Ejaculation AbnormalEPPROSTATECTNCT03589196

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

A study testing Ejaculation Preserving Photoselective Vaporization, Ejaculation Preserving Plasma Kinetic Vaporization and Ejaculation Preserving Transurethral Resection Of The Prostate in people with Ejaculation Abnormal and BPH With Urinary Obstruction, run by Mansoura University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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 Read more about this study

Who is it for?: Ages 50 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Ejaculation Abnormal, BPH With Urinary Obstruction, Prostatic Hyperplasia
What is being tested?: Ejaculation Preserving Photoselective Vaporization, Ejaculation Preserving Plasma Kinetic Vaporization and Ejaculation Preserving Transurethral Resection Of The Prostate
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteEgypt
Study dates: 10 Mar 2018to 1 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 -

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Urology & Nephrology Center
Al Mansurah

Other trials in Egypt

About this study

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

Conditions: Ejaculation Abnormal, BPH With Urinary Obstruction, Prostatic Hyperplasia, Prostate Disease, Prostate Obstruction
Being tested: Ejaculation Preserving Photoselective Vaporization, Ejaculation Preserving Plasma Kinetic Vaporization, Ejaculation Preserving Transurethral Resection Of The Prostate
Medical subject headings: Prostatic Hyperplasia, Prostatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ejaculation Preserving Photoselective VaporizationProcedure or surgery
Ejaculation Preserving Photoselective Vaporization
Ejaculation Preserving Plasma Kinetic VaporizationProcedure or surgery
Ejaculation Preserving Plasma Kinetic Vaporization
Ejaculation Preserving Transurethral Resection Of The ProstateProcedure or surgery
Ejaculation Preserving Transurethral Resection Of The Prostate

Study groups in NCT03589196
Study group	Role	What they receive
Photoselective Vaporization	Active comparator	Not described Receives: Procedure: Ejaculation Preserving Photoselective Vaporization
Plasma Kinetic Vaporization	Active comparator	Not described Receives: Procedure: Ejaculation Preserving Plasma Kinetic Vaporization
Transurethral Resection Of The Prostate	Active comparator	Not described Receives: Procedure: Ejaculation Preserving Transurethral Resection Of The Prostate

What is being measured

The primary outcome is the main question the study is designed to answer.

estimate and compare the ejaculation preservation effect of the 3 techniques (PKVP, PVP and TURP).
assessed by Male Sexual Health Questionnaire (MSHQ)
Measured: 1 years

Secondary outcomes (3)

change in flow rate
measured by uroflowmetery in ml/sec
Measured: 1 years
postoperative complication
measured by Clavien-Dindo Classification scale
Measured: 1 year
change in patients' symptoms.
measured by International Prostate Symptom Score (I-PSS)
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 20181 Dec 2019

First posted17 Jul 2018
Study start10 Mar 2018
Primary completion1 Jun 2019 (estimated)
Study completion1 Dec 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ejaculation AbnormalStudies of the same condition, open and under way.
More trials run by Mansoura UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03589196
Sponsor's protocol ID: MS/18.02.30
Acronym: EPPROSTATECT
Status last verified: Mar 2018
First submitted: 20 May 2018
Last updated: 17 Jul 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03589196
Acronym / sponsor ID: EPPROSTATECT / MS/18.02.30
Conditions: Ejaculation Abnormal, BPH With Urinary Obstruction, Prostatic Hyperplasia, Prostate Disease, Prostate Obstruction
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 84 participants (estimated)
Lead sponsor: Mansoura UniversityUniversity, hospital or other
Study start: 10 Mar 2018 (actual)
Primary completion: 1 Jun 2019 (estimated)
Study completion: 1 Dec 2019 (estimated)
First posted: 17 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (7 listed)

Bleeding disorders and patients on anticoagulant treatment
Histologically proved cancer prostate
Neurogenic voiding dysfunction
Lower urinary tract malignancy
Preoperative ejaculation or sexual dysfunction

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ejaculation Preserving Photoselective VaporizationEjaculation Preserving Photoselective Vaporization	Procedure or surgery	Photoselective Vaporization
Ejaculation Preserving Plasma Kinetic VaporizationEjaculation Preserving Plasma Kinetic Vaporization	Procedure or surgery	Plasma Kinetic Vaporization
Ejaculation Preserving Transurethral Resection Of The ProstateEjaculation Preserving Transurethral Resection Of The Prostate	Procedure or surgery	Transurethral Resection Of The Prostate

Primary outcome

estimate and compare the ejaculation preservation effect of the 3 techniques (PKVP, PVP and TURP).
Time frame: 1 years
assessed by Male Sexual Health Questionnaire (MSHQ)

3 secondary outcomes

change in flow rate
Time frame: 1 years
postoperative complication
Time frame: 1 year
change in patients' symptoms.
Time frame: 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

estimate and compare the ejaculation preservation effect of the 3 techniques (PKVP, PVP and TURP). (time frame: 1 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03589196.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.