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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02573805
Acronym
NPTR
Enrollment
1000
Registered
2015-10-12
Start date
2015-09-30
Completion date
2016-10-31
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

nocturnal penile tumescence and rigidity, erectile dysfunction, Chinese males

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.

Detailed description

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.

Interventions

DEVICERigiscan test

Rigiscan tests are performed in enrolled subjects for consecutive two nights.

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

1. patients in a stable and heterosexual partnership with a fixed sexual partner for more than 6 months; 2. age≥20 year; 3. complete the validated International Index of Erectile Function (IIEF-5) questionnaire.

Exclusion criteria

1. advanced age (≥65); 2. pelvic trauma 3. thyroid diseases 4. metabolic diseases 5. hypogonadism and other hormonal disorders 6. sleep disorders 7. penile deformities 8. taking drugs that may interfere with erectile function.

Design outcomes

Primary

MeasureTime frameDescription
Previous Rigiscan parameters analyzed by Rigiscan plus softwarewithin 2 days after the Rigiscan testnumber of erectile events (per night), Duration of tip erections≥60% (min),duration of base erections ≥ 60% (min)

Secondary

MeasureTime frameDescription
newly developed Rigiscan parameters analyzed by Rigiscan plus softwarewithin 2 days after the Rigiscan testRAU tip, TAU tip, RAU base, TAU base, average tip tumescence (cm), average base tumescence(cm), average event rigidity of tip (%),aveage event rigidity of base (%)

Countries

China

Contacts

Primary Contactl zhu, doctor
13770864680@163.com+8602568182222
Backup Contactyutian dai, doctor
13913957628@163.com+8602568182222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026