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

Not Applicable

Recruiting

• Conditions: Benign Prostatic Hyperplasia

• 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.

Study Timeline

• Study First Submitted: 2022-09-13
• Study Start: 2022-09-29
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-10
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-06
• Primary Completion: 2029-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 336

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 (18)

Hôpital Nord Marseille; 🇫🇷 Marseille, France

CHU de Reims- Hôpital Robert Debré; 🇫🇷 Rennes, France

CHU de Rennes Pontchaillou; 🇫🇷 Rennes, France

CHU de Rennes; 🇫🇷 Rennes, France

CH Pays d'Aix; 🇫🇷 Aix-en-Provence, France

CHU Angers; 🇫🇷 Angers, France

Centre Hospitalier Universitaire de Bordeaux; 🇫🇷 Bordeaux, France

CHU Mondor; 🇫🇷 Créteil, France

Hôpital Claude Huriez; 🇫🇷 Lille, France

CHU de Limoges; 🇫🇷 Limoges, France

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