Benign Prostatic HyperplasiaNCT05494944
Low Power ThULEP for Prostate Size More Than 80 gm
A study testing ThuLEP in people with Benign Prostatic Hyperplasia, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Feasibility and Efficacy of lower power thulium enucleation of prostate more than 80 grams Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- ThuLEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 30 Mar 2022
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- BPH patients with failed medical treatment
- Refractory retention
- Hematuria
- Bladder stones
- Renal impairment due to BPH
Who cannot join
- Neurogenic patients
- stricture urethra
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Power Thulium Enucleation of Prostate More Than 80 Grams
Feasibility and Efficacy of lower power thulium enucleation of prostate more than 80 grams
Read the detailed description
Intra operative outcome and postoperative follow up of IPSS score and IEFF score at 6 months.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- ThuLEP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThuLEPProcedure or surgery
Minimal invasive prostate intervention
| Study group | Role | What they receive |
|---|---|---|
| ThuLEP group | Other | Not described Receives: Procedure: ThuLEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing of complete adenoma removal ( enucleation time in minutes)
Measured: During operation
International prostate symptoms score IPSS less than 7 which is good outcome
Measured: 12 months
Secondary outcomes (1)
International Index of Erectile Function- 5 score more than 12 which is a good outcome
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Dec 2019
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samer Morsy, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494944
- Sponsor's protocol ID
- Urology department
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Morsy S, Kamal I, Meshref A, Abdel-Mohsen M, Abdel-Hakim M, Yehia A. Surgical outcomes of low-power thulium laser enucleation of prostates >80 g. One-year of follow-up. Cent European J Urol. 2023;76(3):193-198. doi: 10.5173/ceju.2023.50. Epub 2023 Jul 12.
PubMed 38045774
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Power Thulium Enucleation of Prostate More Than 80 Grams
- ClinicalTrials.gov ID
- NCT05494944
- Acronym / sponsor ID
- Urology department
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 10 Aug 2022 (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.
Feasibility and Efficacy of lower power thulium enucleation of prostate more than 80 grams
Detailed description
Intra operative outcome and postoperative follow up of IPSS score and IEFF score at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ThuLEP group | Other | Procedure: ThuLEP |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- BPH patients with failed medical treatment
- Refractory retention
- Hematuria
- Bladder stones
- Renal impairment due to BPH
Key exclusion criteria (2 listed)
- Neurogenic patients
- stricture urethra
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 |
|---|---|---|
| ThuLEPMinimal invasive prostate intervention | Procedure or surgery | ThuLEP group |
Primary outcome
Timing of complete adenoma removal ( enucleation time in minutes)
Time frame: During operation
International prostate symptoms score IPSS less than 7 which is good outcome
Time frame: 12 months
1 secondary outcome
International Index of Erectile Function- 5 score more than 12 which is a good outcome
Time frame: 12 months
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 12 Aug 2022.
- Derived from this study: PubMed 38045774Morsy S, Kamal I, Meshref A, Abdel-Mohsen M, Abdel-Hakim M, Yehia A. Surgical outcomes of low-power thulium laser enucleation of prostates >80 g. One-year of follow-up. Cent European J Urol. 2023;76(3):193-198. doi: 10.5173/ceju.2023.50. Epub 2023 Jul 12.
- Individual participant dataSharing planned: Undecided
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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 ThuLEP in people with Benign Prostatic Hyperplasia, run by Kasr El Aini Hospital 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 5 inclusion and 2 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 12 Aug 2022. 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?
Timing of complete adenoma removal ( enucleation time in minutes) (time frame: During operation). The study lists 2 primary outcomes in all. 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 NCT05494944, which also lists 1 linked publication.
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 12 Aug 2022.