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临床试验/NCT03547596
NCT03547596Unknown不适用

Impact of Treatment of Obstructive Sleep Apnea Syndrome by Continuous Positive Airway Pressure Equipment at Night on the Lower Urinary Tract Symptoms and the Erectile Dysfunction

CHU de Reims1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年4月29日最近更新:
适应症

试验速览

阶段
不适用
发起方
CHU de Reims
入组人数
300
试验地点
1
主要终点
erectile dysfunction

研究概览

简要总结

To treat lower urinary tract symptoms (LUTS) and erectile dysfunction (ED), we mainly have symptomatic drug treatments. Some patients are resistant to the treatments that we have or are forced to stop treatments because of side effects.

It would be interesting to focus on comorbidities and to evaluate whether it is possible to improve the urological symptoms by taking care the comorbidities, which would consist in an etiological treatment of the urological symptoms.

The aim of the study is to evaluate the evolution of low urinary tract disorders (LUTS) and erectile dysfunction (ED) in patients with obstructive sleep apnea syndrome (OSAS) following by continuous positive airway pressure equipment (CPAP) at night.

Participation in the study will be offered to all patients, men and women, consulting or hospitalized in the sleep unit of the department of pneumology CHU of Reims for a nocturnal ventilatory polygraphy or a polysomnography diagnostic of OSAS.

Men will complete three questionnaires about LUTS and DE, women one questionnaire about LUTS. The questionnaires will be completed twice, the first time when consulting at the sleep unit for nocturnal ventilatory polygraphy or a polysomnography diagnostic of OSAS ; the second time during the pneumology consultation three months later. We will compare the results between the questionnaires to assess whether OSAS equipment with CPAP has improved urologic symptoms.

If the management of OSAS allows an improvement of lower urinary tract disorders and / or an improvement of erectile dysfunction, these results would be interesting for the management of patients resistant to symptomatic drug treatments or to stop them because of iatrogenic side effects.

Etiological rather than symptomatic management would also have long-term benefits, both in improving the overall quality of life of the patient and in the medical and economic field.

It might be interesting to identify in urology consultation among patients consulting for LUTS or ED, patients at risk of presenting OSAS and referring them to a pulmonologist to manage OSAS if it exists, from the beginning of the urological care.

详细描述

Obstructive sleep apnea syndrome (OSAS) is the most common nocturnal breathing disorder. It is characterized by the occurrence, during sleep, of repeated episodes of complete collapse (apnea) or incomplete (hypopneas) of the upper airways. OSAS is a pathology that, through its cardiovascular and metabolic complications, its impact on daytime vigilance, represents a real public health problem. The prevalence of OSA is estimated at 2% in women and 4% in men aged 30 to 60 years. Recent studies estimate that nearly 2 million French people will be affected by this pathology.

The lower urinary tract symptoms (LUTS) include: disorders of the filling phase (urinary incontinence, diurnal and nocturnal pollakiuria, nocturia, urgency), disorders of the urinary phase, dysuria (weakness of the jet, urination by pushing, urinary burns), symptoms of the post-mictionnal phase (incomplete bladder emptying sensation).

LUTS have several etiologies. Dysuria is cause by obstacle under vesical (benign prostatic hyperplasia, urethral stenosis, bladder neck disease), neurological bladder, genital prolapse, drug etiology (parasympatholytic). Concerning pollakiuria and urgency there are bladder etiologies (cystitis, foreign body, tumor, neurological bladder), sub-bladder obstruction, extra-vesical etiologies (infectious pathology of contact, pregnancy, extrinsic tumor compression).

LUTS are responsible for an alteration of the quality of life. In men, LUTS are often caused by benign prostatic hypertrophy (BPH), which is one of the most common conditions in men over 40 years of age. The prevalence of BPH is variable in the literature: in men over 50 years of age with moderate symptomatology, the prevalence is of the order of 25%, it is estimated at 50 to 75% for men 65 years and over.

The prevalence of overactive bladder is estimated at 14.4% in France, it increases with age and among women.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

erectile dysfunction

时间窗: Day 0

Evaluation of the lower urinary tract symptoms using "International Index of Erectile Function"

lower urinary tract symptoms

时间窗: Day 0

Evaluation of the lower urinary tract symptoms using "UrinarySymptom Profil"

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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