Benign Prostatic HyperplasiaNCT04471155
Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate
A study testing Holep in people with Benign Prostatic Hyperplasia, run by Ain Shams University at 1 site in Egypt.
Trial summary
comparison of holmium laser enucleation prostatectomy and open prostatectomy regarding safety and efficacy in men with prostate larger than 80 grams Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Holep
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 22 Apr 2020
- 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 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Urological Association Symptom Score of eight or higher,
- Maximum urinary flow rate of 10ml/s or less,
- Post void residual urine volume of 50 ml or more,
- And a total prostate volume of 80 ml or more in transrectal ultrasound (TRUS).
Who cannot join
- A previous prostate or urethral surgery
- And non-BPH related voiding disorders
- Prostate cancer patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate More Than 80 Grams in Egyptian Men
comparison of holmium laser enucleation prostatectomy and open prostatectomy regarding safety and efficacy in men with prostate larger than 80 grams
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Holep
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HolepProcedure or surgery
Also called open prostatectomy
laser enucleation of the gland versus open enucleation
| Study group | Role | What they receive |
|---|---|---|
| Holep | Active comparator | patient underwent laser prostatectomy Receives: Procedure: Holep |
| open prostatectomy | Active comparator | patient underwent open prostatectomy Receives: Procedure: Holep |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy by measuring maximum urinary flow rate in millilitre per second
change of maximum urinary flow rate in mililiter per second pre and post opeartive
Measured: 1 year
efficacy in american urological association symptom score
change of american urological association symptom score pre and post operative by scale from 1 to 35
Measured: 1 year
efficacy of evacuation by measuring post-voiding residual urine volume in millilitre
change of post-voiding residual urine volume in millilitre
Measured: 1 year
Secondary outcomes (1)
safety by doing blood picture to asses hemoglobin drop
rate of hemoglobin drop post-operatively by gram per decilitre
Measured: immediate post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start1 Apr 2018
- Primary completion1 Apr 2020
- Study completion22 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Model description
- randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed alnoomani, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471155
- Sponsor's protocol ID
- MD/152/2018
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate More Than 80 Grams in Egyptian Men
- ClinicalTrials.gov ID
- NCT04471155
- Acronym / sponsor ID
- MD/152/2018
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 15 Jul 2020 (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.
comparison of holmium laser enucleation prostatectomy and open prostatectomy regarding safety and efficacy in men with prostate larger than 80 grams
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Holep | Active comparator | Procedure: Holeppatient underwent laser prostatectomy |
| open prostatectomy | Active comparator | Procedure: Holeppatient underwent open prostatectomy |
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Urological Association Symptom Score of eight or higher,
- Maximum urinary flow rate of 10ml/s or less,
- Post void residual urine volume of 50 ml or more,
- And a total prostate volume of 80 ml or more in transrectal ultrasound (TRUS).
Key exclusion criteria (3 listed)
- A previous prostate or urethral surgery
- And non-BPH related voiding disorders
- Prostate cancer patients
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 |
|---|---|---|
| HolepAlso: open prostatectomylaser enucleation of the gland versus open enucleation | Procedure or surgery | Holep, open prostatectomy |
Primary outcome
efficacy by measuring maximum urinary flow rate in millilitre per second
Time frame: 1 year
change of maximum urinary flow rate in mililiter per second pre and post opeartive
efficacy in american urological association symptom score
Time frame: 1 year
change of american urological association symptom score pre and post operative by scale from 1 to 35
efficacy of evacuation by measuring post-voiding residual urine volume in millilitre
Time frame: 1 year
change of post-voiding residual urine volume in millilitre
1 secondary outcome
safety by doing blood picture to asses hemoglobin drop
Time frame: immediate post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: No
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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 Holep in people with Benign Prostatic Hyperplasia, run by Ain Shams 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 15 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
efficacy by measuring maximum urinary flow rate in millilitre per second (time frame: 1 year). The study lists 3 primary outcomes in all. 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 15 Jul 2020.