Clinical trial NCT05200065: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized study comparing two techniques of endoscopic enucleation of the prostate.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect on the operative time and other intra-operative and post-operative parameters
timeFrame: 3 to 6 month
Secondary outcomes:
measure: Change of the urine flow of the patients.
timeFrame: 3 to 6 month
measure: Change of the IPSS (International Prostatic Symptom Score) of the patients
timeFrame: 3 to 6 month
measure: Change of residual urine volume after surgery
timeFrame: 3 to 6 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr AlAiny School of Medicine
Study officials:
affiliation: Kasr AlAiny
name: Omar AbdelRazzak, MD Urology
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.