Erectile DysfunctionNPTRNCT02573805
the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
An observational study of Erectile Dysfunction, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Rigiscan test
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Oct 2016
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese males ≥20 years
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Rigiscan test
- Keywords
- nocturnal penile tumescence and rigidity, erectile dysfunction, Chinese males
- Medical subject headings
- Erectile Dysfunction, Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigiscan testDevice
Rigiscan tests are performed in enrolled subjects for consecutive two nights.
| Study group | Role | What they receive |
|---|---|---|
| erectile dysfunction group | International Index of Erectile Function (IIEF-5) questionnaire≥22 Rigiscan test are performed for two nights Receives: Device: Rigiscan test | |
| control group | International Index of Erectile Function (IIEF-5) questionnaire<22 Rigiscan test are performed for two nights Receives: Device: Rigiscan test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: within 2 days after the Rigiscan test
Secondary outcomes (1)
newly developed Rigiscan parameters analyzed by Rigiscan plus software
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 (%)
Measured: within 2 days after the Rigiscan test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leilei Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- l zhu, doctor, Principal investigator, Drum tower Hospital, school of Medicine, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573805
- Sponsor's protocol ID
- NPTR in 2015-09-24
- Acronym
- NPTR
- Status last verified
- Oct 2015
- First submitted
- 9 Oct 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Evaluation of Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
- ClinicalTrials.gov ID
- NCT02573805
- Acronym / sponsor ID
- NPTR / NPTR in 2015-09-24
- Conditions
- Erectile Dysfunction
- Keywords
- nocturnal penile tumescence and rigidity, erectile dysfunction, Chinese males
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erectile dysfunction group | – | Device: Rigiscan testInternational Index of Erectile Function (IIEF-5) questionnaire≥22 Rigiscan test are performed for two nights |
| control group | – | Device: Rigiscan testInternational Index of Erectile Function (IIEF-5) questionnaire<22 Rigiscan test are performed for two nights |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese males ≥20 years
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- advanced age (≥65);
- pelvic trauma
- thyroid diseases
- metabolic diseases
- hypogonadism and other hormonal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rigiscan testRigiscan tests are performed in enrolled subjects for consecutive two nights. | Device | control group, erectile dysfunction group |
Primary outcome
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)
1 secondary outcome
newly developed Rigiscan parameters analyzed by Rigiscan plus software
Time frame: within 2 days after the Rigiscan test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
l zhu, doctor principal investigator
Drum tower Hospital, school of Medicine, Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact l zhu, doctor (+8602568182222, 13770864680@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Previous Rigiscan parameters analyzed by Rigiscan plus software (time frame: within 2 days after the Rigiscan test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.