Back to resultsEjaculation Preservation After Laser Enucleation Prostate (EPALEP)
Primary Purpose
Prostate Hyperplasia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HoLEP with median lobe preservation
HoLEP classic
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Clinique de la Sauvegarde
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
HoLEP classic
HoLEP with median lobe preservation
Arm Description
Standard HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique).
Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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
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
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
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)
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)
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)
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.
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.
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.
Urine flow (Qmax) measurement
Assessment of urine flow (Qmax) by ultrasound
Urine flow (Qmax) measurement
Assessment of urine flow (Qmax) by ultrasound
Urine flow (Qmax) measurement
Assessment of urine flow (Qmax) by ultrasound
Urine flow (Qmax) measurement
Assessment of urine flow (Qmax) by ultrasound
Adverse events related to the procedure
Presence of urinary incontinence and occurrence of adverse events related to the procedure
Assessment of resected volume / total volume
Assessment of resected volume / total volume assessed by ultrasound
Full Information
NCT ID
NCT05017285
First Posted
August 16, 2021
Last Updated
August 17, 2021
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT05017285
Brief Title
Ejaculation Preservation After Laser Enucleation Prostate
Acronym
EPALEP
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
The patient does not know which type of surgery is used
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HoLEP classic
Arm Type
Other
Arm Description
Standard HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique).
Arm Title
HoLEP with median lobe preservation
Arm Type
Experimental
Arm Description
Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum.
Intervention Type
Procedure
Intervention Name(s)
HoLEP with median lobe preservation
Intervention Description
Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum
Intervention Type
Procedure
Intervention Name(s)
HoLEP classic
Intervention Description
Standard HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique).
Primary Outcome Measure Information:
Title
Retrograde ejaculation
Description
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)
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
International Prostate Symtom Score (IPSS) assessment
Description
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
Time Frame
Month 1
Title
International Prostate Symtom Score (IPSS) assessment
Description
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
Time Frame
Month 3
Title
International Prostate Symtom Score (IPSS) assessment
Description
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
Time Frame
Month 6
Title
International Prostate Symtom Score (IPSS) assessment
Description
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
Time Frame
Month 12
Title
Men Sexual Health Questionnaire (MSHQ) score assessment
Description
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)
Time Frame
Month 3
Title
Men Sexual Health Questionnaire (MSHQ) score assessment
Description
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)
Time Frame
Month 6
Title
Men Sexual Health Questionnaire (MSHQ) score assessment
Description
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)
Time Frame
Month 12
Title
International Index of Erectil Function (IIEF-5) score assessment
Description
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.
Time Frame
Month 3
Title
International Index of Erectil Function (IIEF-5) score assessment
Description
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.
Time Frame
Month 6
Title
International Index of Erectil Function (IIEF-5) score assessment
Description
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.
Time Frame
Month 12
Title
Urine flow (Qmax) measurement
Description
Assessment of urine flow (Qmax) by ultrasound
Time Frame
Month 1
Title
Urine flow (Qmax) measurement
Description
Assessment of urine flow (Qmax) by ultrasound
Time Frame
Month 3
Title
Urine flow (Qmax) measurement
Description
Assessment of urine flow (Qmax) by ultrasound
Time Frame
Month 6
Title
Urine flow (Qmax) measurement
Description
Assessment of urine flow (Qmax) by ultrasound
Time Frame
Month 12
Title
Adverse events related to the procedure
Description
Presence of urinary incontinence and occurrence of adverse events related to the procedure
Time Frame
Month 12
Title
Assessment of resected volume / total volume
Description
Assessment of resected volume / total volume assessed by ultrasound
Time Frame
Month 12
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Study on prostate hyperplasia
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud BALDINI, MD
Phone
04-37-49-66-77
Ext
33
Email
docteur.baldini@urolyon-ouest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud BALDINI, MD PD
Organizational Affiliation
Clinique de la Sauvegarde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique de la Sauvegarde
City
Lyon
ZIP/Postal Code
69009
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud BALDINI, MD
Phone
04-37-49-66-77
Ext
33
Email
docteur.baldini@urolyon-ouest.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ejaculation Preservation After Laser Enucleation Prostate
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