Thulium Laser Versus Bipolar Enucleation of the Prostate

Not Applicable

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: Bipolar enucleation of the prostate; Procedure: Thulium laser enucleation of the prostate

• Registration Number: NCT05200065
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-12-14
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-06
• Last Update Submitted: 2022-01-06
• Study First Posted: 2022-01-20
• Last Update Posted: 2022-01-20
• Primary Completion: 2022-07-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bipolar Enucleation	Bipolar enucleation of the prostate	Patients in this arm will undergo bipolar enucleation of the prostate.
Thulium Laser Enucleation	Thulium laser enucleation of the prostate	Patients in this arm will undergo thulium laser enucleation of the prostate.

Primary Outcome Measures

Name	Time	Method
Effect on the operative time and other intra-operative and post-operative parameters	3 to 6 month	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

Name	Time	Method
Change of residual urine volume after surgery	3 to 6 month	Reduction in the amount of residual urine by US after catheter removal below 150 cc.
Change of the IPSS (International Prostatic Symptom Score) of the patients	3 to 6 month	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 the urine flow of the patients.	3 to 6 month	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.

Trial Locations

Locations (1)

Kasr AlAiny School of Medicine; 🇪🇬 Cairo, Egypt