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

NCT ID: NCT03589196

Last Updated: 2018-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-10

Study Completion Date

2019-12-01

Brief Summary

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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

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Conditions

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Ejaculation Abnormal BPH With Urinary Obstruction Prostatic Hyperplasia Prostate Disease Prostate Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Photoselective Vaporization

Group Type ACTIVE_COMPARATOR

Ejaculation Preserving Photoselective Vaporization

Intervention Type PROCEDURE

Ejaculation Preserving Photoselective Vaporization

Plasma Kinetic Vaporization

Group Type ACTIVE_COMPARATOR

Ejaculation Preserving Plasma Kinetic Vaporization

Intervention Type PROCEDURE

Ejaculation Preserving Plasma Kinetic Vaporization

Transurethral Resection Of The Prostate

Group Type ACTIVE_COMPARATOR

Ejaculation Preserving Transurethral Resection Of The Prostate

Intervention Type PROCEDURE

Ejaculation Preserving Transurethral Resection Of The Prostate

Interventions

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Ejaculation Preserving Photoselective Vaporization

Ejaculation Preserving Photoselective Vaporization

Intervention Type PROCEDURE

Ejaculation Preserving Plasma Kinetic Vaporization

Ejaculation Preserving Plasma Kinetic Vaporization

Intervention Type PROCEDURE

Ejaculation Preserving Transurethral Resection Of The Prostate

Ejaculation Preserving Transurethral Resection Of The Prostate

Intervention Type PROCEDURE

Eligibility Criteria

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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

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 -
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Urology & Nephrology Center

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS/18.02.30

Identifier Type: -

Identifier Source: org_study_id

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