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It has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (QoL). Ejaculatory dysfunction (EjD) is the most common side effect of surgical treatment of benign prostatic obstruction (BPO). It has been considered for decades to be an inevitable consequence of restoring micturition comfort. EjD can have a substantial deleterious effect on the QoL of men with previously maintained regular sexual activity, inducing decreased orgasmic intensity and increased levels of anxiety and depression. A better understanding of the physiology of ejaculation has enabled the emergence of modified surgical techniques that aim to preserve antegrade ejaculation. Our hypothesis is that conservation of ejaculation can be achieved by modified surgical procedures without compromising functional outcomes.
The aim of this study is To compare the efficacy of partial trans urethral resection of the prostate versus conventional resection of the prostate in improvement of lower urinary tract symptoms related to benign prostatic hyperplasia at 6 months. The secondary objectives are to compare the impacts of partial prostatic endoscopic surgery versus conventional endoscopic surgery on ejaculatory function, lower urinary tract symptoms, Global sexual life, Urinary flow, complication related to the surgery and the rates of re-treatment.
Investigators use a non-inferiority comparative single blinded (patient) multicenter randomized clinical trial in two parallel groups (Conventional endoscopic prostatic surgery Vs Partial surgery preserving the prostatic apex.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional endoscopic prostatic surgery | Experimental | Endoscopic resection of prostate. |
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| Partial surgery preserving the prostatic apex | Experimental | Patients randomised to the partial endoscopic resection group will undergo surgical treatment that preserves the apex area of the prostate (tissue located 1 cm around the veru montanum). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partial surgery preserving the prostatic apex | Procedure | Partial Endoscopic resection of prostate to conserve apex |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months | the mean IPSS score measured at 6 months, to compare the efficacy of partial endoscopic resection versus complete endoscopic resection in improvement of lower urinary tract symptoms related to BPH. IPSS scores are categorised as 'asymptomatic' (0 points), 'mildly symptomatic' (1-7 points), 'moderately symptomatic' (8-19 points), and 'severely symptomatic' (20-35 points). | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of ejaculation and global sexual life | MSHQ ejd= Male Sexual Health Questionnaire for Ejaculatory Dysfonction Scale score : [1-20] : a higher score mean that the subject have a ejaculatory dysfunction and sexual troubles | 1 month, 3 months, 6 months,12 months, and 36 months after surgery |
| Evaluation of lower urinary tract symptoms |
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Inclusion Criteria:
Exclusion Criteria:
Man over 40 years old
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grégoire ROBERT | Contact | 05.57.82.06.87 | gregoire.robert@chu-bordeaux.fr | |
| Méric BEN BOUJEMA | Contact | 05.57.82.06.87 | meric.ben-boujema@chu-bordeaux.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Pays d'Aix | Recruiting | Aix-en-Provence | France |
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Non inferiority Comparative single-blinded (patient) multicentre randomised clinical trial in two parallel groups:
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To prevent breaking the blinding post-operatively, the complete or partial aspect of endoscopic resection will not be mentioned in the surgical report (the patient will be specifically informed of that particular point before signing the informed consent). The complete or partial aspect of surgery will be revealed to patients at the end of follow-up, and in case of any surgical problem (e.g. need for re-intervention) or consent withdrawal.
| Conventional endoscopic prostatic surgery | Procedure | Endoscopic resection of prostate. |
|
Urinary Symptom Profile (USP) :
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| 1 month, 3 months, 6 months,12 months, and 36 months after surgery |
| Evaluation of complication rates | Complications based on Clavien Dindo classification | 1 month, 3 months, 6 months,12 months, and 36 months after surgery |
| Evaluation of ejaculation and global sexual life | IIEF-15 (including orgasmic function: questions 9 and 10), auto-questionnaire (superiority test) | 1 month, 3 months, 6 months,12 months, and 36 months after surgery |
| Evaluation of ejaculation and global sexual life | DAN PPS-SEX= Danish Prostatic Symptom Score -Sexual Questions 1A And B are question about erectyl function Questions 2A, 2B, 3A and 3B are questions about ejaculatory function Questions 4A is a question about global sexual quality of life | 1 month, 3 months, 6 months,12 months, and 36 months after surgery |
| Evaluation of lower urinary tract symptoms | IPSS = International Prostate Score Symptom Scale score [0-35]. The higher score mean that the subject have important lower urinary tract symptoms. | 1 month, 3 months, 6 months,12 months, and 36 months after surgery |
| Evaluation of lower urinary tract symptoms | Qmax (non-inferiority test) not performed at 1 month | 1 month, 3 months, 6 months,12 months, and 36 months after surgery |
| Evaluation of complication rates | Re-intervention rate | 1 month, 3 months, 6 months,12 months, and 36 months after surgery |
| CHU Angers | Recruiting | Angers | France |
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| Centre Hospitalier Universitaire de Bordeaux | Recruiting | Bordeaux | 33000 | France |
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| CHU Mondor | Withdrawn | Créteil | France |
| Hôpital Claude Huriez | Withdrawn | Lille | France |
| CHU de Limoges | Recruiting | Limoges | France |
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| Hôpital Nord Marseille | Recruiting | Marseille | France |
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| Polyclinique Saint George | Recruiting | Nice | France |
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| Hôpital cochin | Recruiting | Paris | France |
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| Hôpital Prive Francheville | Recruiting | Périgueux | France |
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| Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon Sud | Recruiting | Pierre-Bénite | France |
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| Hôpital Privé des Côtes D'Armor | Recruiting | Plérin | France |
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| CHU de Reims- Hôpital Robert Debré | Recruiting | Rennes | France |
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| CHU de Rennes | Recruiting | Rennes | France |
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| Clinique Pasteur | Withdrawn | Toulouse | France |
| CHRU Hôpitaux de tours | Withdrawn | Tours | France |
| Hopital Privé de Versailles, Clinique des Franciscaines | Recruiting | Versailles | France |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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