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.
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.
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
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
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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.
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
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?
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.
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?
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.