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
- Benign Prostatic Hyperplasia
- Interventions
- Procedure: Conventional endoscopic prostatic surgeryProcedure: Partial surgery preserving the prostatic apex
- Registration Number
- NCT05574244
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 336
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional endoscopic prostatic surgery Conventional endoscopic prostatic surgery Endoscopic resection of prostate. Partial surgery preserving the prostatic apex Partial surgery preserving the prostatic apex 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).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Evaluation of ejaculation and global sexual life 1 month, 3 months, 6 months,12 months, and 36 months after surgery 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
Evaluation of complication rates 1 month, 3 months, 6 months,12 months, and 36 months after surgery Re-intervention rate
Evaluation of lower urinary tract symptoms 1 month, 3 months, 6 months,12 months, and 36 months after surgery Qmax (non-inferiority test) not performed at 1 month
Trial Locations
- Locations (15)
CH Pays d'Aix
🇫🇷Aix-en-Provence, France
CHU Angers
🇫🇷Angers, France
Hôpital Claude Huriez
🇫🇷Lille, France
Hôpital Tenon
🇫🇷Paris, France
CHU Mondor
🇫🇷Créteil, France
Polyclinique Saint George
🇫🇷Nice, France
Centre Hospitalier Universitaire de Bordeaux
🇫🇷Bordeaux, France
CHU de Limoges
🇫🇷Limoges, France
Hôpital cochin
🇫🇷Paris, France
Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon Sud
🇫🇷Pierre-Bénite, France
Hôpital Privé des Côtes D'Armor
🇫🇷Plérin, France
Clinique Pasteur
🇫🇷Toulouse, France
CHRU Hôpitaux de tours
🇫🇷Tours, France
Hôpital Prive Francheville
🇫🇷Périgueux, France
Hopital Privé de Versailles, Clinique des Franciscaines
🇫🇷Versailles, France