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

NCT03589196 | Unknown DMC

• 1 other identifier: MS/18.02.30
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• change in flow rate

  1 years

• postoperative complication

  1 year

• change in patients' symptoms.

  1 year

Study Arms (3)

Photoselective Vaporization

ACTIVE COMPARATOR

Procedure: Ejaculation Preserving Photoselective Vaporization

Plasma Kinetic Vaporization

ACTIVE COMPARATOR

Procedure: Ejaculation Preserving Plasma Kinetic Vaporization

Transurethral Resection Of The Prostate

ACTIVE COMPARATOR

Procedure: Ejaculation Preserving Transurethral Resection Of The Prostate

Interventions

Ejaculation Preserving Photoselective Vaporization PROCEDURE

Ejaculation Preserving Photoselective Vaporization

Photoselective Vaporization

Ejaculation Preserving Plasma Kinetic Vaporization PROCEDURE

Ejaculation Preserving Plasma Kinetic Vaporization

Plasma Kinetic Vaporization

Ejaculation Preserving Transurethral Resection Of The Prostate PROCEDURE

Ejaculation Preserving Transurethral Resection Of The Prostate

Transurethral Resection Of The Prostate

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology & Nephrology Center

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2018
• First Posted: July 17, 2018
• Study Start: March 10, 2018
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 17, 2018

Record last verified: 2018-03

Locations

EG (1)