Thulium Laser Versus Bipolar Enucleation of the Prostate
Primary Purpose
Benign Prostatic Hyperplasia
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thulium laser enucleation of the prostate
Bipolar enucleation of the prostate
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia, Thulium laser enucleation, Bipolar enucleation, Anatomic enucleation of the prostate, Endoscopic Enucleation of the prostate, Thulium laser, Bipolar Plasma energy
Eligibility Criteria
Inclusion Criteria:
- Patients with BPH who are unsatisfied with medical treatment having a Qmax of less than 15 cm/s.
- Patients with BPH who had refractory retention.
- Patients with complicated BPH (eg; chronic retention, refractory hematuria, bladder stones).
- Prostate size of at least 80 grams or more.
Exclusion Criteria:
- Patients with a bladder mass.
- Patients with prostate cancer.
- Patients suffering from a urethral stricture.
- Patients with previous endoscopic or surgical prostate intervention.
- Prostate size less than 80 grams.
Sites / Locations
- Kasr AlAiny School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Thulium Laser Enucleation
Bipolar Enucleation
Arm Description
Patients in this arm will undergo thulium laser enucleation of the prostate.
Patients in this arm will undergo bipolar enucleation of the prostate.
Outcomes
Primary Outcome Measures
Effect on the operative time and other intra-operative and post-operative parameters
Effect of the chosen technique on the operative time including both enucleation and morcellation times.
The occurrence of any inta-operative complications including significant blood loss necessitating blood transfusion, capsular perforation, sub-trigonal dissection and complications related to morcellation for example bladder perforation.
The occurrence of any post-operative complications which is divided into either immediate post-operative and long term complications.
Immediate post-operative complications occurring in the first 48 hours after enucleation include affection of the hemodynamics and vital signs of the patient, drop in hemoglobin level, high grade fever or uro-sepsis, retention with re-catheterization, hematuria with clot retention.
long term complications occurring include persistent urge or stress urinary incontinence, secondary hemorrhage with hematuria and clot retention, recurrent urinary tract infections, urethral stricture or bladder neck contracture.
Secondary Outcome Measures
Change of the urine flow of the patients.
Improvement of the uroflowmetry parameters after catheter removal especially the Qmax (maximum flow rate), Qavg (Average flow rate) in addition to a bell shaped curve in the flowmetry plotted curve.
Change of the IPSS (International Prostatic Symptom Score) of the patients
Improvement of the IPSS score of the patients after catheter removal compared to the value of the IPSS before enucleation.
Values of the IPSS:
Mild Symptoms from 1 to 7 Moderate Symptoms from 8 to 19 Severe Symptoms from 20 to 35
Change of residual urine volume after surgery
Reduction in the amount of residual urine by US after catheter removal below 150 cc.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05200065
Brief Title
Thulium Laser Versus Bipolar Enucleation of the Prostate
Official Title
Prospective Randomized Study Comparing the Intra-operative and Post-operative Outcomes of Bipolar Enucleation of the Prostate Versus Thulium Laser Enucleation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparing the peri-operative outcomes in patients with benign prostatic hyperplasia (BPH) who will undergo bipolar enucleation of the prostate versus thulium laser enucleation.
Detailed Description
Benign prostatic hyperplasia (BPH) is one of the most common and bothersome diseases influencing the quality of life of aging males. For decades, transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH .Recently, endoscopic laser treatments of BPH has been developed as the result of advances in laser technology and better understanding of tissue-laser interactions and nowadays it represents a challenge for TURP as regards the peri-operative outcomes.
Both the European Association of Urology (EAU) and American Urological Association (AUA) recommend endoscopic enucleation of the prostate (EEP) as one of the techniques for management of benign prostatic hyperplasia (BPH) with various techniques that could be implemented including enbloc and three/two lobe enucleation.
The classical laser enucleation technique consists of a three-lobe enucleation of the adenoma with separate enucleation of the median and lateral lobes. Scoffone and Cracco developed an "en-bloc" enucleation technique for HoLEP (holmium laser enucleation) in 2016, showing a potential role to ease some difficult intraoperative steps of enucleation and to improve the learning curve and both of the techniques mentioned were found to be applicable for bipolar endoscopic enucleation as well.
Regarding the thulium laser physical properties; its wavelength is very close to the peak for absorption in water about 1940 nm being similar to the holmium laser wavelength which is about 2010 nm. However, unlike the pulsed wave holmium laser, this high density energy of thulium laser is best delivered in a continuous wave. This is translated into more efficient vaporization and shallower depth of penetration in tissue, which has been reported to be 0.2 mm as compared with 0.4 mm for holmium lasers. In thulium laser; the continuous wave mode is more suitable for hemostasis and coagulation of tissue, whereas the pulsed mode is more suited for lithotripsy.
BipolEP (Bipolar enucleation of the prostate) has been performed as an effective method for the management of BPH in some institutions. Bipolar enucleation of prostate is a done using energy source of a bipolar electrosurgical unit. Enucleated prostatic tissues are then removed with a morcellator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Benign Prostatic Hyperplasia, Thulium laser enucleation, Bipolar enucleation, Anatomic enucleation of the prostate, Endoscopic Enucleation of the prostate, Thulium laser, Bipolar Plasma energy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized study comparing two techniques of endoscopic enucleation of the prostate.
Masking
Participant
Masking Description
Prospective randomized study comparing the two techniques with patient allocation using computer generated randomization.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thulium Laser Enucleation
Arm Type
Experimental
Arm Description
Patients in this arm will undergo thulium laser enucleation of the prostate.
Arm Title
Bipolar Enucleation
Arm Type
Experimental
Arm Description
Patients in this arm will undergo bipolar enucleation of the prostate.
Intervention Type
Procedure
Intervention Name(s)
Thulium laser enucleation of the prostate
Intervention Description
Using the thulium laser to achieve complete endoscopic enucleation of the prostate.
Intervention Type
Procedure
Intervention Name(s)
Bipolar enucleation of the prostate
Intervention Description
Using the bipolar plasma energy to achieve complete endoscopic enucleation of the prostate.
Primary Outcome Measure Information:
Title
Effect on the operative time and other intra-operative and post-operative parameters
Description
Effect of the chosen technique on the operative time including both enucleation and morcellation times.
The occurrence of any inta-operative complications including significant blood loss necessitating blood transfusion, capsular perforation, sub-trigonal dissection and complications related to morcellation for example bladder perforation.
The occurrence of any post-operative complications which is divided into either immediate post-operative and long term complications.
Immediate post-operative complications occurring in the first 48 hours after enucleation include affection of the hemodynamics and vital signs of the patient, drop in hemoglobin level, high grade fever or uro-sepsis, retention with re-catheterization, hematuria with clot retention.
long term complications occurring include persistent urge or stress urinary incontinence, secondary hemorrhage with hematuria and clot retention, recurrent urinary tract infections, urethral stricture or bladder neck contracture.
Time Frame
3 to 6 month
Secondary Outcome Measure Information:
Title
Change of the urine flow of the patients.
Description
Improvement of the uroflowmetry parameters after catheter removal especially the Qmax (maximum flow rate), Qavg (Average flow rate) in addition to a bell shaped curve in the flowmetry plotted curve.
Time Frame
3 to 6 month
Title
Change of the IPSS (International Prostatic Symptom Score) of the patients
Description
Improvement of the IPSS score of the patients after catheter removal compared to the value of the IPSS before enucleation.
Values of the IPSS:
Mild Symptoms from 1 to 7 Moderate Symptoms from 8 to 19 Severe Symptoms from 20 to 35
Time Frame
3 to 6 month
Title
Change of residual urine volume after surgery
Description
Reduction in the amount of residual urine by US after catheter removal below 150 cc.
Time Frame
3 to 6 month
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with BPH who are unsatisfied with medical treatment having a Qmax of less than 15 cm/s.
Patients with BPH who had refractory retention.
Patients with complicated BPH (eg; chronic retention, refractory hematuria, bladder stones).
Prostate size of at least 80 grams or more.
Exclusion Criteria:
Patients with a bladder mass.
Patients with prostate cancer.
Patients suffering from a urethral stricture.
Patients with previous endoscopic or surgical prostate intervention.
Prostate size less than 80 grams.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar AbdelHamid, Msc Urology
Phone
01156626681
Email
omar-abdelaziz.a@kasralaainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Ashmawy, MD Urology
Phone
01002183223
Email
ahmdabdallah@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar AbdelRazzak, MD Urology
Organizational Affiliation
Kasr AlAiny
Official's Role
Study Director
Facility Information:
Facility Name
Kasr AlAiny School of Medicine
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nevin Soliman, MD
Phone
+202 2364 9281
Email
nsoliman@kasralainy.edu.eg
12. IPD Sharing Statement
Citations:
PubMed Identifier
6206240
Citation
Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984 Sep;132(3):474-9. doi: 10.1016/s0022-5347(17)49698-4.
Results Reference
background
PubMed Identifier
21438974
Citation
Gravas S, Bachmann A, Reich O, Roehrborn CG, Gilling PJ, De La Rosette J. Critical review of lasers in benign prostatic hyperplasia (BPH). BJU Int. 2011 Apr;107(7):1030-43. doi: 10.1111/j.1464-410X.2010.09954.x.
Results Reference
background
PubMed Identifier
29430969
Citation
Enikeev D, Glybochko P, Okhunov Z, Alyaev Y, Rapoport L, Tsarichenko D, Enikeev M, Sorokin N, Dymov A, Taratkin M. Retrospective Analysis of Short-Term Outcomes After Monopolar Versus Laser Endoscopic Enucleation of the Prostate: A Single Center Experience. J Endourol. 2018 May;32(5):417-423. doi: 10.1089/end.2017.0898. Epub 2018 Mar 13.
Results Reference
background
PubMed Identifier
26658753
Citation
Scoffone CM, Cracco CM. The en-bloc no-touch holmium laser enucleation of the prostate (HoLEP) technique. World J Urol. 2016 Aug;34(8):1175-81. doi: 10.1007/s00345-015-1741-y. Epub 2015 Dec 11.
Results Reference
background
PubMed Identifier
15735378
Citation
Fried NM, Murray KE. High-power thulium fiber laser ablation of urinary tissues at 1.94 microm. J Endourol. 2005 Jan-Feb;19(1):25-31. doi: 10.1089/end.2005.19.25.
Results Reference
background
PubMed Identifier
25518001
Citation
Hardy LA, Wilson CR, Irby PB, Fried NM. Thulium fiber laser lithotripsy in an in vitro ureter model. J Biomed Opt. 2014 Dec;19(12):128001. doi: 10.1117/1.JBO.19.12.128001.
Results Reference
background
PubMed Identifier
32441397
Citation
Ryang SH, Ly TH, Tran AV, Oh SJ, Cho SY. Bipolar enucleation of the prostate-step by step. Andrologia. 2020 Sep;52(8):e13631. doi: 10.1111/and.13631. Epub 2020 May 22.
Results Reference
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Thulium Laser Versus Bipolar Enucleation of the Prostate
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