Ejaculation Preserving Photoselective Vaporization Versus... | NCT03589196

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

NCT03589196

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Jul 17, 2018Actual

Enrollment

84Estimated

Phase

Not Applicable

Conditions

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

Interventions

Ejaculation Preserving Photoselective Vaporization
Ejaculation Preserving Plasma Kinetic Vaporization
Ejaculation Preserving Transurethral Resection Of The Prostate

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2018Actual

Primary Completion Date

Jun 1, 2019Estimated

Completion Date

Dec 1, 2019Estimated

First Submitted Date

May 20, 2018

First Submission Date that Met QC Criteria

Jul 4, 2018

First Posted Date

Jul 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2018

Last Update Posted Date

Jul 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ejaculation Preserving Photoselective Vaporization	Procedure	Ejaculation Preserving Photoselective Vaporization	Photoselective Vaporization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
change in flow rate	measured by uroflowmetery in ml/sec	1 years
postoperative complication	measured by Clavien-Dindo Classification scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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 -

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Term
D011470	Prostatic Hyperplasia
D011469	Prostatic Diseases