare perioperative outcomes including:
Operative time (minutes)
Catheterization time (days)
Length of hospital stay (days)
Blood loss (change in hemoglobin)
Requirement of blood transfusion
Incidence of perioperative complications (e.g., TUR syndrome, bleeding, infection, clot retention)
To compare postoperative functional outcomes including:
Peak urinary flow rate (Qmax) at 3, 6, and 12 months
Post-void residual (PVR) volume at 3, 6, and 12 months
Quality of life (QoL) using a validated questionnaire at 3, 6, and 12 months
To compare the incidence of postoperative complications including:
Urinary tract infection (UTI)
Urinary incontinence (UI)
Urethral stricture
Bladder neck contracture
Need for re-operation within 12 months.
To compare overall patient satisfaction using a visual analog scale (VAS) at 3, 6, and 12 months
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Prostate surgery
- Keywords
- BPH - Bipolar- TURP - Enucleation
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate surgeryProcedure or surgery
Prostate removal
| Study group | Role | What they receive |
|---|---|---|
| Bipolar enucleation | Active comparator | Not described Receives: Procedure: Prostate surgery |
| Bipolar resection | Active comparator | Not described Receives: Procedure: Prostate surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS)
Measured: 12 months
Qmax
Measured: 12 months
Secondary outcomes (2)
PVR
Measured: 12 months
Complications
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samer Morsy, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758466
- Sponsor's protocol ID
- Kasr Alainy- Cairo University
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 3 Jan 2025
- 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 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Bipolar TURP and Bipolar Enucleation of the Prostate for Benign Prostatic Hyperplasia (BPH) With Prostate Volumes Between 30-80 Grams
- ClinicalTrials.gov ID
- NCT06758466
- Acronym / sponsor ID
- Kasr Alainy- Cairo University
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH - Bipolar- TURP - Enucleation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 3 Jan 2025 (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.
To compare the surgical outcomes at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams.
Detailed description
Create a research protocol in a prospective study to compare bipolar transurethral resection of prostate vs bipolar enucleation of prostate between 30 and 80 gm in management of BPH
Okay, here's a detailed research protocol for a prospective study comparing Bipolar Transurethral Resection of the Prostate (TURP) and Bipolar Enucleation of the Prostate (BipoLEP) for BPH, specifically focusing on prostates between 30-80 grams:
Study Title: A Prospective Randomized Controlled Trial Comparing Bipolar TURP and Bipolar Enucleation of the Prostate for Benign Prostatic Hyperplasia (BPH) with Prostate Volumes between 30-80 grams
- Introduction
Background: Briefly introduce Benign Prostatic Hyperplasia (BPH), its prevalence, and the associated lower urinary tract symptoms (LUTS). Highlight the common surgical interventions: TURP and, more recently, enucleation techniques.
Problem Statement: State that while both bipolar TURP and BipoLEP are established treatments, there's a need for a direct comparison, especially for moderate-sized prostates (30-80g). There's an ongoing debate regarding which approach offers superior outcomes and a better balance of efficacy and safety.
Rationale: Explain why this study is necessary. This can be because there is limited direct
Primary Objective: To compare the International Prostate Symptom Score (IPSS) at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams.
Secondary Objectives:
To compare perioperative outcomes including:
Operative time (minutes)
Catheterization time (days)
Length of hospital stay (days)
Blood loss (change in hemoglobin)
Requirement of blood transfusion
Incidence of perioperative complications (e.g., TUR syndrome, bleeding, infection, clot retention)
To compare postoperative functional outcomes including:
Peak urinary flow rate (Qmax) at 3, 6, and 12 months
Post-void residual (PVR) volume at 3, 6, and 12 months
Quality of life (QoL) using a validated questionnaire at 3, 6, and 12 months
To compare the incidence of postoperative complications including:
Urinary tract infection (UTI)
Urinary incontinence (UI)
Urethral stricture
Bladder neck contracture
Need for re-operation within 12 months.
To compare overall patient satisfaction using a visual analog scale (VAS) at 3, 6, and 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar enucleation | Active comparator | Procedure: Prostate surgery |
| Bipolar resection | Active comparator | Procedure: Prostate surgery |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients aged 45-80 years diagnosed with symptomatic BPH.
- Prostate volume between 30-80 grams as determined by transrectal ultrasound (TRUS) performed within 4 weeks before randomization.
- Moderate to severe LUTS with an IPSS of ≥ 8.
- Failure of medical management.
- Patients able to provide written informed consent.
Key exclusion criteria (7 listed)
- History of prostate cancer.
- History of previous prostate surgery (including any procedure for BPH or prostate cancer).
- History of urethral stricture or bladder neck contracture.
- Neurogenic bladder dysfunction.
- Significant coagulopathy.
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 |
|---|---|---|
| Prostate surgeryProstate removal | Procedure or surgery | Bipolar enucleation, Bipolar resection |
Primary outcome
International Prostate Symptom Score (IPSS)
Time frame: 12 months
Qmax
Time frame: 12 months
2 secondary outcomes
PVR
Time frame: 12 months
Complications
Time frame: 12 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 3 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate surgery in people with Benign Prostatic Hyperplasia, run by Kasr El Aini Hospital.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 3 Jan 2025. 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. 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?
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?
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?
International Prostate Symptom Score (IPSS) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 2025.