NCT05574244 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
| NCT ID | NCT05574244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 336 participants |
| Start Date | 2022-09-29 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 336 participants in total. It began in 2022-09-29 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05574244 clinical trial?
This trial is open to male participants only, aged 40 Years or older, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05574244 currently recruiting?
Yes, NCT05574244 is actively recruiting participants. Contact the research team at gregoire.robert@chu-bordeaux.fr for enrollment information.
Where is the NCT05574244 trial being conducted?
This trial is being conducted at Aix-en-Provence, France, Angers, France, Bordeaux, France, Créteil, France and 11 additional locations.
Who is sponsoring the NCT05574244 clinical trial?
NCT05574244 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 336 participants.