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

October 10, 2015 updated by: Leilei Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Yutian Dai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Chinese males ≥20 years

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
erectile dysfunction group
International Index of Erectile Function (IIEF-5) questionnaire≥22 Rigiscan test are performed for two nights
Device: Rigiscan test
Rigiscan tests are performed in enrolled subjects for consecutive two nights.
control group
International Index of Erectile Function (IIEF-5) questionnaire<22 Rigiscan test are performed for two nights
Device: Rigiscan test
Rigiscan tests are performed in enrolled subjects for consecutive two nights.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Previous Rigiscan parameters analyzed by Rigiscan plus software
Time Frame: 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)
within 2 days after the Rigiscan test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
newly developed Rigiscan parameters analyzed by Rigiscan plus software
Time Frame: within 2 days after the Rigiscan test
RAU 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 (%)
within 2 days after the Rigiscan test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Principal Investigator: l zhu, doctor, Drum tower Hospital, school of Medicine, Nanjing University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

October 9, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 10, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPTR in 2015-09-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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