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Prostatic Hyperplasia With Urinary ObstructionNCT03305861

Green LEP vs ThuLEP in Management of Marked Enlarged Prostate

A study testing ThuLEP and Green LEP in people with Prostatic Hyperplasia 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 The sponsor has not verified this record for over two years, so it may be out of date.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

In this study the investigators aim to test TGreenlight (532-nm) laser Photoselective Enucleation of the Prostate (Green LEP) using (XPS) 180W system ) vs Thulium Laser 200 W Enucleation of the Prostate (ThuLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in a… Read more about this study

Who is it for?
Ages 40 to 80 years, men only
What is being tested?
ThuLEP and Green LEP
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 2017to 1 Nov 2024
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 40 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients' age ≥ 40 years
  • LUTS secondary to BOO due to BPH who failed medical treatment
  • International prostate symptom scores (IPSS) >15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
  • Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
  • ASA (American society of anaesthesiologists) score ≤3.
  • TRUS prostate size > /= 80 ml

Who cannot join

  • Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
  • Active urinary tract infection,
  • Presence of active bladder cancer (within the last 2 years)
  • Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
  • Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
  • Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) except for low-dose aspirin (e.g., 100 mg).
  • Patient has had an acute myocardial infarction or open-heart surgery <180 days prior to the date of informed consent.

Trial locations and contacts

1 site in 1 country.

Mahmoud Nabil Laymon, MD contact

00201002275698

dr_mahmoudlaymon@yahoo.com

Adel M Nabeeh, Professor contact

0020100196665

adel_nabeeh51@hotmail.com

Egypt1 site, 1 recruiting
  • Urology and Nephrology Center

    Al Mansurah, Dakahlia Governorate

    Recruiting

Other trials in Egypt

About this study

Official title: GreenLight (532nm) LASER (XPS) Enucleation vs. Thulium LASER Enucleation of Prostate for Treatment of Benign Prostatic Hyperplasia

In this study the investigators aim to test TGreenlight (532-nm) laser Photoselective Enucleation of the Prostate (Green LEP) using (XPS) 180W system ) vs Thulium Laser 200 W Enucleation of the Prostate (ThuLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in a randomized controlled trial. Furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes and complications associated with the procedures will be compared.

Read the detailed description

Transurethral resection of the prostate (TURP) and open simple prostatectomy (SP) have been the historical reference-standard procedures for prostates < 80 g and ≥ 80 to 100 g, respectively, for years.

Evolution of LASER technology revived the concept of enucleation, so that the resectoscope can be used instead of the surgeon's index finger to separate the adenoma from the surgical capsule mimicking OP. There are several types of laser energy available for enucleation, but the commonest types are Holmium, Greenlight (532nm) and Thulim YAG LASERS.

Thulium: yttrium-aluminium-garnet laser Thulium LASER works at a wavelength between 1940 and 2013 nm in continuous wave mode so it offers advanced vaporization and hemostatic features. Different applications and techniques were developed ranging from vapoenucleation technique with in situ laser assisted resection, so-called Tangerine technique (Thulium Laser resection of the prostate Tangerine Technique "TmLRP-TT"), and enucleation (ThuVEP/ThuLEP are published.

Inspite of paucity of RCT comparing ThuLEP to other standard techniques in management of large prostate, long term outcomes of ThuLEP are so robust. Gross et al reported their 5 year follow up after ThuVEP in 500 patients with median prostate size of 50 grams. They demonstrated durable outcomes, with persistent reductions in I-PSS score (5 vs 21), QoL score (1 vs 4) and improvement in Q max (16.3 vs 6.9 ml/sec). Late complications included urethral stricture in 3.1%, BNC in 3.1% and recurrent adenoma in 0.6%.

Yang et al published their 5 year results of a RCT comparing ThuLEP vs TURis in 159 patients with median prostate size of 70 gm. No statistically significant difference between both groups in terms of IPSS, Qmax or post voiding residual. No patient in either group required retreatment.

In RCT by Feng et al comparing ThuLEP to PKEP ,with 18 months follow up results , the former proved to be efficient and safe within 12 months follow-up interval. However, ThuLEP had significantly better hemostasis parameters and shorter catheterization time.

III GreenLight (532nm) laser system

The Kalium-Titanyl-Phosphate (KTP) and the lithium triborate (LBO) lasers work at a wavelength of 532 nm. Laser energy is absorbed by haemoglobin, but not by water. Vaporisation leads to immediate removal of prostatic tissue, relief of BPO, and reduction of LUTS. GreenLight laser has gained increasing acceptance as a less invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH/ LUTS).

A meta-analysis of the nine available RCTs comparing PVP using the 80-W and 120-W lasers with TURP , no differences were found in Qmax and IPSS between 80-W-PVP and TURP, but only two RCTs provided sufficient 12-month data to be included in the meta-analysis.

With the 180-W (XPS) laser efficacy is comparable to TURP in terms of IPSS, Qmax, post voided residual volume, prostate volume reduction, PSA decrease and QoL questionnaires. The XPS laser prostatectomy is superior to TURP in terms of catheterisation time, lengths of hospital stay and time to stable health status.

In a RCT by Al-Ansari et al comparing HPS 120-W laser PVP versus TURP , the former was associated with dramatic improvements in all urinary outcomes compared to TURP, but reintervention rate for recurrent adenomas was 11 % compared to 1.8% in TURP group. All patients who needed redo surgery had prostate larger than 80 gm.

In another RCT, El-Shal et al of a compared Greenlight laser 180W XPS vapo enucleation , where the adenoma is bluntly enucleated partially then vaporized in situ, and HoLEP and reported 12 months follow up results. Green light XPS vapoenucleation was comparable and non inferior to HoLEP in symptom improvement. However, at 12 months Q max, prostate size reduction and PSA reduction were significantly higher in HoLEP group.

These important findings highlighted some limitations in PVP or vapoenucleation such as the difficulty in determining the anatomical cleavage limits and capsular plain of large adenomas. These drawbacks are not related to the energy source but to the technique used.

Gomez Sancha described different technique to avoid these limitations which was Greenlight LASER En-bloc Enucleation of Prostate (Green LEP) where the whole adenoma is dissected from the surgical capsule and morcellated at the end.

Misrai et al compared Green LEP vs Greenlight PVP for management of prostates larger than 80 gms. At 6 months follow up, IPSS, QoL and PVR improved similarly in both groups but Q max was significantly higher in Green LEP group. Median percent reduction in prostate size as measured by TRUS was significantly higher in green LEP (74% vs 57%). Median % reduction of PSA was 40% and 67% in PVP and Green LEP respectively (p<0.0001).

There is a paucity in studies comparing different types of EEP using different energy sources other than holmium laser.

Aim of the work In this study the investigators aim to test Thulium Laser 200 W Enucleation of the Prostate (ThuLEP) vs Greenlight (532-nm) laser Photoselective Enucleation of the Prostate (Green LEP) using (XPS) 180W system in reduction of LUTS secondary to BPH in a randomized controlled trial. Furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes and complications associated with the procedures will be compared.

Being tested
ThuLEP, Green LEP
Keywords
Thulium Laser Enucleation of the Prostate (ThuLEP), Greenlight Laser Enucleation of the Prostate (Green LEP)

What participants receive

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

  • ThuLEPProcedure or surgery

    Thulium laser enucleation of prostate

  • Green LEPProcedure or surgery

    Greenlight laser enucleation of prostate

Study groups in NCT03305861
Study groupRoleWhat they receive
ThuLEPExperimentalThulium laser enucleation of prostate
Receives: Procedure: ThuLEP
Green LEPExperimentalGreenlight laser enucleation of prostate
Receives: Procedure: Green LEP

What is being measured

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

  1. voiding and storage symptoms improvement

    International Prostate Symptom Score (I-PSS)

    Measured: 6 months

  2. sexual function changes

    International Index of Erectile Function Questionnaire (IIEF)

    Measured: 6 months

Secondary outcomes (2)
  1. Operative time

    in minutes

    Measured: 6 months

  2. Postoperative complication

    Clavien-Dindo classification for post-operative complications

    Measured: 12 months

Timeline

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

  1. First posted10 Oct 2017
  2. Study start1 Apr 2017
  3. Primary completion1 Nov 2024 (estimated)
  4. Study completion1 Nov 2024 (estimated)

Resources

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
Single blind
Who is masked
Participant
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03305861
Sponsor's protocol ID
MD/17.02.26
Status last verified
Oct 2024
First submitted
22 Sep 2017
Last updated
30 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing ThuLEP and Green LEP in people with Prostatic Hyperplasia 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 6 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 30 Oct 2024. 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?

Contact Mahmoud Nabil Laymon, MD (00201002275698, dr_mahmoudlaymon@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

voiding and storage symptoms improvement (time frame: 6 months). 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?
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 30 Oct 2024.

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