the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
NPTR
the Evaluation of Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
1 other identifier
observational
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 9, 2015
CompletedFirst Posted
Study publicly available on registry
October 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 14, 2015
October 1, 2015
11 months
October 9, 2015
October 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Previous Rigiscan parameters analyzed by Rigiscan plus software
number of erectile events (per night), Duration of tip erections≥60% (min),duration of base erections ≥ 60% (min)
within 2 days after the Rigiscan test
Secondary Outcomes (1)
newly developed Rigiscan parameters analyzed by Rigiscan plus software
within 2 days after the Rigiscan test
Study Arms (2)
erectile dysfunction group
International Index of Erectile Function (IIEF-5) questionnaire≥22 Rigiscan test are performed for two nights
control group
International Index of Erectile Function (IIEF-5) questionnaire\<22 Rigiscan test are performed for two nights
Interventions
Rigiscan tests are performed in enrolled subjects for consecutive two nights.
Eligibility Criteria
Chinese males ≥20 years
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yutian Dai
Nanjing, Jiangsu, 210008, China
Biospecimen
Rigiscan parameters analyzed by Rigiscan plus software
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
l zhu, doctor
Drum tower Hospital, school of Medicine, Nanjing University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor leilei zhu
Study Record Dates
First Submitted
October 9, 2015
First Posted
October 12, 2015
Study Start
September 1, 2015
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
October 14, 2015
Record last verified: 2015-10