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出境医 / 临床实验 / Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study (BPH)
Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study (BPH)
Study Description
Brief Summary:
To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| BPH With Urinary Obstruction Male | Procedure: Holmium laser enucleation of the prostate Procedure: Bipolar plasma kinetic enucleation of the prostate | Not Applicable |
Detailed Description:
To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (>80gm).
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 64 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Holmium Laser Enucleation Versus Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: a Randomised Controlled Study |
| Actual Study Start Date : | November 1, 2016 |
| Actual Primary Completion Date : | February 14, 2018 |
| Actual Study Completion Date : | March 8, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: HoLEP holmium laser enucleation of the prostate
holmium laser enucleation of the prostate
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Procedure: Holmium laser enucleation of the prostate
cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W)
Other Name: HoLEP
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Active Comparator: BPEP bipolar plasmakinetic enucleation of the prostate
bipolar plasmakinetic enucleation of the prostate
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Procedure: Bipolar plasma kinetic enucleation of the prostate
cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad)
Other Name: BPEP
|
Outcome Measures
Primary Outcome Measures :
- hemoglobin drop postoperatively (gm/dL) [ Time Frame: Immediate postoperatively ]difference in hemoglobin concentration postoperatively vs preoperatively
- operative time [ Time Frame: during surgery ]operative time in minutes
Secondary Outcome Measures :
- complications (%) [ Time Frame: one year ]intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention.
- urine flow [ Time Frame: one year ]Qmax (ml/s),
- post-voiding residual urine [ Time Frame: one year ]postvoiding residual urine (ml)
- International prostate symptom score (IPSS) [ Time Frame: one year ]an international commonly used score ranging from 0 - 35 (the worst is 35) evaluating voiding and storage urinary symptoms using 7 questions each one is scored from 0 to 5 according to severity of symptom
- Quality of life (QoL) section of International prostate symptom score (IPSS) [ Time Frame: one year ]one question scored from 0 up to 6 (6 is worst)
Eligibility Criteria
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients suffering from LUTS secondary to infravesical obstruction from BPH
- failed medical treatment
- International Prostate Symptom Score (IPSS) > 13
- a peak urinary flow rate (Qmax) < 15 ml/sec
- a prostate size ≥ 80 gm
Exclusion Criteria:
- presence of a urethral stricture
- neurological disorder
- bladder cancer
- prostate cancer
- previous history of bladder neck surgery or TURP
Contacts and Locations
Locations
| Egypt | |
| Cairo University Hospitals | |
| Cairo, Egypt, 12222 | |
Sponsors and Collaborators
Cairo University
Theodor Bilharz Research Institute
Investigators
| Study Director: | enmar I Habib, Prof. | Cairo University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 14, 2019 | ||||
| First Posted Date ICMJE | June 26, 2019 | ||||
| Last Update Posted Date | June 27, 2019 | ||||
| Actual Study Start Date ICMJE | November 1, 2016 | ||||
| Actual Primary Completion Date | February 14, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study | ||||
| Official Title ICMJE | Holmium Laser Enucleation Versus Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: a Randomised Controlled Study | ||||
| Brief Summary | To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH. | ||||
| Detailed Description | To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (>80gm). | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Habib E, Ayman LM, ElSheemy MS, El-Feel AS, Elkhouly A, Nour HH, Badawy MH, Elbaz AG, Roshdy MA. Holmium Laser Enucleation vs Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: A Randomized Controlled Trial. J Endourol. 2020 Mar;34(3):330-338. doi: 10.1089/end.2019.0707. Epub 2020 Feb 28. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
64 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | March 8, 2019 | ||||
| Actual Primary Completion Date | February 14, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 40 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Egypt | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03998150 | ||||
| Other Study ID Numbers ICMJE | 61647 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Mohammed Said ElSheemy, Cairo University | ||||
| Study Sponsor ICMJE | Cairo University | ||||
| Collaborators ICMJE | Theodor Bilharz Research Institute | ||||
| Investigators ICMJE |
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| PRS Account | Cairo University | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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