Thulium Laser Versus Bipolar Enucleation of the Prostate

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Prospective Randomized Study Comparing the Intra-operative and Post-operative Outcomes of Bipolar Enucleation of the Prostate Versus Thulium Laser Enucleation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200065
• Other study ID #: Enucleation techniques for BPH
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: January 2022
• Source: Cairo University
• Contact: Omar AbdelHamid, Msc Urology
• Phone: 01156626681
• Email: omar-abdelaziz.a[@]kasralaainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with BPH who are unsatisfied with medical treatment having a Qmax of less than 15 cm/s.

2. Patients with BPH who had refractory retention.

3. Patients with complicated BPH (eg; chronic retention, refractory hematuria, bladder stones).

4. Prostate size of at least 80 grams or more.

Exclusion Criteria:

1. Patients with a bladder mass.

2. Patients with prostate cancer.

3. Patients suffering from a urethral stricture.

4. Patients with previous endoscopic or surgical prostate intervention.

5. Prostate size less than 80 grams.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• Thulium laser enucleation of the prostate
Using the thulium laser to achieve complete endoscopic enucleation of the prostate.
• Bipolar enucleation of the prostate
Using the bipolar plasma energy to achieve complete endoscopic enucleation of the prostate.

Locations

Country	Name	City	State
Egypt	Kasr AlAiny School of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 to 6 month
Secondary	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.	3 to 6 month
Secondary	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	3 to 6 month
Secondary	Change of residual urine volume after surgery	Reduction in the amount of residual urine by US after catheter removal below 150 cc.	3 to 6 month