Benign Prostatic HypertrophyMOSESNCT05768776
Outpatient Holmium LASER Enucleation of the Prostate: Benefit of MOSES(TM) 2.0 Technology
An observational study of Benign Prostatic Hypertrophy and Holmium Laser Enucleation of the Prostate, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The aim of this study is to compare the success rate of outpatient surgery after holmium LASER enucleation of the prostate (HoLEP) for the treatment of BPH with and without the use of the MOSES 2.0 effect. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hypertrophy, Holmium Laser Enucleation of the Prostate
- What is being tested?
- HoLEP patients without MOSES(TM) 2.0 effect (open label) and HoLEP patients with MOSES(TM) 2.0 effect (open label)
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2023to Jul 2025
- Phase
- Observational
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: * Patients who require HoLEP for Begnign Prostate Hypertrophy eligible for outpatient management * Patients having been managed by HoLEP (without MOSES 2.0) in ambulatory care since January 2016 in the urology department of the Bordeaux University Hospital.
Who may be able to join
- Subject over 50 years old
- BPH whose symptoms require surgical management
- Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) ≥ 40g
- IPSS score > 15 and Quality of Life score ≥ 3
- Maximum urinary output (Qmax) < 15 ml/sec
Who cannot join
- Inability to read or write French
- Patients with comorbidities contraindicating general anesthesia
- Patients not eligible for outpatient care according to French recommendations (high risk of complications after general anesthesia, place of residence more than 150 km from an emergency department, alone at home the night following the intervention) .
- History of BPH surgery
- History of prostate cancer
- Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) < 40g
Show all 11Show fewer
- Existence or history of urethral stricture
- Existence or suspicion of a "neurological" bladder
- Positive preoperative cytobacteriological examination not treated appropriately
- Adult patients subject to a legal protection measure or unable to express their consent
- Patients deprived of liberty by a judicial or administrative decision or hospitalized without consent or admitted to a health or social establishment for purposes other than research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Effectiveness of the MOSES 2.0 Technology to the Non-MOSES Technology on the Success Rate of Holmium LASER Enucleation of the Prostate (HoLEP) Performed on an Outpatient Basis in the Context of Benign Prostatic Hypertrophy.
The aim of this study is to compare the success rate of outpatient surgery after holmium LASER enucleation of the prostate (HoLEP) for the treatment of BPH with and without the use of the MOSES 2.0 effect.
Read the detailed description
HoLEP is in the process of becoming the new reference surgical treatment for BPH with the main advantages over monopolar transurethral resection (TURPm) and high approach adenomectomy (AVH): the significant reduction in morbidity perioperative period and therefore the reduction in the length of hospital stay. This reduction in length of stay has led to the development of outpatient care with encouraging results. The main cause of discharge failure on D0 is the persistence of postoperative hematuria requiring maintenance of bladder irrigation. MOSESTM 2.0 technology has the advantage of better hemostasis compared to the LASER LP100 currently used. The objective of this study is to evaluate the influence of MOSESTM 2.0 technology on the outpatient success rate in patients operated on for HoLEP for BPH.
- Being tested
- HoLEP patients without MOSES(TM) 2.0 effect (open label), HoLEP patients with MOSES(TM) 2.0 effect (open label)
- Keywords
- Benign Prostatic Hypertrophy, HoLEP, MOSES(TM) 2.0, Ambulatory, Men
- Medical subject headings
- Prostatic Hyperplasia, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoLEP patients without MOSES(TM) 2.0 effect (open label)Procedure or surgery
HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, without using MOSES technology
HoLEP patients with MOSES(TM) 2.0 effect (open label)Procedure or surgery
HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, with the use of MOSES technology
| Study group | Role | What they receive |
|---|---|---|
| HoLEP patients without MOSESTM 2.0 effect (open label) | control retrospective open label Receives: Procedure: HoLEP patients without MOSES(TM) 2.0 effect (open label) | |
| HoLEP patients with MOSESTM 2.0 effect (open label) | prospective open label Receives: Procedure: HoLEP patients with MOSES(TM) 2.0 effect (open label) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient who discharge on D0 (same day of his surgery)
Measured: baseline
Number of hour's hospitalization
Measured: baseline
Secondary outcomes (13)
Number of hour's surgery time
Measured: baseline
Rate of enucleated prostate tissue By time treatment per patient
Measured: baseline
number of minutes use of the LASER during surgery
Measured: baseline
quantity of energy used during the intervention per patient
Measured: baseline
Intraoperative transfusion rate
Measured: baseline
Duration of post-operative sounding (hours)
Measured: baseline
Readmission rate within 48 hours of discharge from hospital
Measured: baseline
Mean change in IPSS before surgery and 3 months after surgery
Measured: 3 months after surgery
Mean change in QoL before surgery and 3 months after surgery
Measured: 3 months after surgery
Mean change in IIEF-5 before surgery and 3 months after surgery
Measured: 3 months after surgery
Mean change in ICIQ-short form score before surgery and 3 months after surgery
Measured: 3 months after surgery
Mean change in USP before surgery and 3 months after surgery
Measured: 3 months after surgery
Mean evolution of Qmax and post-void residual (RPM) before the intervention and at 3 months post-operative
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start28 Jun 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HypertrophyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégoire ROBERT, PU-PH, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768776
- Sponsor's protocol ID
- CHUBX2022/48
- Acronym
- MOSES
- Status last verified
- Jun 2025
- First submitted
- 3 Mar 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Effectiveness of the MOSES 2.0 Technology to the Non-MOSES Technology on the Success Rate of Holmium LASER Enucleation of the Prostate (HoLEP) Performed on an Outpatient Basis in the Context of Benign Prostatic Hypertrophy.
- ClinicalTrials.gov ID
- NCT05768776
- Acronym / sponsor ID
- MOSES / CHUBX2022/48
- Keywords
- Benign Prostatic Hypertrophy, HoLEP, MOSES(TM) 2.0, Ambulatory, Men
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 14 Mar 2023 (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.
The aim of this study is to compare the success rate of outpatient surgery after holmium LASER enucleation of the prostate (HoLEP) for the treatment of BPH with and without the use of the MOSES 2.0 effect.
Detailed description
HoLEP is in the process of becoming the new reference surgical treatment for BPH with the main advantages over monopolar transurethral resection (TURPm) and high approach adenomectomy (AVH): the significant reduction in morbidity perioperative period and therefore the reduction in the length of hospital stay. This reduction in length of stay has led to the development of outpatient care with encouraging results. The main cause of discharge failure on D0 is the persistence of postoperative hematuria requiring maintenance of bladder irrigation. MOSESTM 2.0 technology has the advantage of better hemostasis compared to the LASER LP100 currently used. The objective of this study is to evaluate the influence of MOSESTM 2.0 technology on the outpatient success rate in patients operated on for HoLEP for BPH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HoLEP patients without MOSESTM 2.0 effect (open label) | – | Procedure: HoLEP patients without MOSES(TM) 2.0 effect (open label)control retrospective open label |
| HoLEP patients with MOSESTM 2.0 effect (open label) | – | Procedure: HoLEP patients with MOSES(TM) 2.0 effect (open label)prospective open label |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients who require HoLEP for Begnign Prostate Hypertrophy eligible for outpatient management * Patients having been managed by HoLEP (without MOSES 2.0) in ambulatory care since January 2016 in the urology department of the Bordeaux University Hospital.
Key inclusion criteria (5 listed)
- Subject over 50 years old
- BPH whose symptoms require surgical management
- Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) ≥ 40g
- IPSS score > 15 and Quality of Life score ≥ 3
- Maximum urinary output (Qmax) < 15 ml/sec
Key exclusion criteria (11 listed)
- Inability to read or write French
- Patients with comorbidities contraindicating general anesthesia
- Patients not eligible for outpatient care according to French recommendations (high risk of complications after general anesthesia, place of residence more than 150 km from an emergency department, alone at home the night following the intervention) .
- History of BPH surgery
- History of prostate cancer
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 |
|---|---|---|
| HoLEP patients without MOSES(TM) 2.0 effect (open label)HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, without using MOSES technology | Procedure or surgery | HoLEP patients without MOSESTM 2.0 effect (open label) |
| HoLEP patients with MOSES(TM) 2.0 effect (open label)HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, with the use of MOSES technology | Procedure or surgery | HoLEP patients with MOSESTM 2.0 effect (open label) |
Primary outcome
Number of patient who discharge on D0 (same day of his surgery)
Time frame: baseline
Number of hour's hospitalization
Time frame: baseline
13 secondary outcomes
Number of hour's surgery time
Time frame: baseline
Rate of enucleated prostate tissue By time treatment per patient
Time frame: baseline
number of minutes use of the LASER during surgery
Time frame: baseline
quantity of energy used during the intervention per patient
Time frame: baseline
Intraoperative transfusion rate
Time frame: baseline
Duration of post-operative sounding (hours)
Time frame: baseline
Readmission rate within 48 hours of discharge from hospital
Time frame: baseline
Mean change in IPSS before surgery and 3 months after surgery
Time frame: 3 months after surgery
Mean change in QoL before surgery and 3 months after surgery
Time frame: 3 months after surgery
Mean change in IIEF-5 before surgery and 3 months after surgery
Time frame: 3 months after surgery
Mean change in ICIQ-short form score before surgery and 3 months after surgery
Time frame: 3 months after surgery
Mean change in USP before surgery and 3 months after surgery
Time frame: 3 months after surgery
Mean evolution of Qmax and post-void residual (RPM) before the intervention and at 3 months post-operative
Time frame: 3 months after surgery
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 25 Jun 2025.
- 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.
Grégoire ROBERT, PU-PH principal investigator
University Hospital Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hypertrophy and Holmium Laser Enucleation of the Prostate, run by University Hospital, Bordeaux at 1 site in France.
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 11 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. 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 France. 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?
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?
Number of patient who discharge on D0 (same day of his surgery) (time frame: baseline). 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 25 Jun 2025.