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

Not Applicable

• Conditions: BPH With Urinary Obstruction; Ejaculation Abnormal; Prostate Disease; Prostatic Hyperplasia; Prostate Obstruction
• Interventions: Procedure: Ejaculation Preserving Photoselective Vaporization; Procedure: Ejaculation Preserving Transurethral Resection Of The Prostate; Procedure: Ejaculation Preserving Plasma Kinetic Vaporization

• Registration Number: NCT03589196
• Lead Sponsor: Mansoura University

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-03
• Study Start: 2018-03-10
• Study First Submitted: 2018-05-20
• Study First Submitted QC: 2018-07-04
• Last Update Submitted: 2018-07-04
• Study First Posted: 2018-07-17
• Last Update Posted: 2018-07-17
• Primary Completion: 2019-06-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 84

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.

  2. 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.

  3. Failure or intolerance to medical treatment, recurrent urinary infection, urine retention, significant hematuria or deterioration of the upper urinary tract function secondary to BOO.

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Exclusion Criteria

1. Bleeding disorders and patients on anticoagulant treatment
2. Histologically proved cancer prostate
3. Neurogenic voiding dysfunction
4. Lower urinary tract malignancy
5. Preoperative ejaculation or sexual dysfunction
6. Presence of stricture urethra
7. Unfit for spinal anathesia -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photoselective Vaporization	Ejaculation Preserving Photoselective Vaporization	-
Transurethral Resection Of The Prostate	Ejaculation Preserving Transurethral Resection Of The Prostate	-
Plasma Kinetic Vaporization	Ejaculation Preserving Plasma Kinetic Vaporization	-

Primary Outcome Measures

Name	Time	Method
estimate and compare the ejaculation preservation effect of the 3 techniques (PKVP, PVP and TURP).	1 years	assessed by Male Sexual Health Questionnaire (MSHQ)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Urology & Nephrology Center; 🇪🇬 Mansourah, Egypt