Benign Prostatic Hyperplasia
Conditions
Keywords
Lower Urinary Tract Symptoms, Transurethral resection of prostate, Partial Transurethral resection of prostate, quality of life, Ejaculation
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPartial surgery preserving the prostatic apex
Partial Endoscopic resection of prostate to conserve apex
PROCEDUREConventional endoscopic prostatic surgery
Endoscopic resection of prostate.
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
* The clinical research assistant will fill-out the electronic case report form (eCRF) "randomisation" page and perform the randomisation. The site will immediately provide the study identification number for the patient and the allocation group. * The clinical research assistant will print the result of the randomisation. The printed document will be placed in a sealed envelope that will be stored in the patient's file. * The surgeon will open the envelope in the operating theatre once the patient has been placed under general anaesthesia. 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.
Intervention model description
Non inferiority Comparative single-blinded (patient) multicentre randomised clinical trial in two parallel groups: * Group 1: Conventional endoscopic prostatic surgery * Group 2: Partial surgery preserving the prostatic apex
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months | 6 months after surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of ejaculation and global sexual life | 1 month, 3 months, 6 months,12 months, and 36 months after surgery | 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 |
| Evaluation of lower urinary tract symptoms | 1 month, 3 months, 6 months,12 months, and 36 months after surgery | Urinary Symptom Profile (USP) : * 1a+1b+1C \[0-9\]. A higher score mean that the subject have urinary leakage * 2+3+4+4bis+5+6+7 \[0-21\]. A higher score mean that the subject have voiding urgency * 8+9+10 \[0-9\]. A higher score mean that the subject have voiding problem |
| Evaluation of complication rates | 1 month, 3 months, 6 months,12 months, and 36 months after surgery | Complications based on Clavien Dindo classification |
Countries
France
Contacts
CONTACTGrégoire ROBERT
CONTACTMéric BEN BOUJEMA
Outcome results
None listed