Prostate HyperplasiaEPALEPNCT05017285
Ejaculation Preservation After Laser Enucleation Prostate
A study testing HoLEP with median lobe preservation and HoLEP classic in people with Prostate Hyperplasia, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
A multicentre randomised controlled trial evaluating the benefit of median lobe preservation on the incidence of retrograde ejaculation during prostate enucleation by HoLEP. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Hyperplasia
- What is being tested?
- HoLEP with median lobe preservation and HoLEP classic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2022to 31 Mar 2023
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40 years and older who have signed their consent to participate in the study
- Patient with preserved cognitive functions
- Patient with BPH characterised by an IPSS score ≥ 12, a Qmax ≤ 15 ml/s and an ultrasound-assessed prostate volume between 40 and 150 cc
- Patient for whom an indication for prostatic resection by HoLEP has been made,
- A patient who is sexually active and willing to maintain sexual activity after surgery
- Patient affiliated to a social security system or beneficiary of such a system
Who cannot join
- History of prostate surgery or prostate radiotherapy
- Urethral stenosis
- Cancer or a history of cancer
- Patient with a life expectancy of less than 2 years
- Patient refusing partial surgery
- History of vasectomy, erectile dysfunction or ejaculation
Show all 9Show fewer
- Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
- Patient under court protection, guardianship or curatorship
- Patient already included in another therapeutic study protocol or having participated in another trial in the previous three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Randomised Controlled Trial Evaluating the Benefit of Median Lobe Preservation on the Incidence of Retrograde Ejaculation During Prostate Enucleation by HoLEP.
A multicentre randomised controlled trial evaluating the benefit of median lobe preservation on the incidence of retrograde ejaculation during prostate enucleation by HoLEP.
Read the detailed description
The main objective of the study is to compare the incidence of retrograde ejaculation at 6 months in patients undergoing Holep surgery for prostatic adenoma according to two randomized surgical techniques: conventional surgical procedure of removal of the 3 prostatic lobes versus preservation of the median lobe.
- Conditions
- Prostate Hyperplasia
- Being tested
- HoLEP with median lobe preservation, HoLEP classic
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoLEP with median lobe preservationProcedure or surgery
Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum
HoLEP classicProcedure or surgery
Standard HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique).
| Study group | Role | What they receive |
|---|---|---|
| HoLEP classic | Other | Standard HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique). Receives: Procedure: HoLEP classic |
| HoLEP with median lobe preservation | Experimental | Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum. Receives: Procedure: HoLEP with median lobe preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrograde ejaculation
Existence of retrograde ejaculation at Month 6, as evidenced by the presence of spermatozoa in the urine following sexual intercourse (as evidenced by an ECBU performed within 24 hours of intercourse)
Measured: Month 6
Secondary outcomes (16)
International Prostate Symtom Score (IPSS) assessment
The International Prostate Symtom Score (IPSS) is a structured and validated self-administered questionnaire that assesses the intensity and discomfort of lower urinary tract disorders. It consists of 7 questions on symptomatology with answers rated from 0 to 5 and one question on quality of life. A score of <7 is mild, a score of 8-19 is moderate and a score of >20 is severe
Measured: Month 1
International Prostate Symtom Score (IPSS) assessment
The International Prostate Symtom Score (IPSS) is a structured and validated self-administered questionnaire that assesses the intensity and discomfort of lower urinary tract disorders. It consists of 7 questions on symptomatology with answers rated from 0 to 5 and one question on quality of life. A score of <7 is mild, a score of 8-19 is moderate and a score of >20 is severe
Measured: Month 3
International Prostate Symtom Score (IPSS) assessment
The International Prostate Symtom Score (IPSS) is a structured and validated self-administered questionnaire that assesses the intensity and discomfort of lower urinary tract disorders. It consists of 7 questions on symptomatology with answers rated from 0 to 5 and one question on quality of life. A score of <7 is mild, a score of 8-19 is moderate and a score of >20 is severe
Measured: Month 6
International Prostate Symtom Score (IPSS) assessment
The International Prostate Symtom Score (IPSS) is a structured and validated self-administered questionnaire that assesses the intensity and discomfort of lower urinary tract disorders. It consists of 7 questions on symptomatology with answers rated from 0 to 5 and one question on quality of life. A score of <7 is mild, a score of 8-19 is moderate and a score of >20 is severe
Measured: Month 12
Men Sexual Health Questionnaire (MSHQ) score assessment
The Men Sexual Health Questionnaire (MSHQ) assesses a patient's ability to have sex. It consists of 25 questions that explore the ability to have erections, the quality of ejaculations and the satisfaction felt during intercourse and sexual desire.
The total score (16 to 125 points maximum) is broken down into 6 sub-scores that explore erection (0 to 15 points), discomfort with erection problems (1 to 5 points), ejaculation (1 to 35 points), discomfort with ejaculation problems (1 to 5 points), satisfaction (6 to 30 points), sexual activity and desire (7 to 35 points)
Measured: Month 3
Men Sexual Health Questionnaire (MSHQ) score assessment
The Men Sexual Health Questionnaire (MSHQ) assesses a patient's ability to have sex. It consists of 25 questions that explore the ability to have erections, the quality of ejaculations and the satisfaction felt during intercourse and sexual desire.
The total score (16 to 125 points maximum) is broken down into 6 sub-scores that explore erection (0 to 15 points), discomfort with erection problems (1 to 5 points), ejaculation (1 to 35 points), discomfort with ejaculation problems (1 to 5 points), satisfaction (6 to 30 points), sexual activity and desire (7 to 35 points)
Measured: Month 6
Men Sexual Health Questionnaire (MSHQ) score assessment
The Men Sexual Health Questionnaire (MSHQ) assesses a patient's ability to have sex. It consists of 25 questions that explore the ability to have erections, the quality of ejaculations and the satisfaction felt during intercourse and sexual desire.
The total score (16 to 125 points maximum) is broken down into 6 sub-scores that explore erection (0 to 15 points), discomfort with erection problems (1 to 5 points), ejaculation (1 to 35 points), discomfort with ejaculation problems (1 to 5 points), satisfaction (6 to 30 points), sexual activity and desire (7 to 35 points)
Measured: Month 12
International Index of Erectil Function (IIEF-5) score assessment
The IIEF-5 (International Index of Erectile Function) questionnaire consists of 5 questions that assess erectile function over the past 6 months. Severe erectile dysfunction corresponds to a score of 5-10, moderate erectile dysfunction to a score of 11-15 and mild erectile dysfunction to a score of 16-20. A score of 21 to 25 corresponds to normal erectile function and scores between 1 and 4 are not interpretable.
Measured: Month 3
International Index of Erectil Function (IIEF-5) score assessment
The IIEF-5 (International Index of Erectile Function) questionnaire consists of 5 questions that assess erectile function over the past 6 months. Severe erectile dysfunction corresponds to a score of 5-10, moderate erectile dysfunction to a score of 11-15 and mild erectile dysfunction to a score of 16-20. A score of 21 to 25 corresponds to normal erectile function and scores between 1 and 4 are not interpretable.
Measured: Month 6
International Index of Erectil Function (IIEF-5) score assessment
The IIEF-5 (International Index of Erectile Function) questionnaire consists of 5 questions that assess erectile function over the past 6 months. Severe erectile dysfunction corresponds to a score of 5-10, moderate erectile dysfunction to a score of 11-15 and mild erectile dysfunction to a score of 16-20. A score of 21 to 25 corresponds to normal erectile function and scores between 1 and 4 are not interpretable.
Measured: Month 12
Urine flow (Qmax) measurement
Assessment of urine flow (Qmax) by ultrasound
Measured: Month 1
Urine flow (Qmax) measurement
Assessment of urine flow (Qmax) by ultrasound
Measured: Month 3
Urine flow (Qmax) measurement
Assessment of urine flow (Qmax) by ultrasound
Measured: Month 6
Urine flow (Qmax) measurement
Assessment of urine flow (Qmax) by ultrasound
Measured: Month 12
Adverse events related to the procedure
Presence of urinary incontinence and occurrence of adverse events related to the procedure
Measured: Month 12
Assessment of resected volume / total volume
Assessment of resected volume / total volume assessed by ultrasound
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start14 Jan 2022
- Primary completion30 Sep 2022
- Study completion31 Mar 2023
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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
- A prospective randomised multicentre single-blind comparative study of two parallel groups of patients scheduled for HoLEP prostate resection: Group 1 Conventional HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique). Group 2 Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum Each patient will be evaluated five times during the study (D0, M1, M3, M6, M12) The total duration of the study is 2 years (1 year of recruitment and 1 year of follow-up).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud BALDINI, MD PD, Principal investigator, Clinique de la Sauvegarde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017285
- Sponsor's protocol ID
- 2021-A00031-40
- Acronym
- EPALEP
- Status last verified
- Jul 2024
- First submitted
- 16 Aug 2021
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomised Controlled Trial Evaluating the Benefit of Median Lobe Preservation on the Incidence of Retrograde Ejaculation During Prostate Enucleation by HoLEP.
- ClinicalTrials.gov ID
- NCT05017285
- Acronym / sponsor ID
- EPALEP / 2021-A00031-40
- Conditions
- Prostate Hyperplasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 23 Aug 2021 (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.
A multicentre randomised controlled trial evaluating the benefit of median lobe preservation on the incidence of retrograde ejaculation during prostate enucleation by HoLEP.
Detailed description
The main objective of the study is to compare the incidence of retrograde ejaculation at 6 months in patients undergoing Holep surgery for prostatic adenoma according to two randomized surgical techniques: conventional surgical procedure of removal of the 3 prostatic lobes versus preservation of the median lobe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective randomised multicentre single-blind comparative study of two parallel groups of patients scheduled for HoLEP prostate resection: Group 1 Conventional HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique). Group 2 Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum Each patient will be evaluated five times during the study (D0, M1, M3, M6, M12) The total duration of the study is 2 years (1 year of recruitment and 1 year of follow-up).
| Arm | Type | Receives |
|---|---|---|
| HoLEP classic | Other | Procedure: HoLEP classicStandard HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique). |
| HoLEP with median lobe preservation | Experimental | Procedure: HoLEP with median lobe preservationEnucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 40 years and older who have signed their consent to participate in the study
- Patient with preserved cognitive functions
- Patient with BPH characterised by an IPSS score ≥ 12, a Qmax ≤ 15 ml/s and an ultrasound-assessed prostate volume between 40 and 150 cc
- Patient for whom an indication for prostatic resection by HoLEP has been made,
- A patient who is sexually active and willing to maintain sexual activity after surgery
Key exclusion criteria (9 listed)
- History of prostate surgery or prostate radiotherapy
- Urethral stenosis
- Cancer or a history of cancer
- Patient with a life expectancy of less than 2 years
- Patient refusing partial 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 |
|---|---|---|
| HoLEP with median lobe preservationEnucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum | Procedure or surgery | HoLEP with median lobe preservation |
| HoLEP classicStandard HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique). | Procedure or surgery | HoLEP classic |
Primary outcome
Retrograde ejaculation
Time frame: Month 6
Existence of retrograde ejaculation at Month 6, as evidenced by the presence of spermatozoa in the urine following sexual intercourse (as evidenced by an ECBU performed within 24 hours of intercourse)
16 secondary outcomes
International Prostate Symtom Score (IPSS) assessment
Time frame: Month 1
International Prostate Symtom Score (IPSS) assessment
Time frame: Month 3
International Prostate Symtom Score (IPSS) assessment
Time frame: Month 6
International Prostate Symtom Score (IPSS) assessment
Time frame: Month 12
Men Sexual Health Questionnaire (MSHQ) score assessment
Time frame: Month 3
Men Sexual Health Questionnaire (MSHQ) score assessment
Time frame: Month 6
Men Sexual Health Questionnaire (MSHQ) score assessment
Time frame: Month 12
International Index of Erectil Function (IIEF-5) score assessment
Time frame: Month 3
International Index of Erectil Function (IIEF-5) score assessment
Time frame: Month 6
International Index of Erectil Function (IIEF-5) score assessment
Time frame: Month 12
Urine flow (Qmax) measurement
Time frame: Month 1
Urine flow (Qmax) measurement
Time frame: Month 3
Urine flow (Qmax) measurement
Time frame: Month 6
Urine flow (Qmax) measurement
Time frame: Month 12
Adverse events related to the procedure
Time frame: Month 12
Assessment of resected volume / total volume
Time frame: Month 12
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- 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.
Arnaud BALDINI, MD PD principal investigator
Clinique de la Sauvegarde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HoLEP with median lobe preservation and HoLEP classic in people with Prostate Hyperplasia, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 3 Jul 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 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?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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?
Retrograde ejaculation (time frame: Month 6). 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 3 Jul 2024.