Thulium Laser Versus Bipolar Enucleation of the Prostate

NCT05200065 | Unknown

• 1 other identifier: Enucleation techniques for BPH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of the urine flow of the patients.

  3 to 6 month

• Change of the IPSS (International Prostatic Symptom Score) of the patients

  3 to 6 month

• Change of residual urine volume after surgery

  3 to 6 month

Study Arms (2)

Thulium Laser Enucleation

EXPERIMENTAL

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

Procedure: Thulium laser enucleation of the prostate

Bipolar Enucleation

EXPERIMENTAL

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

Procedure: Bipolar enucleation of the prostate

Interventions

Thulium laser enucleation of the prostate PROCEDURE

Using the thulium laser to achieve complete endoscopic enucleation of the prostate.

Thulium Laser Enucleation

Bipolar enucleation of the prostate PROCEDURE

Using the bipolar plasma energy to achieve complete endoscopic enucleation of the prostate.

Bipolar Enucleation

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr AlAiny School of Medicine

Cairo, 11562, Egypt

RECRUITING

Related 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. doi: 10.1016/s0022-5347(17)49698-4.

  PMID: 6206240 BACKGROUND

• 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.

  PMID: 21438974 BACKGROUND

• 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.

  PMID: 29430969 BACKGROUND

• 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.

  PMID: 26658753 BACKGROUND

• 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.

  PMID: 15735378 BACKGROUND

• 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.

  PMID: 25518001 BACKGROUND

• 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.

  PMID: 32441397 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Omar AbdelRazzak, MD Urology

  Kasr AlAiny

  STUDY DIRECTOR

Central Study Contacts

Omar AbdelHamid, Msc Urology

CONTACT

01156626681; omar-abdelaziz.a@kasralaainy.edu.eg

Ahmed Ashmawy, MD Urology

CONTACT

01002183223; ahmdabdallah@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Prospective randomized study comparing the two techniques with patient allocation using computer generated randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Urology Cairo University

Model Details: Prospective randomized study comparing two techniques of endoscopic enucleation of the prostate.

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 20, 2022
• Study Start: January 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: October 31, 2022
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

EG (1)