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

Mansoura University

Status: Unknown

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03589196

MS/18.02.30

Details and patient eligibility

About

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

Enrollment: 84 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 3 patient groups

Photoselective Vaporization

Active Comparator group

Treatment:

Procedure: Ejaculation Preserving Photoselective Vaporization

Plasma Kinetic Vaporization

Active Comparator group

Treatment:

Procedure: Ejaculation Preserving Plasma Kinetic Vaporization

Transurethral Resection Of The Prostate

Active Comparator group

Treatment:

Procedure: Ejaculation Preserving Transurethral Resection Of The Prostate