Thulium Laser Versus Bipolar Enucleation of the Prostate

Cairo University (CU)

Status: Unknown

Conditions: Benign Prostatic Hyperplasia

Treatments: Procedure: Thulium laser enucleation of the prostate; Procedure: Bipolar enucleation of the prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT05200065

Enucleation techniques for BPH

Details and patient eligibility

About

Comparing the peri-operative outcomes in patients with benign prostatic hyperplasia (BPH) who will undergo bipolar enucleation of the prostate versus thulium laser enucleation.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Thulium Laser Enucleation

Experimental group

Description:

Patients in this arm will undergo thulium laser enucleation of the prostate.

Treatment:

Procedure: Thulium laser enucleation of the prostate

Bipolar Enucleation

Experimental group

Description:

Patients in this arm will undergo bipolar enucleation of the prostate.

Treatment:

Procedure: Bipolar enucleation of the prostate