Ejaculation Preservation After Laser Enucleation Prostate

Prostate Hyperplasia Clinical Trial

— 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05017285
• Other study ID #: 2021-A00031-40
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: September 2023

Study information

• Verified date: August 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Arnaud BALDINI, MD
• Phone: 04-37-49-66-77
• Email: docteur.baldini[@]urolyon-ouest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Prostate Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• HoLEP with median lobe preservation
Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum
• HoLEP classic
Standard HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique).

Locations

Country	Name	City	State
France	Clinique de la Sauvegarde	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Month 6
Secondary	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	Month 1
Secondary	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	Month 3
Secondary	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	Month 6
Secondary	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	Month 12
Secondary	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)	Month 3
Secondary	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)	Month 6
Secondary	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)	Month 12
Secondary	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.	Month 3
Secondary	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.	Month 6
Secondary	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.	Month 12
Secondary	Urine flow (Qmax) measurement	Assessment of urine flow (Qmax) by ultrasound	Month 1
Secondary	Urine flow (Qmax) measurement	Assessment of urine flow (Qmax) by ultrasound	Month 3
Secondary	Urine flow (Qmax) measurement	Assessment of urine flow (Qmax) by ultrasound	Month 6
Secondary	Urine flow (Qmax) measurement	Assessment of urine flow (Qmax) by ultrasound	Month 12
Secondary	Adverse events related to the procedure	Presence of urinary incontinence and occurrence of adverse events related to the procedure	Month 12
Secondary	Assessment of resected volume / total volume	Assessment of resected volume / total volume assessed by ultrasound	Month 12