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Clinical Trials in France / NCT05574244
Recruiting Not applicable

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

NCT05574244 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-09-29
Last updated
2026-04-09

Condition(s) studied

Benign Prostatic Hyperplasia

Investigational drug(s) / intervention(s)

Partial surgery preserving the prostatic apexConventional endoscopic prostatic surgery

Partial surgery preserving the prostatic apex: Partial Endoscopic resection of prostate to conserve apex

Conventional endoscopic prostatic surgery: Endoscopic resection of prostate.

Study 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.

Eligibility

Sex
MALE
Min age
40 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
CH Pays d'Aix Aix-en-Provence France Recruiting
CHU Angers Angers France Recruiting
Centre Hospitalier Universitaire de Bordeaux Bordeaux France Recruiting
CHU Mondor Créteil France Withdrawn
Hôpital Claude Huriez Lille France Withdrawn
CHU de Limoges Limoges France Recruiting
Hôpital Nord Marseille Marseille France Recruiting
Polyclinique Saint George Nice France Recruiting
Hôpital cochin Paris France Recruiting
Hôpital Prive Francheville Périgueux France Recruiting
Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon Sud Pierre-Bénite France Recruiting
Hôpital Privé des Côtes D'Armor Plérin France Recruiting
CHU de Reims- Hôpital Robert Debré Rennes France Recruiting
CHU de Rennes Rennes France Recruiting
Clinique Pasteur Toulouse France Withdrawn
CHRU Hôpitaux de tours Tours France Withdrawn
Hopital Privé de Versailles, Clinique des Franciscaines Versailles France Recruiting

More University Hospital, Bordeaux trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05574244 on ClinicalTrials.gov ↗ ← All trials in France