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ClinicalTrials.gov ID

NCT05574244

Lead Sponsor

University Hospital, BordeauxOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

336Estimated

Last Update Posted

Apr 9, 2026Actual

Start Date

Sep 29, 2022Actual

Primary Completion Date

Mar 31, 2029Estimated

Completion Date

Mar 31, 2029Estimated

Official Title

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

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.

• Benign Prostatic Hyperplasia

• Partial surgery preserving the prostatic apex
• Conventional endoscopic prostatic surgery

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

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.

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University Hospital, BordeauxOTHER

nicolas.barry-delongchamps@aphp.fr

romain.mathieu@chu-rennes.fr