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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: Partial surgery preserving the prostatic apex
* Procedure: Conventional endoscopic prostatic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man over 40 years old Indication of surgical management for BPH Prostate volume ≥30 cc and ≤100 cc as evaluated by ultrasonography 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 History of prostatic arterial embolisation Stenosis of the urethra 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional endoscopic prostatic surgery<br>Endoscopic resection of prostate. | Procedure: Conventional endoscopic prostatic surgery<br>* Endoscopic resection of prostate.<br>|
| Experimental: Partial surgery preserving the prostatic apex<br>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). | Procedure: Partial surgery preserving the prostatic apex<br>* Partial Endoscopic resection of prostate to conserve apex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower Urinary Tract Symptoms, Transurethral resection of prostate, Partial Transurethral resection of prostate, quality of life, Ejaculation