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NCT03589196 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

— EPPROSTATECT  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03589196
Other study ID # MS/18.02.30
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 10, 2018
Est. completion date December 1, 2019

Study information
Verified date March 2018
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 84
Est. completion date December 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 50 Years and older
Eligibility 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 -

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ejaculation Preserving Photoselective Vaporization
Ejaculation Preserving Photoselective Vaporization
• Ejaculation Preserving Plasma Kinetic Vaporization
Ejaculation Preserving Plasma Kinetic Vaporization
• Ejaculation Preserving Transurethral Resection Of The Prostate
Ejaculation Preserving Transurethral Resection Of The Prostate

Locations
Country Name City State
Egypt Urology & Nephrology Center Mansourah

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

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