Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05574244

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
336 (estimated)
Sponsor
University Hospital, Bordeaux · Academic / Other
Sex
Male
Age
40 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPartial surgery preserving the prostatic apexPartial Endoscopic resection of prostate to conserve apex
PROCEDUREConventional endoscopic prostatic surgeryEndoscopic resection of prostate.

Timeline

Start date
2022-09-29
Primary completion
2029-03-31
Completion
2029-03-31
First posted
2022-10-10
Last updated
2026-04-09

Locations

17 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05574244. Inclusion in this directory is not an endorsement.