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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-29

Study Completion Date

2029-03-31

Brief Summary

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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.

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Detailed Description

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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

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non inferiority Comparative single-blinded (patient) multicentre randomised clinical trial in two parallel groups:

* Group 1: Conventional endoscopic prostatic surgery
* Group 2: Partial surgery preserving the prostatic apex

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

* The clinical research assistant will fill-out the electronic case report form (eCRF) "randomisation" page and perform the randomisation. The site will immediately provide the study identification number for the patient and the allocation group.
* The clinical research assistant will print the result of the randomisation. The printed document will be placed in a sealed envelope that will be stored in the patient's file.
* The surgeon will open the envelope in the operating theatre once the patient has been placed under general anaesthesia.

To prevent breaking the blinding post-operatively, the complete or partial aspect of endoscopic resection will not be mentioned in the surgical report (the patient will be specifically informed of that particular point before signing the informed consent). The complete or partial aspect of surgery will be revealed to patients at the end of follow-up, and in case of any surgical problem (e.g. need for re-intervention) or consent withdrawal.

Study Groups

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Conventional endoscopic prostatic surgery

Endoscopic resection of prostate.

Group Type EXPERIMENTAL

Conventional endoscopic prostatic surgery

Intervention Type PROCEDURE

Endoscopic resection of prostate.

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).

Group Type EXPERIMENTAL

Partial surgery preserving the prostatic apex

* 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.

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No