Prostatic HyperplasiaNCT06565741
EEAP Using Moses 2.0 Technology vs the Thulium Fiber Laser in Medium-Large Prostates
A study testing MoLEP and ThuFLEP in people with Prostatic Hyperplasia and Surgery, run by Fundacio Puigvert at 3 sites in Spain.
Trial summary
Introduction: Endoscopic anatomical enucleation of the prostate (EEAP) with lasers has emerged as an effective and less invasive surgical option compared to traditional methods. Among the various available laser options, Holmium laser and Thulium Fiber laser have stood out as two prominent approaches for performing… Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Prostatic Hyperplasia, Surgery, Endoscopic Anatomical Enucleation of the Prostate (EEAP)
- What is being tested?
- MoLEP and ThuFLEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesSpain
- Study dates
- 3 Sep 2024to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males aged between 40 and 90 years.
- Patients who, due to their lower urinary tract symptoms, are candidates for
- BPH surgery, including:
- Obstructive urinary symptoms evaluated through IPSS with a score \>7 and QoL \> 2 or acute urinary reten on refractory to catheter removal.
- Obstructive urinary flow evaluated through uroflowmetry with Qmax\< 15 ml/s, obstruction demonstrated by pressure/flow study, prostatic origin haematuria refractory to medical treatment, or acute urinary retention refractory to catheter removal.
- Prostatic volume measured by transabdominal ultrasound, transrectal ultrasound, or magnetic resonance imaging of more than 80 cc.
- Prostate-specific antigen (PSA) \< 4 ng/ml, or with multiparametric prostate magnetic resonance imaging reporting PIRADS \< 3 or equal to 3 with PSA density \< 15%.
Who cannot join
- Diagnosis, suspicion, or history of urethral stenosis or urethral surgery.
- History of prostate surgery or pelvic radiotherapy.
- Diagnosis or suspicion of prostate cancer or urothelial cancer.
- Body mass index superior to 30.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Fundacio Puigvert
Barcelona, BARCELONA, 08025
Ivan Schwartzmann Jochamowitz, MD, 0034934169700 ext. 4608, ischwartzm@fundacio-puigvert.es
Silvia Mateu, MD, 934169700 ext. 4602, smateu@fundacio-puigvert.es
- Recruiting
Clinic Hospital of Barcelona
Barcelona, BARCELONA, 08036
Maurizio d'Anna, MD, 0034 93 227 54 00, danna@clinic.cat
Javier Sanchez Macià, MD, 0034 93 227 54 00
- Recruiting
Hospital Univesitari de Bellvitge
L'Hospitalet de Llobregat, BARCELONA, 08907
Sergi Beato, MD, 0034 932 60 75 00
Andreu Alabat, MD, 0034 932 60 75 00
About this study
Official title: Prospective and Randomized Analysis of Endoscopic Prostate Enucleation Using Moses 2.0 Technology Versus the New Thulium Fiber Laser in Medium and Large Prostates.
Introduction: Endoscopic anatomical enucleation of the prostate (EEAP) with lasers has emerged as an effective and less invasive surgical option compared to traditional methods. Among the various available laser options, Holmium laser and Thulium Fiber laser have stood out as two prominent approaches for performing endoscopic prostate enucleation. These technologies have 3 showcased their effectiveness in ablating prostatic tissue and improving urinary symptoms. Nevertheless, differences in their physical properties and modes of action may impact their success rates and clinical outcomes. In our institution it is standard practice to use one laser or the other according to their availability in the operating room.
Primary Objective: To demonstrate the superiority of MoLEP over ThuFLEP in terms of enucleation efficiency.
Read more
Secondary Objectives: a) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of perioperative bleeding.
- To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of postoperative hospital stay.
- To demonstrate the non-inferiority of ThuFLEP compared to ThuFLEP in terms of perioperative complications.
- To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in urinary symptoms.
- To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in flowmetric variables.
Study Type: Prospective, randomized, non-blind, multicentric clinical trial. Intervention: Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.
Read the detailed description
Surgery and Follow-up Schedule
- Surgeries will be performed between September 2024 and September 2025.
- Initial follow-up at 3 months.
- Completion of the first phase of the study: March 2026.
Scheduled of Visits: Selection Visit, 1-Month Postoperative Visit, 3-Month Follow-up, 6-Month Follow-up, Annual Follow-up Visit (1-3 years).
Sample size calculation was done using the main outcome variable (total surgical time). Previous studies indicate that surgical time for ThuFLEP is 71.6 minutes [8]. The time for MoLEP may be at least 5 minutes less. Accepting an alpha risk of 5% and a beta risk of 20% in a two-tailed test, a total of 120 patients are needed (60 in each study group). A common standard deviation of 9 minutes change is assumed. A loss to follow-up rate of 15% has been estimated.
Randomization between the two surgery groups will be performed using the Efron procedure to balance the groups in terms of the number of subjects. The calculation will be carried out with the !RndSeq macro for SPSS Statistics. It will be conducted centrally by a person independent of the surgeon.
Statistical Analysis: For quantitative variables, measures of central tendency and dispersion will be .provided. Normality tests will be conducted using the Shapiro-Wilk test. For qualitative variables, valid percentages will be shown. Sociodemographic and clinical data, as well as the main study variables, will be compared between study groups using the Student's t-test (Mann-Whitney U test in case of non-normality). Chi-square test or Fisher's test (if any observed frequency is <5) will be used for qualitative variables. A multivariate linear regression model will be constructed to determine variables related to surgical time. Beta coefficients and 95% confidence intervals (CI) will be determined. A preliminary study will be conducted on potential confounding and interacting factors. Adjustment will be made for clinically or bibliographically relevant variables. Interaction will be tested using the likelihood ratio test. A significant difference will be accepted in all tests with a p-value <0.05. R Studio statistical package (V2.5.1) will be used for data analysis.
- Being tested
- MoLEP, ThuFLEP
- Keywords
- Medium and Large Prostates, Endoscopic Prostate Enucleation, Endoscopic anatomical enucleation of the prostate (EEAP), Holmium laser, Thulium Fiber laser, Moses 2.0 Technology
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoLEPProcedure or surgery
Also called Moses 2.0 Technology
Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.
ThuFLEPProcedure or surgery
Also called New Thulium Fiber Laser
Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Prostate Enucleation Using Moses 2.0 Technology | Active comparator | Pulse modulation technology in Moses 2.0 applied to Holmium Laser Endoscopic Prostate (MoLEP). Receives: Procedure: MoLEP |
| Endoscopic Prostate Enucleation Using the New Thulium Fiber Laser | Active comparator | Thulium Fiber laser to endoscopic prostate enucleation (ThuFLEP). Receives: Procedure: ThuFLEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
SURGICAL TIME
Difference in surgical time between MoLEP and ThuFLEP in prostates larger than 80 cc.
Measured: Total time of Surgery procedure
Secondary outcomes (7)
Perioperative bleeding
Differences in perioperative bleeding between MoLEP and ThuFLEP. Difference in haemoglobin level between preoperative blood test and control blood test postoperatively within 24 hours after surgery).
Measured: From date of preoperative blood test to date of control blood test postoperatively within 24 hours after surgery
Postoperative hospital stay
Difference in postoperative hospital stay time between MoLEP and ThuFLEP. Number of days of hospitalization after surgery. Three categories will be recorded: Ambulatory (<16 hours of stay), Less than 24 hours, More than 24 hours (individual length of stay will be recorded).
Measured: From date and time of end of surgery to date and time of hospital discharge assessed up to 1 month
Perioperative complications
Difference in the incidence of perioperative complications between MoLEP and ThuFLEP. All possible complications will be recorded and classified according to the Clavien- Dindo scale from date of surgery to end of study.
Measured: From date of surgery to date of the end of follow-up 3 years
Urinary symptoms
Difference in improvement of urinary symptoms after MoLEP compared to ThuFLEP. IPSS questionnaire will be performed in all study visits: Changes in total score and quality of life score before and after surgery will be compared between patients undergoing MoLEP and ThuFLEP.
Measured: From date of enrollment to date of the end of follow-up 3 years
Flowmetric variables maximum flow
Difference in improvement of flowmetric values after MoLEP compared to ThuFLEP. Uroflowmetry will be performed at baseline, 3 months, 6 months and annual follow-up visits: Changes in maximum flow measured in ml/s before and after surgery will be compared between patients undergoing MoLEP and ThuFLEP.
A uroflowmetry will be considered valid if the patient reports that it is representative of their current voiding quality and if it presents a voided volume > 150 ml.
Measured: From date of surgery to date of the end of follow-up 3 years
Flowmetric variables average flow
Difference in improvement of flowmetric values after MoLEP compared to ThuFLEP. Uroflowmetry will be performed at baseline, 3 months, 6 months and annual follow-up visits: Changes in average flow measured in ml/s before and after surgery will be compared between patients undergoing MoLEP and ThuFLEP.
A uroflowmetry will be considered valid if the patient reports that it is representative of their current voiding quality and if it presents a voided volume > 150 ml.
Measured: From date of surgery to date of the end of follow-up 3 years
Flowmetric variables post-void residual
Difference in improvement of flowmetric values after MoLEP compared to ThuFLEP. Uroflowmetry will be performed at baseline, 3 months, 6 months and annual follow-up visits: Changes in post-void residual measured in ml before and after surgery will be compared between patients undergoing MoLEP and ThuFLEP.
A uroflowmetry will be considered valid if the patient reports that it is representative of their current voiding quality and if it presents a voided volume > 150 ml.
Measured: From date of surgery to date of the end of follow-up 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start3 Sep 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio Puigvert
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Schwartzmann, MD, Fundacio Puigvert
- Investigators
- Ivan Schwartzmann Jochamowitz, MD, Principal investigator, Fundacio Puigvert
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565741
- Sponsor's protocol ID
- C-2024-23
- Status last verified
- Apr 2026
- First submitted
- 13 Aug 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A total of two publications with study results will be made, each differing in the follow-up time. A publication of preliminary results will be made when the last patient included in the study has completed the three-month follow-up. A second publication will be made when the last included patient completes two years of follow-up.
Publications
Enikeev D, Glybochko P, Okhunov Z, Alyaev Y, Rapoport L, Tsarichenko D, Enikeev M, Sorokin N, Dymov A, Taratkin M. Retrospective Analysis of Short-Term Outcomes After Monopolar Versus Laser Endoscopic Enucleation of the Prostate: A Single Center Experience. J Endourol. 2018 May;32(5):417-423. doi: 10.1089/end.2017.0898. Epub 2018 Mar 13.
PubMed 29430969Nottingham CU, Large T, Agarwal DK, Rivera ME, Krambeck AE. Comparison of Newly Optimized Moses Technology vs Standard Holmium:YAG for Endoscopic Laser Enucleation of the Prostate. J Endourol. 2021 Sep;35(9):1393-1399. doi: 10.1089/end.2020.0996. Epub 2021 Jul 15.
PubMed 33813861Wani MM, Sriprasad S, Bhat T, Madaan S. Is Thulium laser enucleation of prostate an alternative to Holmium and TURP surgeries - A systematic review? Turk J Urol. 2020 Nov;46(6):419-426. doi: 10.5152/tud.2020.20202. Epub 2020 Oct 9.
PubMed 33052829Fraundorfer MR, Gilling PJ. Holmium:YAG laser enucleation of the prostate combined with mechanical morcellation: preliminary results. Eur Urol. 1998;33(1):69-72. doi: 10.1159/000019535.
PubMed 9471043Elmansy H, Hodhod A, Elshafei A, Noureldin YA, Mehrnoush V, Zakaria AS, Hadi RA, Fathy M, Abbas L, Kotb A, Shahrour W. Comparative analysis of MOSESTM technology versus novel thulium fiber laser (TFL) for transurethral enucleation of the prostate: A single-institutional study. Arch Ital Urol Androl. 2022 Jun 29;94(2):180-185. doi: 10.4081/aiua.2022.2.180.
PubMed 35775343Zhang Y, Yuan P, Ma D, Gao X, Wei C, Liu Z, Li R, Wang S, Liu J, Liu X. Efficacy and safety of enucleation vs. resection of prostate for treatment of benign prostatic hyperplasia: a meta-analysis of randomized controlled trials. Prostate Cancer Prostatic Dis. 2019 Dec;22(4):493-508. doi: 10.1038/s41391-019-0135-4. Epub 2019 Feb 28.
PubMed 30816336Enikeev D, Netsch C, Rapoport L, Gazimiev M, Laukhtina E, Snurnitsyna O, Alekseeva T, Becker B, Taratkin M, Glybochko P. Novel thulium fiber laser for endoscopic enucleation of the prostate: A prospective comparison with conventional transurethral resection of the prostate. Int J Urol. 2019 Dec;26(12):1138-1143. doi: 10.1111/iju.14115. Epub 2019 Sep 22.
PubMed 31544290
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Randomized Analysis of Endoscopic Prostate Enucleation Using Moses 2.0 Technology Versus the New Thulium Fiber Laser in Medium and Large Prostates.
- ClinicalTrials.gov ID
- NCT06565741
- Acronym / sponsor ID
- C-2024-23
- Keywords
- Medium and Large Prostates, Endoscopic Prostate Enucleation, Endoscopic anatomical enucleation of the prostate (EEAP), Holmium laser, Thulium Fiber laser, Moses 2.0 Technology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundacio PuigvertUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 22 Aug 2024 (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.
Introduction: Endoscopic anatomical enucleation of the prostate (EEAP) with lasers has emerged as an effective and less invasive surgical option compared to traditional methods. Among the various available laser options, Holmium laser and Thulium Fiber laser have stood out as two prominent approaches for performing endoscopic prostate enucleation. These technologies have 3 showcased their effectiveness in ablating prostatic tissue and improving urinary symptoms. Nevertheless, differences in their physical properties and modes of action may impact their success rates and clinical outcomes. In our institution it is standard practice to use one laser or the other according to their availability in the operating room.
Primary Objective: To demonstrate the superiority of MoLEP over ThuFLEP in terms of enucleation efficiency.
Secondary Objectives: a) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of perioperative bleeding.
- To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of postoperative hospital stay.
- To demonstrate the non-inferiority of ThuFLEP compared to ThuFLEP in terms of perioperative complications.
- To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in urinary symptoms.
- To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in flowmetric variables.
Study Type: Prospective, randomized, non-blind, multicentric clinical trial. Intervention: Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.
Detailed description
Surgery and Follow-up Schedule
- Surgeries will be performed between September 2024 and September 2025.
- Initial follow-up at 3 months.
- Completion of the first phase of the study: March 2026.
Scheduled of Visits: Selection Visit, 1-Month Postoperative Visit, 3-Month Follow-up, 6-Month Follow-up, Annual Follow-up Visit (1-3 years).
Sample size calculation was done using the main outcome variable (total surgical time). Previous studies indicate that surgical time for ThuFLEP is 71.6 minutes [8]. The time for MoLEP may be at least 5 minutes less. Accepting an alpha risk of 5% and a beta risk of 20% in a two-tailed test, a total of 120 patients are needed (60 in each study group). A common standard deviation of 9 minutes change is assumed. A loss to follow-up rate of 15% has been estimated.
Randomization between the two surgery groups will be performed using the Efron procedure to balance the groups in terms of the number of subjects. The calculation will be carried out with the !RndSeq macro for SPSS Statistics. It will be conducted centrally by a person independent of the surgeon.
Statistical Analysis: For quantitative variables, measures of central tendency and dispersion will be .provided. Normality tests will be conducted using the Shapiro-Wilk test. For qualitative variables, valid percentages will be shown. Sociodemographic and clinical data, as well as the main study variables, will be compared between study groups using the Student's t-test (Mann-Whitney U test in case of non-normality). Chi-square test or Fisher's test (if any observed frequency is <5) will be used for qualitative variables. A multivariate linear regression model will be constructed to determine variables related to surgical time. Beta coefficients and 95% confidence intervals (CI) will be determined. A preliminary study will be conducted on potential confounding and interacting factors. Adjustment will be made for clinically or bibliographically relevant variables. Interaction will be tested using the likelihood ratio test. A significant difference will be accepted in all tests with a p-value <0.05. R Studio statistical package (V2.5.1) will be used for data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP.
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Prostate Enucleation Using Moses 2.0 Technology | Active comparator | Procedure: MoLEPPulse modulation technology in Moses 2.0 applied to Holmium Laser Endoscopic Prostate (MoLEP). |
| Endoscopic Prostate Enucleation Using the New Thulium Fiber Laser | Active comparator | Procedure: ThuFLEPThulium Fiber laser to endoscopic prostate enucleation (ThuFLEP). |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males aged between 40 and 90 years.
- Patients who, due to their lower urinary tract symptoms, are candidates for
- Obstructive urinary symptoms evaluated through IPSS with a score \>7 and QoL \> 2 or acute urinary reten on refractory to catheter removal.
- Obstructive urinary flow evaluated through uroflowmetry with Qmax\< 15 ml/s, obstruction demonstrated by pressure/flow study, prostatic origin haematuria refractory to medical treatment, or acute urinary retention refractory to catheter removal.
Key exclusion criteria (4 listed)
- Diagnosis, suspicion, or history of urethral stenosis or urethral surgery.
- History of prostate surgery or pelvic radiotherapy.
- Diagnosis or suspicion of prostate cancer or urothelial cancer.
- Body mass index superior to 30.
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 |
|---|---|---|
| MoLEPAlso: Moses 2.0 TechnologyPatients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure. | Procedure or surgery | Endoscopic Prostate Enucleation Using Moses 2.0 Technology |
| ThuFLEPAlso: New Thulium Fiber LaserPatients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure. | Procedure or surgery | Endoscopic Prostate Enucleation Using the New Thulium Fiber Laser |
Primary outcome
SURGICAL TIME
Time frame: Total time of Surgery procedure
Difference in surgical time between MoLEP and ThuFLEP in prostates larger than 80 cc.
7 secondary outcomes
Perioperative bleeding
Time frame: From date of preoperative blood test to date of control blood test postoperatively within 24 hours after surgery
Postoperative hospital stay
Time frame: From date and time of end of surgery to date and time of hospital discharge assessed up to 1 month
Perioperative complications
Time frame: From date of surgery to date of the end of follow-up 3 years
Urinary symptoms
Time frame: From date of enrollment to date of the end of follow-up 3 years
Flowmetric variables maximum flow
Time frame: From date of surgery to date of the end of follow-up 3 years
Flowmetric variables average flow
Time frame: From date of surgery to date of the end of follow-up 3 years
Flowmetric variables post-void residual
Time frame: From date of surgery to date of the end of follow-up 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 29430969Enikeev D, Glybochko P, Okhunov Z, Alyaev Y, Rapoport L, Tsarichenko D, Enikeev M, Sorokin N, Dymov A, Taratkin M. Retrospective Analysis of Short-Term Outcomes After Monopolar Versus Laser Endoscopic Enucleation of the Prostate: A Single Center Experience. J Endourol. 2018 May;32(5):417-423. doi: 10.1089/end.2017.0898. Epub 2018 Mar 13.
- Background: PubMed 33813861Nottingham CU, Large T, Agarwal DK, Rivera ME, Krambeck AE. Comparison of Newly Optimized Moses Technology vs Standard Holmium:YAG for Endoscopic Laser Enucleation of the Prostate. J Endourol. 2021 Sep;35(9):1393-1399. doi: 10.1089/end.2020.0996. Epub 2021 Jul 15.
- Background: PubMed 33052829Wani MM, Sriprasad S, Bhat T, Madaan S. Is Thulium laser enucleation of prostate an alternative to Holmium and TURP surgeries - A systematic review? Turk J Urol. 2020 Nov;46(6):419-426. doi: 10.5152/tud.2020.20202. Epub 2020 Oct 9.
- Background: PubMed 9471043Fraundorfer MR, Gilling PJ. Holmium:YAG laser enucleation of the prostate combined with mechanical morcellation: preliminary results. Eur Urol. 1998;33(1):69-72. doi: 10.1159/000019535.
- Background: PubMed 35775343Elmansy H, Hodhod A, Elshafei A, Noureldin YA, Mehrnoush V, Zakaria AS, Hadi RA, Fathy M, Abbas L, Kotb A, Shahrour W. Comparative analysis of MOSESTM technology versus novel thulium fiber laser (TFL) for transurethral enucleation of the prostate: A single-institutional study. Arch Ital Urol Androl. 2022 Jun 29;94(2):180-185. doi: 10.4081/aiua.2022.2.180.
- Background: PubMed 30816336Zhang Y, Yuan P, Ma D, Gao X, Wei C, Liu Z, Li R, Wang S, Liu J, Liu X. Efficacy and safety of enucleation vs. resection of prostate for treatment of benign prostatic hyperplasia: a meta-analysis of randomized controlled trials. Prostate Cancer Prostatic Dis. 2019 Dec;22(4):493-508. doi: 10.1038/s41391-019-0135-4. Epub 2019 Feb 28.
- Background: PubMed 31544290Enikeev D, Netsch C, Rapoport L, Gazimiev M, Laukhtina E, Snurnitsyna O, Alekseeva T, Becker B, Taratkin M, Glybochko P. Novel thulium fiber laser for endoscopic enucleation of the prostate: A prospective comparison with conventional transurethral resection of the prostate. Int J Urol. 2019 Dec;26(12):1138-1143. doi: 10.1111/iju.14115. Epub 2019 Sep 22.
- Individual participant dataSharing planned: Yes. A total of two publications with study results will be made, each differing in the follow-up time. A publication of preliminary results will be made when the last patient included in the study has completed the three-month follow-up. A second publication will be made when the last included patient completes two years of follow-up.
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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.
Ivan Schwartzmann Jochamowitz, MD principal investigator
Fundacio Puigvert
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoLEP and ThuFLEP in people with Prostatic Hyperplasia and Surgery, run by Fundacio Puigvert at 3 sites in Spain.
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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Schwartzmann Jochamowitz, MD (0034934169700 ext. 4608, ischwartzm@fundacio-puigvert.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SURGICAL TIME (time frame: Total time of Surgery procedure). 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 NCT06565741, which also lists 7 linked publications.
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 29 Apr 2026.