Erectile DysfunctionNCT07913477
Retrospective Analysis of Erectile Dysfunction (ED) Patients Based on a Large-scale Clinical Database
An observational study of Erectile Dysfunction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this observational study is to analyze existing clinical data to characterize in male patients aged 18 and older diagnosed with Erectile Dysfunction (ED). The main questions it aims to answer are: What are the epidemiological features and comorbidity patterns (e.g., metabolic syndrome) in this patient… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- How many people
- 2,800 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Jul 2026
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with erectile dysfunction who visited the Urology Department of the Second Affiliated Hospital of Zhejiang University
Who may be able to join
- Patients clinically diagnosed with Erectile Dysfunction (ED);
- Age ≥ 18 years;
- Availability of International Index of Erectile Function-5 (IIEF-5) score records.
Who cannot join
- Missing key variables (e.g., International Index of Erectile Function-5 [IIEF-5] score, age, sex);
- Presence of severe psychiatric disorders or cognitive impairment precluding cooperation with scale assessments.
Trial locations and contacts
1 site in 1 country.
China1 site
The 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
The goal of this observational study is to analyze existing clinical data to characterize in male patients aged 18 and older diagnosed with Erectile Dysfunction (ED). The main questions it aims to answer are:
What are the epidemiological features and comorbidity patterns (e.g., metabolic syndrome) in this patient population?
Read more
How do sex hormone levels and penile hemodynamic parameters correlate with the severity of ED?
Is there consistency between objective NPTR monitoring parameters and subjective patient-reported scores (IIEF-5, EHS)?
This study does not have a comparison group or interventions. It is a retrospective analysis of existing data.
Participants will not be asked to do anything new. The research involves analyzing their de-identified data that was previously collected during routine clinical visits, which includes:
Demographic information, medical history, and lifestyle factors.
Results from laboratory tests (e.g., blood biochemistry, sex hormones).
Outcomes from diagnostic assessments (e.g., IIEF-5 questionnaires, CDDU, NPTR).
Read the detailed description
Erectile dysfunction (ED) is among the most prevalent sexual dysfunctions in men and is associated with substantial impairment of quality of life and psychological well-being. ED shares pathophysiological pathways with cardiovascular and metabolic disease: endothelial dysfunction, atherosclerosis, and hormonal dysregulation are recognized contributors to both conditions. The rising burden of metabolic syndrome (MetS) and its components-abdominal obesity, hyperglycemia, hypertriglyceridemia, and low high-density lipoprotein cholesterol (HDL-C)-together with population aging, has been accompanied by an increasing incidence of ED. Although the clinical assessment framework for ED is well established, integrating subjective instruments (the International Index of Erectile Function-5 [IIEF-5], the Erection Hardness Score [EHS]) with objective measures (nocturnal penile tumescence and rigidity [NPTR] monitoring, color Doppler duplex ultrasonography [CDDU] of the penis, penile elastometry), large-sample studies characterizing Chinese male ED patients remain scarce, and the interrelationships among metabolic factors, sex hormone profiles, penile hemodynamics, and ED severity have not been systematically examined at scale.
This is a single-center, retrospective, observational study based on secondary analysis of a previously curated clinical database of patients with ED. The database was derived from outpatient and inpatient records of the Department of Urology, The Second Affiliated Hospital, Zhejiang University School of Medicine, covering clinical data collected between May 2021 and August 2026, and comprises approximately 2,800 patients across 83 data fields. No new interventions, follow-up visits, or biological specimen collection will be performed; the study involves analysis of de-identified data obtained during routine clinical care.
The study comprises several complementary retrospective analyses:
- Epidemiological characterization of the ED population. Age distribution, comorbidity spectrum (hypertension, diabetes mellitus, hyperlipidemia, MetS), and lifestyle factors (smoking, alcohol consumption) will be described for the study population.
- ED severity and metabolic syndrome. The association between MetS and its individual components and ED severity, as graded by IIEF-5 score and EHS, will be evaluated using univariable and multivariable regression models with adjustment for potential confounders.
- Sex hormones and ED severity. Levels of total testosterone, free testosterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), prolactin, estradiol, and sex hormone-binding globulin will be compared across ED severity strata, and the predictive value of hormonal parameters for ED severity will be explored.
- Penile hemodynamic parameters across ED etiological subtypes. Cavernosal artery peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index(RI) will be compared among patients classified as arteriogenic, venogenic, or mixed-type ED.
- Concordance between objective monitoring and subjective scores. NPTR parameters (total erection duration, event duration, and penile rigidity and tumescence at the base and glans) will be correlated with IIEF-5 and EHS scores, and the diagnostic agreement between objective and subjective assessments will be quantified.
- Age-related differences. Clinical characteristics, comorbidity burden, ED severity, and laboratory indices will be compared across age strata.
- Exploratory analyses of other relationships supported by the available variables.
Variables to be abstracted include demographic and anthropometric data; medical history (hypertension, diabetes, hyperlipidemia, prior phosphodiesterase-5 inhibitor use, smoking and alcohol history, relevant trauma or surgery); MetS components; IIEF-5 and EHS scores; laboratory results (glycated hemoglobin,hepatic and renal function, lipid profile, and the sex hormone panel described above); CDDU parameters; elastometry values (Young's modulus at the bilateral glans and base); NPTR parameters; and self-reported sexual intercourse duration and frequency. Subsets of these variables will be selected for each sub-analysis according to its specific hypothesis.
Statistical analyses will be performed using SPSS or R. Continuous variables will be summarized as mean ± standard deviation or median (interquartile range), and categorical variables as frequencies (percentages). Between-group comparisons will use Student's t-test, Mann-Whitney U test, chi-square test, or Fisher's exact test; multi-group comparisons will use one-way ANOVA or the Kruskal-Wallis test. Correlations will be assessed with Pearson or Spearman coefficients, and multivariable logistic or linear regression will be used to adjust for confounding. Two-sided P values < 0.05 will be considered statistically significant. Because the analyses use an existing database, no prospective sample size calculation applies; the available sample is expected to support multivariable modeling, and the number of covariates in each model will be limited according to the effective sample size of the corresponding sub-analysis.
Data will be analyzed in de-identified form; direct identifiers will not be retained in analysis datasets, and access will be restricted to authorized study personnel. The study will be conducted in accordance with the Declaration of Helsinki and will commence only after approval by the institutional ethics committee. Given the retrospective use of existing clinical data with no additional patient contact, the study applies for a waiver of informed consent.
- Conditions
- Erectile Dysfunction
- Keywords
- erectile dysfunction, retrospective study, Metabolic Syndrome, Sex Hormones
- Medical subject headings
- Erectile Dysfunction, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ED Clinical Database | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
medical history
Medical history refers to a comprehensive record of a patient's past and current health conditions, diseases, treatments, and related health events.
Measured: at baseline
Secondary outcomes (44)
CDDU
Color Doppler Duplex Ultrasonography
Measured: at baseline
IIEF-5
The International Index of Erectile Function-5 (IIEF-5) is a validated 5-item self-administered questionnaire used to screen and assess the severity of erectile dysfunction over the preceding 6 months. Each item is scored on a 1-to-5 Likert scale, yielding a total score ranging from 5 (worst) to 25 (best). Severity is classified as follows: 22-25, no ED; 17-21, mild ED; 12-16, mild-to-moderate ED; 8-11, moderate ED; and 5-7, severe ED. Higher total scores indicate better erectile function, while lower scores reflect greater impairment. The IIEF-5 is widely used in both clinical practice and research as a simple, reliable tool for evaluating treatment outcomes.
Measured: at baseline and up to 6 months
EHS
The Erection Hardness Score (EHS) is a validated single-item, 4-point self-reported scale used to assess penile rigidity during sexual activity. The scoring criteria are as follows: 1 = the penis is larger but not hard; 2 = the penis is hard but not hard enough for penetration; 3 = the penis is hard enough for penetration but not completely hard; 4 = the penis is completely hard and fully rigid. The total score ranges from 1 (minimum) to 4 (maximum). Higher scores indicate better erection hardness and superior erectile function, while lower scores reflect greater impairment. Due to its simplicity and strong correlation with the IIEF, the EHS is widely used in both clinical practice and research as a quick, reliable tool for monitoring treatment response.
Measured: at baseline and at baseline and up to 6 months
ALT
Alanine Aminotransferase，a key enzyme mainly found in liver cells, serving as a sensitive biomarker for detecting liver damage.Unit of concentration:U/L
Measured: at baseline
AST
AST stands for Aspartate Aminotransferase, a liver enzyme released into the blood when liver or muscle cells are damaged.Unit of concentration:U/L
Measured: AT baseline
ALP
ALP stands for Alkaline Phosphatase, a group of enzymes mainly found in the liver, bile ducts, and bones, which is commonly measured in blood tests to help diagnose liver or bone disorders.Unit of concentration:U/L
Measured: at baseline
GGT
GGT stands for Gamma-Glutamyl Transferase, an enzyme primarily located in the liver, bile ducts, and kidneys, which is commonly measured in blood tests to help diagnose liver, biliary, or pancreatic disorders.
Unit of concentration: U/L
Measured: At baseline
TBIL
TBIL stands for Total Bilirubin, a metabolic product mainly formed from the breakdown of aging red blood cells, which is commonly measured in blood tests to help diagnose liver, biliary, or hemolytic disorders.
Unit of concentration: μmol/L
Measured: AT baseline
DBIL
DBIL stands for Direct Bilirubin (also known as Conjugated Bilirubin), a water-soluble pigment mainly formed in the liver through the metabolism of red blood cells, which is commonly measured in blood tests to help diagnose liver, biliary, or hemolytic disorders.Unit of concentration: μmol/L
Measured: at baseline
IBIL
IBIL stands for Indirect Bilirubin (also known as Unconjugated Bilirubin), a breakdown product of red blood cells that has not yet been processed by the liver, which is commonly measured in blood tests to help diagnose hemolytic disorders or liver dysfunction.
Unit of concentration: μmol/L
Measured: at baseline
TP
TP stands for Total Protein, a measurement of all proteins in the blood serum (primarily albumin and globulins), which is commonly measured in blood tests to help evaluate nutritional status, liver function, kidney function, or immune disorders.
Unit of concentration: g/L
Measured: at baseline
ALB
ALB stands for Albumin, a protein mainly synthesized by the liver and found in the blood plasma, which is commonly measured in blood tests to help assess liver function, nutritional status, and kidney disorders.
Unit of concentration: g/L
Measured: at baseline
GLB
GLB stands for Globulin, a mixture of proteins mainly produced by the immune system, which is commonly measured in blood tests to help diagnose liver diseases, chronic infections, autoimmune disorders, or certain blood cancers.
Unit of concentration: g/L
Measured: at baseline
A/G ratio
A/G ratio stands for Albumin/Globulin ratio, a value calculated by dividing the serum albumin level by the globulin level, which is commonly measured in blood tests to help assess liver function and nutritional or immune status.
Unit of concentration: dimensionless (ratio).
Measured: at baseline
Cr
Cr stands for Creatinine, a waste product generated by muscle metabolism, which is commonly measured in blood and urine tests to help evaluate kidney function and diagnose renal disorders.
Unit of concentration: μmol/L
Measured: at baseline
Bun
BUN stands for Blood Urea Nitrogen, a waste product formed when the liver breaks down protein, which is commonly measured in blood tests to help assess kidney function.
Unit of concentration: mmol/L
Measured: at baseline
UA
UA stands for Uric Acid, a waste product formed from the breakdown of purines in the body, which is commonly measured in blood tests to help diagnose gout, kidney disorders, or metabolic abnormalities.
Unit of concentration: μmol/L
Measured: at baseline
Cystatin C
Cystatin C , a low-molecular-weight protein produced at a constant rate by all nucleated cells in the body, which is commonly measured in blood tests to help evaluate kidney function, specifically the glomerular filtration rate (GFR), and to detect early kidney damage.
Unit of concentration: mg/L
Measured: at baseline
eGFR
eGFR stands for Estimated Glomerular Filtration Rate, a calculated metric that estimates the rate at which the kidneys filter waste from the blood, which is commonly measured in blood tests to help diagnose and stage chronic kidney disease.
Unit of concentration: mL/min
Measured: at baseline
FPG
FPG stands for Fasting Plasma Glucose, a core clinical metric measured in blood tests after an overnight fast (typically 8-12 hours without food), which is commonly used to evaluate basal insulin secretion, assess glucose metabolism, and diagnose diabetes or prediabetes.
Unit of concentration: mmol/L
Measured: at baseline
HbA1c
HbA1c stands for Hemoglobin A1c, a stable compound formed by the non-enzymatic binding of glucose to hemoglobin in red blood cells, which is commonly measured in blood tests to reflect average blood sugar levels over the past 2-3 months and to diagnose or monitor diabetes.
Unit of concentration: %
Measured: at baseline
TC
TC stands for Total Cholesterol, the sum of all cholesterol carried by lipoproteins in the blood, which is commonly measured in blood tests to help evaluate cardiovascular health and assess the risk of atherosclerosis and related heart diseases.
Unit of concentration: mmol/L
Measured: at baseline
TG
TG stands for Triglycerides, a type of fat (lipid) found in your blood that serves as the body's primary energy storage form, which is commonly measured in fasting blood tests to help assess cardiovascular risk and the potential for acute pancreatitis.
Unit of concentration: mmol/L
Measured: at baseline
HDL-C
HDL-C stands for High-Density Lipoprotein Cholesterol, a type of lipoprotein mainly synthesized in the liver, which is commonly measured in blood tests to help assess cardiovascular health and evaluate the risk of atherosclerosis and coronary heart disease.
Unit of concentration: mmol/L
Measured: at baseline
ApoA1
ApoA1 stands for Apolipoprotein A1, the major structural protein of high-density lipoprotein (HDL) mainly synthesized in the liver and small intestine, which is commonly measured in blood tests to help evaluate cardiovascular disease risk and assess cholesterol metabolism.
Unit of concentration: g/L
Measured: at baseline
ApoB
ApoB stands for Apolipoprotein B, a structural protein mainly found on the surface of atherogenic lipoproteins (such as LDL, VLDL, and IDL), which is commonly measured in blood tests to help assess the total number of atherogenic particles and evaluate cardiovascular disease risk.
Unit of concentration: g/L
Measured: at baseline
K⁺
K⁺ stands for Potassium, a vital electrolyte and major intracellular cation mainly found inside the body's cells, which is commonly measured in blood tests to help evaluate kidney function, fluid and electrolyte balance, and diagnose neuromuscular or cardiac disorders.
Unit of concentration: mmol/L
Measured: at baseline
Na⁺
Na⁺ stands for Sodium ion, the primary cation in extracellular fluid, which is routinely measured in blood tests to evaluate electrolyte balance and diagnose fluid or acid-base disorders.
Unit of concentration: mmol/L
Measured: at baseline
Cl-
Cl- stands for Chloride, the predominant anion found in the extracellular fluid, which is commonly measured in blood and urine tests to help evaluate electrolyte balance, hydration status, and acid-base disorders.
Unit of concentration: mmol/L
Measured: at baseline
Ca²⁺
Ca²⁺ stands for Ionized Calcium, a physiologically active form of calcium in the blood, which is commonly measured in blood tests to evaluate calcium metabolism, neuromuscular function, and diagnose conditions such as hypocalcemia or hypercalcemia.
Unit of concentration: mmol/L
Measured: at baseline
P
P stands for Phosphorus (Serum Phosphorus), an essential mineral and electrolyte primarily stored in bones and teeth, which is commonly measured in blood tests to help evaluate bone health, kidney function, and parathyroid gland disorders.
Unit of concentration: mmol/L
Measured: at baseline
Mg²⁺
Mg²⁺ stands for Magnesium ion, a vital mineral and electrolyte primarily stored in bones and intracellular fluids, which is commonly measured in blood tests to help diagnose and monitor neuromuscular disorders, cardiac arrhythmias, kidney dysfunction, and electrolyte imbalances.
Unit of concentration: mmol/L
Measured: at baseline
Total testosterone
Total testosterone stands for the total amount of the primary male sex hormone (androgen) in the blood, which is produced mainly in the testes in males and in smaller amounts by the ovaries and adrenal glands in females, and is commonly measured in blood tests to help evaluate reproductive health, sexual function, Unit of concentration: ng/dL
Measured: at baseline
free testosterone
Free testosterone stands for unbound testosterone, the biologically active fraction of circulating testosterone that is not bound to sex hormone-binding globulin (SHBG) or albumin, which is commonly measured in blood tests to help diagnose hypogonadism, polycystic ovary syndrome (PCOS), and other endocrine disorders.
Unit of concentration: pg/mL
Measured: at baseline
LH
LH stands for Luteinizing Hormone, a glycoprotein hormone produced by the anterior pituitary gland, which is commonly measured in blood tests to help evaluate reproductive system function, monitor ovulation, and diagnose conditions such as infertility, polycystic ovary syndrome (PCOS), or pituitary disorders.
Unit of concentration: IU/L
Measured: at baseline
FSH
FSH stands for Follicle-Stimulating Hormone, a glycoprotein hormone secreted by the anterior pituitary gland, which is commonly measured in blood tests to help evaluate reproductive function, diagnose infertility, and assess gonadal disorders.
Unit of concentration: U/L
Measured: at baseline
prolactin
Prolactin stands for Prolactin (also known as PRL), a protein hormone mainly produced by the anterior pituitary gland, which is commonly measured in blood tests to help diagnose pituitary tumors, hyperprolactinemia, or reproductive disorders.
Unit of concentration: μg/L
Measured: at baseline
estradiol
Estradiol stands for a naturally occurring steroid hormone and the most potent form of estrogen, which is primarily produced by the ovaries in females and in small amounts by the testes in males, and is commonly measured in blood tests to help evaluate reproductive function, monitor fertility treatments, and diagnose hormonal imbalances or menopausal status.
Unit of concentration: pmol/L (or pg/mL)
Measured: at baseline
Number of Erectile Events
This NPTR metric counts valid nocturnal erections, defined as having rigidity ≥60% lasting ≥10 minutes.
Measured: at baseline
Mean Peak Rigidity
This NPTR indicator calculates the average percentage of maximum hardness achieved during all valid nocturnal erectile events.
Measured: at baseline
Maximum Peak Rigidity
This NPTR parameter records the highest percentage of rigidity reached during any single nocturnal erectile event.
Measured: at baseline
Mean Duration of Erection
This NPTR metric measures the average time, in minutes, that each valid nocturnal erection is sustained.
Measured: at baseline
Total Erection Time
This NPTR indicator sums the total minutes of all valid nocturnal erections recorded throughout the entire testing period.
Measured: at baseline
Axial Force or Circumference Change:
This NPTR parameter tracks physical changes in penile circumference (cm) or axial force (g) during nocturnal erections.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 May 2021
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 2,800 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913477
- Sponsor's protocol ID
- 20260705
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a retrospective observational study, no individual participant data sharing is planned
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Erectile Dysfunction (ED) Patients Based on a Large-scale Clinical Database
- ClinicalTrials.gov ID
- NCT07913477
- Acronym / sponsor ID
- 20260705
- Conditions
- Erectile Dysfunction
- Keywords
- erectile dysfunction, retrospective study, Metabolic Syndrome, Sex Hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,800 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 3 Nov 2026 (actual)
- 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 goal of this observational study is to analyze existing clinical data to characterize in male patients aged 18 and older diagnosed with Erectile Dysfunction (ED). The main questions it aims to answer are:
What are the epidemiological features and comorbidity patterns (e.g., metabolic syndrome) in this patient population?
How do sex hormone levels and penile hemodynamic parameters correlate with the severity of ED?
Is there consistency between objective NPTR monitoring parameters and subjective patient-reported scores (IIEF-5, EHS)?
This study does not have a comparison group or interventions. It is a retrospective analysis of existing data.
Participants will not be asked to do anything new. The research involves analyzing their de-identified data that was previously collected during routine clinical visits, which includes:
Demographic information, medical history, and lifestyle factors.
Results from laboratory tests (e.g., blood biochemistry, sex hormones).
Outcomes from diagnostic assessments (e.g., IIEF-5 questionnaires, CDDU, NPTR).
Detailed description
Erectile dysfunction (ED) is among the most prevalent sexual dysfunctions in men and is associated with substantial impairment of quality of life and psychological well-being. ED shares pathophysiological pathways with cardiovascular and metabolic disease: endothelial dysfunction, atherosclerosis, and hormonal dysregulation are recognized contributors to both conditions. The rising burden of metabolic syndrome (MetS) and its components-abdominal obesity, hyperglycemia, hypertriglyceridemia, and low high-density lipoprotein cholesterol (HDL-C)-together with population aging, has been accompanied by an increasing incidence of ED. Although the clinical assessment framework for ED is well established, integrating subjective instruments (the International Index of Erectile Function-5 [IIEF-5], the Erection Hardness Score [EHS]) with objective measures (nocturnal penile tumescence and rigidity [NPTR] monitoring, color Doppler duplex ultrasonography [CDDU] of the penis, penile elastometry), large-sample studies characterizing Chinese male ED patients remain scarce, and the interrelationships among metabolic factors, sex hormone profiles, penile hemodynamics, and ED severity have not been systematically examined at scale.
This is a single-center, retrospective, observational study based on secondary analysis of a previously curated clinical database of patients with ED. The database was derived from outpatient and inpatient records of the Department of Urology, The Second Affiliated Hospital, Zhejiang University School of Medicine, covering clinical data collected between May 2021 and August 2026, and comprises approximately 2,800 patients across 83 data fields. No new interventions, follow-up visits, or biological specimen collection will be performed; the study involves analysis of de-identified data obtained during routine clinical care.
The study comprises several complementary retrospective analyses:
- Epidemiological characterization of the ED population. Age distribution, comorbidity spectrum (hypertension, diabetes mellitus, hyperlipidemia, MetS), and lifestyle factors (smoking, alcohol consumption) will be described for the study population.
- ED severity and metabolic syndrome. The association between MetS and its individual components and ED severity, as graded by IIEF-5 score and EHS, will be evaluated using univariable and multivariable regression models with adjustment for potential confounders.
- Sex hormones and ED severity. Levels of total testosterone, free testosterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), prolactin, estradiol, and sex hormone-binding globulin will be compared across ED severity strata, and the predictive value of hormonal parameters for ED severity will be explored.
- Penile hemodynamic parameters across ED etiological subtypes. Cavernosal artery peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index(RI) will be compared among patients classified as arteriogenic, venogenic, or mixed-type ED.
- Concordance between objective monitoring and subjective scores. NPTR parameters (total erection duration, event duration, and penile rigidity and tumescence at the base and glans) will be correlated with IIEF-5 and EHS scores, and the diagnostic agreement between objective and subjective assessments will be quantified.
- Age-related differences. Clinical characteristics, comorbidity burden, ED severity, and laboratory indices will be compared across age strata.
- Exploratory analyses of other relationships supported by the available variables.
Variables to be abstracted include demographic and anthropometric data; medical history (hypertension, diabetes, hyperlipidemia, prior phosphodiesterase-5 inhibitor use, smoking and alcohol history, relevant trauma or surgery); MetS components; IIEF-5 and EHS scores; laboratory results (glycated hemoglobin,hepatic and renal function, lipid profile, and the sex hormone panel described above); CDDU parameters; elastometry values (Young's modulus at the bilateral glans and base); NPTR parameters; and self-reported sexual intercourse duration and frequency. Subsets of these variables will be selected for each sub-analysis according to its specific hypothesis.
Statistical analyses will be performed using SPSS or R. Continuous variables will be summarized as mean ± standard deviation or median (interquartile range), and categorical variables as frequencies (percentages). Between-group comparisons will use Student's t-test, Mann-Whitney U test, chi-square test, or Fisher's exact test; multi-group comparisons will use one-way ANOVA or the Kruskal-Wallis test. Correlations will be assessed with Pearson or Spearman coefficients, and multivariable logistic or linear regression will be used to adjust for confounding. Two-sided P values < 0.05 will be considered statistically significant. Because the analyses use an existing database, no prospective sample size calculation applies; the available sample is expected to support multivariable modeling, and the number of covariates in each model will be limited according to the effective sample size of the corresponding sub-analysis.
Data will be analyzed in de-identified form; direct identifiers will not be retained in analysis datasets, and access will be restricted to authorized study personnel. The study will be conducted in accordance with the Declaration of Helsinki and will commence only after approval by the institutional ethics committee. Given the retrospective use of existing clinical data with no additional patient contact, the study applies for a waiver of informed consent.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ED Clinical Database | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with erectile dysfunction who visited the Urology Department of the Second Affiliated Hospital of Zhejiang University
Key inclusion criteria (3 listed)
- Patients clinically diagnosed with Erectile Dysfunction (ED);
- Age ≥ 18 years;
- Availability of International Index of Erectile Function-5 (IIEF-5) score records.
Key exclusion criteria (2 listed)
- Missing key variables (e.g., International Index of Erectile Function-5 [IIEF-5] score, age, sex);
- Presence of severe psychiatric disorders or cognitive impairment precluding cooperation with scale assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
medical history
Time frame: at baseline
Medical history refers to a comprehensive record of a patient's past and current health conditions, diseases, treatments, and related health events.
44 secondary outcomes
CDDU
Time frame: at baseline
IIEF-5
Time frame: at baseline and up to 6 months
EHS
Time frame: at baseline and at baseline and up to 6 months
ALT
Time frame: at baseline
AST
Time frame: AT baseline
ALP
Time frame: at baseline
GGT
Time frame: At baseline
TBIL
Time frame: AT baseline
DBIL
Time frame: at baseline
IBIL
Time frame: at baseline
TP
Time frame: at baseline
ALB
Time frame: at baseline
GLB
Time frame: at baseline
A/G ratio
Time frame: at baseline
Cr
Time frame: at baseline
Bun
Time frame: at baseline
UA
Time frame: at baseline
Cystatin C
Time frame: at baseline
eGFR
Time frame: at baseline
FPG
Time frame: at baseline
HbA1c
Time frame: at baseline
TC
Time frame: at baseline
TG
Time frame: at baseline
HDL-C
Time frame: at baseline
ApoA1
Time frame: at baseline
ApoB
Time frame: at baseline
K⁺
Time frame: at baseline
Na⁺
Time frame: at baseline
Cl-
Time frame: at baseline
Ca²⁺
Time frame: at baseline
P
Time frame: at baseline
Mg²⁺
Time frame: at baseline
Total testosterone
Time frame: at baseline
free testosterone
Time frame: at baseline
LH
Time frame: at baseline
FSH
Time frame: at baseline
prolactin
Time frame: at baseline
estradiol
Time frame: at baseline
Number of Erectile Events
Time frame: at baseline
Mean Peak Rigidity
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. This is a retrospective observational study, no individual participant data sharing is planned
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Erectile Dysfunction, Electric Stimulation
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 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: finished, as of the sponsor's last update on 3 Nov 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medical history (time frame: at baseline). 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 3 Nov 2026.