Bipolar Versus Laser Enaculation of Prostate for >80gram Prostate .

Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation.

Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications .

One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection .

Study Overview

• Status: Recruiting
• Conditions: Bipolar TURP , Laser Enucleation in Management of Enlarged Prostate
• Intervention / Treatment: Device: bipolar transurethral resection and Laser enaculation by holmium: YAG laser

Detailed Description

Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation.

Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications .

One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection , so , we try to analyze the effect of Laser enaculation of the prostate in comparison to Bipolar resection in prostate more than 80 gm .

Aim of the work:

Aim of the work is to compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.

Patients and Methods:

A randomized comparative study will be conducted at Menoufia university hospital , urology department. patients will be selected after informed consent.

Inclusion criteria: similar for all patients prostatic volume more than 80 gm , peak urinary flow rate measurement (Qmax) <15 ml/s, International Prostate Symptom Score (IPSS) of >8 , postvoid residual (PVR) <400 ml.

Exclusion criteria: Patients with prostate size less than 80gm , urethral stricture, acute urinary tract infection, repeated treatment .

Preoperatively, all the patients will undergo thorough process of history taking , clinical examination, and investigations in the form of abdominopelvic and trans rectal ultrasonography , PSA ,urine analysis, urine culture if needed and routine pre-operative lab investigations as (CBC , PT, LFTs, serum creatinine and RBS).

The treatment modality chosen for an individual will be randomized . All patients with positive urine culture will be treated by proper antibiotics before the procedures.

Peri-operatively , all patients will receive a single shot of pre-operative antibiotic.

For the first group patients transurethral resection of prostate For the second group patients Laser enaculation by holmium: YAG laser Postoperatively, patients will undergo IPSS score , flowmetry post operative after 3months .

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohamed kamal omar, MD; Phone Number: 00201066949454; Email: kimo_81eg@yahoo.com
• Study Contact Backup: Name: hossam elsaid kandeel, master; Phone Number: 00201097991198; Email: hossamkandeel016@gmail.com

Study Locations

• Egypt
  • Menoufia -
    • Shibīn Al Kawm, Menoufia -, Egypt, 12345
      • Recruiting
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- similar for all patients prostatic volume more than 80 gm , peak urinary flow rate measurement (Qmax) <15 ml/s, International Prostate Symptom Score (IPSS) of >8 , postvoid residual (PVR) <400 ml

Exclusion Criteria:

• Patients with prostate size less than 80gm , urethral stricture, acute urinary tract infection, repeated treatment .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patients prostatic volume more than 80 gm turp by bipolar resection; pt with 80gm prostate size underwent bipolar resection	Device: bipolar transurethral resection and Laser enaculation by holmium: YAG laser; Laser enaculation by holmium: YAG laser
Other: patients prostatic volume more than 80 gm turp by Laser enaculation by holmium: YAG laser; pt with 80gm prostate size underwent Laser enaculation by holmium: YAG laser	Device: bipolar transurethral resection and Laser enaculation by holmium: YAG laser; Laser enaculation by holmium: YAG laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.	compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.	1 year

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes