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
Location: See all (18) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CH Pays d'Aix
RECRUITING
Aix-en-provence
CHU Angers
RECRUITING
Angers
Centre Hospitalier Universitaire de Bordeaux
RECRUITING
Bordeaux
CHU Mondor
WITHDRAWN
Créteil
Hôpital Claude Huriez
WITHDRAWN
Lille
CHU de Limoges
RECRUITING
Limoges
Hôpital Nord Marseille
RECRUITING
Marseille
Polyclinique Saint George
RECRUITING
Nice
Hôpital cochin
RECRUITING
Paris
Hôpital Prive Francheville
RECRUITING
Périgueux
Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
Hôpital Privé des Côtes D'Armor
RECRUITING
Plérin
CHU de Reims- Hôpital Robert Debré
RECRUITING
Rennes
CHU de Rennes
RECRUITING
Rennes
CHU de Rennes Pontchaillou
RECRUITING
Rennes
Clinique Pasteur
WITHDRAWN
Toulouse
CHRU Hôpitaux de tours
WITHDRAWN
Tours
Hopital Privé de Versailles, Clinique des Franciscaines
RECRUITING
Versailles
Contact Information
Primary
Grégoire ROBERT
gregoire.robert@chu-bordeaux.fr
05.57.82.06.87
Backup
Méric BEN BOUJEMA
meric.ben-boujema@chu-bordeaux.fr
05.57.82.06.87
Time Frame
Start Date: 2022-09-29
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 336
Treatments
Experimental: Conventional endoscopic prostatic surgery
Endoscopic resection of prostate.
Experimental: 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).
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov