ClinicalTrials.gg
Status unknownNCT03589196EPPROSTATECTUpdated Jul 17, 2018

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

An interventional study of Ejaculation Preserving Photoselective Vaporization and Ejaculation Preserving Plasma Kinetic Vaporization in Ejaculation Abnormal, BPH With Urinary Obstruction and Prostatic Hyperplasia, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to male participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-17.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
50 Years and older
Sex
Male
01

Study 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

02

Conditions studied

  • Ejaculation Abnormal
  • BPH With Urinary Obstruction
  • Prostatic Hyperplasia
  • Prostate Disease
  • Prostate Obstruction
03

In context

Prostatic Hyperplasia

827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.

This study's planned enrollment of 84 is close to the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.

      1. 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.
      1. 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

Exclusion Criteria:

  1. Bleeding disorders and patients on anticoagulant treatment
  2. Histologically proved cancer prostate
  3. Neurogenic voiding dysfunction
  4. Lower urinary tract
  5. Preoperative ejaculation or sexual dysfunction
  6. Presence of stricture urethra
  7. Unfit for spinal anathesia -
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
84 participants (estimated)

Study arms

  • Active comparator
    Photoselective Vaporization

    Procedure: Ejaculation Preserving Photoselective Vaporization

  • Active comparator
    Plasma Kinetic Vaporization

    Procedure: Ejaculation Preserving Plasma Kinetic Vaporization

  • Active comparator
    Transurethral Resection Of The Prostate

    Procedure: Ejaculation Preserving Transurethral Resection Of The Prostate

Interventions

  • ProcedureEjaculation Preserving Photoselective Vaporization

    Ejaculation Preserving Photoselective Vaporization

  • ProcedureEjaculation Preserving Plasma Kinetic Vaporization

    Ejaculation Preserving Plasma Kinetic Vaporization

  • ProcedureEjaculation Preserving Transurethral Resection Of The Prostate

    Ejaculation Preserving Transurethral Resection Of The Prostate

06

What researchers measure

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)

    Time frame: 1 years

Secondary outcomes

  1. change in flow rate

    measured by uroflowmetery in ml/sec

    Time frame: 1 years

  2. postoperative complication

    measured by Clavien-Dindo Classification scale

    Time frame: 1 year

  3. change in patients' symptoms.

    measured by International Prostate Symptom Score (I-PSS)

    Time frame: 1 year

07

Study locations

1 site
  • Urology & Nephrology Center
    Mansourah, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03589196
Responsible party
Sponsor
First posted
Jul 17, 2018
Start date
Mar 10, 2018
Primary completion
Jun 1, 2019 (estimated)
Completion
Dec 1, 2019 (estimated)
Last update
Jul 17, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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