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Prostatic Hyperplasia, Benign clinical trials

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NCT ID: NCT05157724 Withdrawn - Clinical trials for Prostatic Hyperplasia, Benign

Observational Study to Compare Two Prostate Laser Enucleation Techniques in Terms of Urinary Incontinence

ENUPLASMHO
Start date: November 2021
Phase:
Study type: Observational

Benign prostatic hypertrophy or prostatic adenoma is a benign tumour that develops in the central part of the prostate. Prostatic adenoma can result in the progressive appearance of a difficulty in evacuating the bladder or frequent urges to urinate and other complications (lithiasis, haematuria, urinary retention, etc.). Surgery is indicated when medical treatment is no longer effective and in the case of complications. The endoscopic techniques for treating prostate adenoma, PLASMA and HOLEP, are recognised and recommended by the French Association of Urology and the European Association of Urology (EAU) as Gold Standard techniques in view of the good results reported in the literature, the low rate of complications compared to the other techniques, and the reduced hospitalisation rate. For prostate volumes less than 80cc, there is no difference between HOLEP and Bipolar Plasma Enucleation of the Prostate (BTUEP) in terms of International Prostate Symptom Score (IPSS), Qmax, and reoperation rate at 12 months. The surgeon's experience is the most important factor influencing the risk of complications for HOLEP. Urinary incontinence after HOLEP according to Houssin et al. is 14.5% at 3 months and 4.2% at 6 months, the risk factors identified were surgeon experience and the existence of diabetes. Comparative evaluation of the two techniques is less frequent, hence the interest of our prospective and multicentre study. In this study, the investigators hope to demonstrate a better outcome of the PLASMA technique in terms of post-operative residual urinary incontinence.

NCT ID: NCT03669692 Withdrawn - Metabolic Syndrome Clinical Trials

Open Randomized Clinical Trial to Evaluate the Effects of Intermittent Caloric Restriction in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

Start date: July 10, 2018
Phase: N/A
Study type: Interventional

Lower urinary tract symptoms (LUTS) include filling, emptying or post-voiding state alterations; producing symptomatology depending of the underline mechanism. Benign prostatic hyperplasia (BPH) is the most common underlying disease, which increases with age and significantly affects men over 50 years. There are currently no prevention or curative treatment guidelines, as their pathophysiological mechanism is not exactly known. Several factors have been implicated, such as hormones, aging, lifestyle or diet. BPH is associated with metabolic disorders, the basis of which is insulin resistance and its associated pathologies: diabetes, hypertension, obesity, dyslipidemia and metabolic syndrome. Patients without these metabolic signs have a lower incidence of BPH and / or LUTS. Insulin resistance (IR) is associated with greater proliferation and a reduction of cellular apoptosis at the prostate level; leading to an increase in prostate volume or symptoms. Likewise, the autonomic nervous system (ANS) imbalance, both in favor of sympathetic (emptying symptoms) or parasympathetic (filling symptoms), influences LUTS. SNA activity can be measured non-invasively, repetitively and effectively by measuring the heart rate variability (HRV). Caloric restriction with optimal nutrition (CRON, hereinafter only CR) is the most physiologically adapted nutritional alternative to our ancestral needs and has been shown in humans to reduce insulin resistance and associated pathologies. It has also been observed that CR improves the balance of the SNA and allows to improve LUTS. Proliferation inhibition and prostatic apoptosis induction, mediated through CR, by insulin-IGF-1 axis reduction and mTOR metabolic pathways inhibition, are the central axis of this project. CR will be used to reduce insulin resistance, IGF expression and inhibition of the PI3K / AKT / mTOR pathway, to reduce prostate cell proliferation and promote prostatic tissue apoptosis; in this way it will be possible to reduce its volume and improve the symptomatology. Additionally, CR will allow us to evaluate the potential benefits it has on certain metabolic diseases (diabetes, dyslipidemia, obesity, hypertension, etc.), anthropometric values (BMI, abdominal perimeter and skin folds) and autonomic nervous system functionality (HRV) .