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临床试验/NCT02573805
NCT02573805Unknown不适用

the Evaluation of Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Previous Rigiscan parameters analyzed by Rigiscan plus software

研究概览

简要总结

The purpose of this study is to evaluate the diagnostic value of Rigiscan (nocturnal penile tumescence and rigidity, NPTR ) test in erectile dysfunction of Chinese males.

详细描述

The Rigiscan test is used to evaluate the NPTR parameters. The "normal" NPTR parameter is provided by the Rigiscan manufacturer based on a clinical study on 500 American males. Original studies of NPTR parameters on Chinese males are warranted. On the other hand, during the past decades, several new NPTR parameters have been developed, like tip TAU (tip tumescence activity units), tip RAU (tip rigidity activity units), base TAU (base tumescence activity units), base RAU (base rigidity activity units), but their diagnostic values have been less evaluated. Basd on the these background, we determined to observe the clinical manifestation of these new parameters and to establish the "normal criteria" of NPTR parameters in Chinese males. This could be clinically beneficial in the differential diagnosis of organic and psychological erectile dysfunction.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • patients in a stable and heterosexual partnership with a fixed sexual partner for more than 6 months;
  • age≥20 year;
  • complete the validated International Index of Erectile Function (IIEF-5) questionnaire.

排除标准

  • advanced age (≥65);
  • pelvic trauma
  • thyroid diseases
  • metabolic diseases
  • hypogonadism and other hormonal disorders
  • sleep disorders
  • penile deformities
  • taking drugs that may interfere with erectile function.

结局指标

主要结局

Previous Rigiscan parameters analyzed by Rigiscan plus software

时间窗: within 2 days after the Rigiscan test

number of erectile events (per night), Duration of tip erections≥60% (min),duration of base erections ≥ 60% (min)

次要结局

  • newly developed Rigiscan parameters analyzed by Rigiscan plus software(within 2 days after the Rigiscan test)

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leilei Zhu

doctor leilei zhu

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (1)

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