An observational study in Erectile Dysfunction, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Completed at 1 site in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Observational
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).
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:
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.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's enrollment of 2,800 is above the median of 130 across 125 observational studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 99 studies on the registry; 67 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with erectile dysfunction who visited the Urology Department of the Second Affiliated Hospital of Zhejiang University
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
medical history
Medical history refers to a comprehensive record of a patient's past and current health conditions, diseases, treatments, and related health events.
Time frame: at baseline
CDDU
Color Doppler Duplex Ultrasonography
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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: %
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: at baseline
Number of Erectile Events
This NPTR metric counts valid nocturnal erections, defined as having rigidity ≥60% lasting ≥10 minutes.
Time frame: at baseline
Mean Peak Rigidity
This NPTR indicator calculates the average percentage of maximum hardness achieved during all valid nocturnal erectile events.
Time frame: at baseline
Maximum Peak Rigidity
This NPTR parameter records the highest percentage of rigidity reached during any single nocturnal erectile event.
Time frame: at baseline
Mean Duration of Erection
This NPTR metric measures the average time, in minutes, that each valid nocturnal erection is sustained.
Time frame: at baseline
Total Erection Time
This NPTR indicator sums the total minutes of all valid nocturnal erections recorded throughout the entire testing period.
Time frame: at baseline
Axial Force or Circumference Change:
This NPTR parameter tracks physical changes in penile circumference (cm) or axial force (g) during nocturnal erections.
Time frame: at baseline
Plan to share: No — This is a retrospective observational study, no individual participant data sharing is planned
No publications or documents are linked to this record.
Ran from May 2021 to primary completion in Jul 2026, 62 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Second Affiliated Hospital, Zhejiang University, School of Medicine