A multicentre randomised controlled trial evaluating the benefit of median lobe preservation on the incidence of retrograde ejaculation during prostate enucleation by HoLEP.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
11
Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum
Standard HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique).
Clinique de la Sauvegarde
Lyon, France
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 12
Urine flow (Qmax) measurement
Assessment of urine flow (Qmax) by ultrasound
Time frame: Month 1
Urine flow (Qmax) measurement
Assessment of urine flow (Qmax) by ultrasound
Time frame: Month 3
Urine flow (Qmax) measurement
Assessment of urine flow (Qmax) by ultrasound
Time frame: Month 6
Urine flow (Qmax) measurement
Assessment of urine flow (Qmax) by ultrasound
Time frame: Month 12
Adverse events related to the procedure
Presence of urinary incontinence and occurrence of adverse events related to the procedure
Time frame: Month 12
Assessment of resected volume / total volume
Assessment of resected volume / total volume assessed by ultrasound
Time frame: Month 12