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A prospective, single-arm, self-controlled clinical study of nocturnal penile erectile stiffness monitoring (NPTR) to assess the effect of bariatric surgery on erectile function in men with obesity and metabolic syndrome

A prospective, single-arm, self-controlled clinical study of nocturnal penile erection hardness monitoring to assess the effect of bariatric surgery on erectile function in men with obesity and metabolic syndrome

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050994
Enrollment
Unknown
Registered
2021-09-10
Start date
2021-09-08
Completion date
Unknown
Last updated
2022-05-16

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

Conditions

Obesity

Interventions

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who intend to undergo bariatric surgery and have no contraindications to surgery. 2. Body mass index (BMI) >=32.5kg/m^2 or 27.5= 11.1mmol/L; 2) Fasting blood glucose >= 7.0mmol/L; 3) Fasting blood glucose = 11.1mmol/L 2 hours after meals; 4) Glycated hemoglobin >= 6.5%; (3) Metabolic syndrome (IDF) includes: high triglyceride (fasting TG >= 1.7mmol/L), high density lipoprotein cholesterol (HDL-ch = 130mmHg or diastolic blood pressure >= 85mmHg); (4) Obesity-related comorbidities include abnormal glucose metabolism and insulin resistance, obstructive sleep apnea syndrome (OHSAS), nonalcoholic steatohepatitis, abnormal endocrine function, hyperuricemia, male sexual dysfunction, polycystic ovary syndrome, deformed arthritis, abnormal renal function, etc. 3. Male patients, aged 16-65 years. 4. Voluntarily sign the informed consent form and cooperate to complete the entire experiment.

Exclusion criteria

Exclusion criteria: 1. Secondary obesity caused by diseases that cause changes in growth hormone, adrenal cortex hormone, and thyroxine, such as acromegaly, Cushing's disease, hypothyroidism, etc. 2. Have a contagious skin or venereal disease, or have a rash or infected lesions in the area around the penis. 3. Those with intellectual disability or immaturity who cannot control their behaviors. 4. Severe coagulation disorder, or severe heart, brain, lung, liver, kidney and other diseases, uncontrolled hypertension (>= 150/100mmHg), symptomatic ischemic heart disease, cerebral infarction or obliterative arteriosclerosis, malignant tumor, poor general condition, difficult to tolerate general anesthesia and/or intolerable surgery. 5. Suffering from severe mental disorders (depression, schizophrenia, epilepsy) or long-term use of antipsychotic drugs. 6. There are congenital malformations and anatomical abnormalities of the genitals that obviously impair penile erection, or related diseases that cause organic erectile dysfunction, pelvic fractures, urethral rupture, after pelvic surgery (prostate, bladder, rectum), spinal trauma or surgery. 7. Have taken PDE5 inhibitor drugs for the first time within 1 week before screening, such as tadalafil, sildenafil, etc. 8. The investigator believes that there may be other circumstances that may increase the risk of subjects or interfere with the execution of clinical trials.

Design outcomes

Primary

MeasureTime frame
Hardness Vitality Units for Best Events;

Secondary

MeasureTime frame
IIEF-5;Erectile Rigidity;Erectile Duration;Tumescence Activity Units;

Countries

China

Contacts

Public ContactMao Shanhua

Huashan Hospital Affiliated to Fudan University

maoshanhua@163.com+86 13918635255

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026