Ejaculation Preserving Photoselective Vaporization Versus Plasma Kinetic Vaporization Versus Transurethral Resection Of The Prostate: A RCT

Study Overview
=================
Brief Summary
-----------------
To Evaluate and compare the outcome and coast of ejaculation sparing management of BPH using 3 different techniques: PVP, PKVP and TURP. Ejaculation sparing TURP group is considered the standard control group. Evaluation will be carried out through a prospective randomized powered trial

Official Title
-----------------
Ejaculation Preserving Photoselective Vaporization Versus Plasma Kinetic Vaporization Versus Transurethral Resection Of The Prostate For Management Of Benign Prostatic Enlargement: An Objective Evaluation Through a Prospective Randomized Trial

Conditions
-----------------
Ejaculation Abnormal, BPH With Urinary Obstruction, Prostatic Hyperplasia, Prostate Disease, Prostate Obstruction

Intervention / Treatment
-----------------
* Procedure: Ejaculation Preserving Photoselective Vaporization
* Procedure: Ejaculation Preserving Plasma Kinetic Vaporization
* Procedure: Ejaculation Preserving Transurethral Resection Of The Prostate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Age >50 years 2. Prostate volume (measured by TRUS): 30-80 gm 3. International prostate symptom score (IPSS )>15 and quality of life score (QOL)< 3. 4. Maximum flow rate of uroflometry <10 ml/second 5. Patients with active sexual life (or interested) and having the ability to ejaculate and desire to preserve ejaculation. 6. Failure or intolerance to medical treatment, recurrent urinary infection, urine retention, significant hematuria or deterioration of the upper urinary tract function secondary to BOO. Exclusion Criteria: Bleeding disorders and patients on anticoagulant treatment Histologically proved cancer prostate Neurogenic voiding dysfunction Lower urinary tract malignancy Preoperative ejaculation or sexual dysfunction Presence of stricture urethra Unfit for spinal anathesia -

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Photoselective Vaporization<br> | Procedure: Ejaculation Preserving Photoselective Vaporization<br>* Ejaculation Preserving Photoselective Vaporization<br>|
| Active Comparator: Plasma Kinetic Vaporization<br> | Procedure: Ejaculation Preserving Plasma Kinetic Vaporization<br>* Ejaculation Preserving Plasma Kinetic Vaporization<br>|
| Active Comparator: Transurethral Resection Of The Prostate<br> | Procedure: Ejaculation Preserving Transurethral Resection Of The Prostate<br>* Ejaculation Preserving Transurethral Resection Of The Prostate<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimate and compare the ejaculation preservation effect of the 3 techniques (PKVP, PVP and TURP). | assessed by Male Sexual Health Questionnaire (MSHQ) | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in flow rate | measured by uroflowmetery in ml/sec | 1 years | 
| postoperative complication | measured by Clavien-Dindo Classification scale | 1 year | 
| change in patients' symptoms. | measured by International Prostate Symptom Score (I-PSS) | 1 year |