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

Study Overview
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Brief Summary
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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 .

Detailed Description
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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 .

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

Conditions
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Bipolar TURP , Laser Enucleation in Management of Enlarged Prostate

Intervention / Treatment
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* Device: bipolar transurethral resection and Laser enaculation by holmium: YAG laser


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |