Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction

University Hospital, Bordeaux336 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

336

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Man over 40 years old * Indication of surgical management for BPH * Prostate volume ≥30 cc and ≤150 cc as evaluated by ultrasonography ( or an MRI if available) * IPSS score ≥12 * Qmax ≤15 ml/s * Affiliated to French national social security system * wish and be able to comply with planned visits * Able to express his consent * Signed informed consent form Exclusion Criteria: * Unwillingness to accept the treatment * No pre-operative ejaculation or sexuality * Neurological pathology responsible for micturition disorders * History of prostatic surgery * Stenosis of the urethra symptomatic * History of prostate cancer * History of radiotherapy or pelvic surgery * Patient refusing the principle of partial surgery * Life expectancy \<3 years * Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks. * Participation in another clinical study involving an investigational product within 1 month before study entry.

Locations (18)

CH Pays d'Aix

Aix-en-Provence, France

RECRUITING

CHU Angers

Angers, France

RECRUITING

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France

RECRUITING

CHU Mondor

Créteil, France

WITHDRAWN

Hôpital Claude Huriez

Lille, France

WITHDRAWN

CHU de Limoges

Limoges, France

RECRUITING

Hôpital Nord Marseille

Marseille, France

RECRUITING

Polyclinique Saint George

Nice, France

RECRUITING

Hôpital cochin

Paris, France

RECRUITING

Hôpital Prive Francheville

Périgueux, France

RECRUITING

...and 8 more locations

Outcomes

Primary Outcomes

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).

Time frame: 6 months after surgery

Secondary Outcomes

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