Benign Prostate Hypertrophy(BPH)MILESNCT06839768
Safety and Efficacy of MILEP Versus Standard EEP
A study testing Standard endoscopic enucleation of the prostate (EEP) and MiLEP in people with Benign Prostate Hypertrophy(BPH) and LUTS(Lower Urinary Tract Symptoms), run by Sechenov University at 1 site in Russia.
Trial summary
Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH), LUTS(Lower Urinary Tract Symptoms)
- What is being tested?
- Standard endoscopic enucleation of the prostate (EEP) and MiLEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteRussia
- Study dates
- 14 Mar 2024to May 2025
- 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 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LUTS presence, proven by:
- IPSS questionnaire (Score >20);
- OR uroflowmetry result (Qmax <10 ml/s);
Who cannot join
- Prostate volume > 120 cc
- Prostate cancer on pathology;
- Urethral strictures;
- Bladder calculi;
- Prior prostate surgery;
- Neurogenic bladder dysfunction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Institute for Urology and Reproductive Health, Sechenov University
Moscow, 119435.
Vladislav Petov, +79253517549, pettow@mail.ru
About this study
Official title: The MILES Trial: Prospective Randomized Trial of Safety and Efficacy of Minimally-invasive Versus Standard Laser Enucleation of the Prostate
Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures.
Objective: to compare the efficacy and safety of MiLEP and standard EEP with a thulium fiber laser (TFL).
- Being tested
- Standard endoscopic enucleation of the prostate (EEP), MiLEP
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard endoscopic enucleation of the prostate (EEP)Procedure or surgery
Stabdard EEP will be nerformed using 26 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.
MiLEPProcedure or surgery
Minimally-invasive laser EEP will be nerformed using 22 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.
| Study group | Role | What they receive |
|---|---|---|
| MiLEP (22 Ch) | Experimental | Not described Receives: Procedure: MiLEP |
| EEP (26 Ch) | Active comparator | Not described Receives: Procedure: Standard endoscopic enucleation of the prostate (EEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of SUI
Measured: 1 month
Secondary outcomes (10)
Rate of urethral strictures
Measured: 6-12 months
Rate of intra- and perioperative adverse events
Assessed using Clavien-Dindo classification system
Measured: the day of operation, at 1, 6,12 months post-operative
Operative time
Measured: participants will be followed for the duration of the intervention, an expected average of 1 hour
Blood loss (blood levels of haemoglobin and haematocrit)
Measured: 1 day before and 1 day after surgery
Catheterization time
Measured: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
Hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
International Prostate Symptom Score (IPSS)
Mild LUTS (symptom score less than of equal to 7) Moderate LUTS (symptom score range 8-19) Severe LUTS (symptom score range 20-35)
Measured: 1 month
Qmax
Measured: 1 month
PVR
Measured: 1 month
International Index of Erectile Function (IIEF-5)
severe ED (5-7), moderate ED (8-11), mild to moderate ED (12-16), mild ED (17-21), and no ED (22-25)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start14 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sechenov University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Pompeia
- Responsible party
- Principal investigator, Vladislav Petov, Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839768
- Sponsor's protocol ID
- MILEP2024_0.1
- Acronym
- MILES
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 21 Feb 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 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MILES Trial: Prospective Randomized Trial of Safety and Efficacy of Minimally-invasive Versus Standard Laser Enucleation of the Prostate
- ClinicalTrials.gov ID
- NCT06839768
- Acronym / sponsor ID
- MILES / MILEP2024_0.1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Sechenov UniversityUniversity, hospital or other
- Collaborators
- Hospital Pompeia
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 21 Feb 2025 (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.
Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures.
Objective: to compare the efficacy and safety of MiLEP and standard EEP with a thulium fiber laser (TFL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MiLEP (22 Ch) | Experimental | Procedure: MiLEP |
| EEP (26 Ch) | Active comparator | Procedure: Standard endoscopic enucleation of the prostate (EEP) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IPSS questionnaire (Score >20);
- OR uroflowmetry result (Qmax <10 ml/s);
Key exclusion criteria (6 listed)
- Prostate volume > 120 cc
- Prostate cancer on pathology;
- Urethral strictures;
- Bladder calculi;
- Prior prostate surgery;
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 |
|---|---|---|
| Standard endoscopic enucleation of the prostate (EEP)Stabdard EEP will be nerformed using 26 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release. | Procedure or surgery | EEP (26 Ch) |
| MiLEPMinimally-invasive laser EEP will be nerformed using 22 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release. | Procedure or surgery | MiLEP (22 Ch) |
Primary outcome
The rate of SUI
Time frame: 1 month
10 secondary outcomes
Rate of urethral strictures
Time frame: 6-12 months
Rate of intra- and perioperative adverse events
Time frame: the day of operation, at 1, 6,12 months post-operative
Operative time
Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour
Blood loss (blood levels of haemoglobin and haematocrit)
Time frame: 1 day before and 1 day after surgery
Catheterization time
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
Hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
International Prostate Symptom Score (IPSS)
Time frame: 1 month
Qmax
Time frame: 1 month
PVR
Time frame: 1 month
International Index of Erectile Function (IIEF-5)
Time frame: 1 month
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 21 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard endoscopic enucleation of the prostate (EEP) and MiLEP in people with Benign Prostate Hypertrophy(BPH) and LUTS(Lower Urinary Tract Symptoms), run by Sechenov University at 1 site in Russia.
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 3 inclusion and 6 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 21 Feb 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 Russia. 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 Vladislav Petov, Associate Professor, urologist (+7 925 351 75 49, pettow@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of SUI (time frame: 1 month). 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 21 Feb 2025.