Clinical trial NCT05574244: 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
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Lower Urinary Tract Symptoms
Transurethral resection of prostate
Partial Transurethral resection of prostate
quality of life
Ejaculation
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 336
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Evaluation of ejaculation and global sexual life
timeFrame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
measure: Evaluation of lower urinary tract symptoms
timeFrame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
measure: Evaluation of complication rates
timeFrame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
measure: Evaluation of ejaculation and global sexual life
timeFrame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
measure: Evaluation of ejaculation and global sexual life
timeFrame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
measure: Evaluation of lower urinary tract symptoms
timeFrame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
measure: Evaluation of lower urinary tract symptoms
timeFrame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
measure: Evaluation of complication rates
timeFrame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: CH Pays d'Aix
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Créteil
country: France
facility: CHU Mondor
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Limoges
country: France
facility: CHU de Limoges
city: Marseille
country: France
facility: Hôpital Nord Marseille
city: Nice
country: France
facility: Polyclinique Saint George
city: Paris
country: France
facility: Hôpital cochin
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon Sud
city: Plérin
country: France
facility: Hôpital Privé des Côtes D'Armor
city: Périgueux
country: France
facility: Hôpital Prive Francheville
city: Rennes
country: France
facility: CHU de Reims- Hôpital Robert Debré
city: Rennes
country: France
facility: CHU de Rennes Pontchaillou
city: Rennes
country: France
facility: CHU de Rennes
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHRU Hôpitaux de tours
city: Versailles
country: France
facility: Hopital Privé de Versailles, Clinique des Franciscaines
Study officials:
References: