Small penis syndrome
Conditions
Interventions
Test group:Poly-L-lactic acid sodium hyaluronate gel Microspheres were injected
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
Male
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: The recruitment criteria including: (1)Adult males aged 20 to 65 years; (2)Men with small penis syndrome as clinically diagnosed by the investigator;Rather than those with ‘congenital small penis’; (3)Consent to stop sexual activity for 3 weeks after the trial procedure; (4)Able to understand and accept to comply with protocols during the entire course of the study, attend follow-up visits.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (1)Subjects with Congenital or acquired penile deformity, including Peyronie's disease and severe phimosis; (2)People who have acute or chronic skin diseases (infection or inflammation) at the injection site and surrounding skin (3)People who have erectile dysfunction diagnosed by the investigator; (4)People who had received any permanent penile implants; (5)Patients who had undergone penile surgery in the past , judged by the investigator to be not suitable for enrollment in this study; (6)Subjects with a history of severe multiple allergies or allergies leading to anaphylactic shock; (7)Subjects with hypertrophic scar or keloid at the injection site and its surrounding skin, or with a history of hypertrophic scar or keloid; (8)Contraindicated in patients with herpes; (9)People who are known to be allergic to the main ingredients of this product (L-polylactic acid, sodium hyaluronate, chitosan); (10)People who are known to be allergic to anesthetics such as lidocaine; (11)Patients who used anticoagulant or anti-platelet aggregation drugs (such as warfarin and aspirin) within 7 days before injection; Patients with hematopoietic dysfunction or coagulation dysfunction (Prothrombin time (PT) exceeded the upper limit of the normal range for more than 3 s); (12)Subjects with severe liver and kidney dysfunction (ALT, AST>2 ULN; Cr>1.5 times ULN),diagnosed by the investigator; (13)patients with severe diseases (e.g., severe chronic obstructive pulmonary disease, cardiogenic shock, malignant tumors, dementia, psychiatric disorders, autoimmune diseases, other than steroid 5a-reductase 2 deficiency, etc.) or physical conditions that would affect adherence to the protocol , judged by the investigator to be ineligible for participation in this study; (14)Patients received chemotherapy, immunosuppressant, immunomodulatory therapy (such as monoclonal antibodies,etc.), or systemic corticosteroids (except inhaled corticosteroids) within 3 months prior to enrollment; (15)Patients who are positive for antibodies to immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or treponema pallidum; (16)Participate in any other drug or device clinical trials (except registration studies) within 30 days prior to enrollment; (17)Other situations deemed unsuitable by the investigator for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in penile circumference of any penis (distal, terminal, or proximal) at 3 months after injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in penile circumference (distal, middle, and proximal) from baseline 1 month after injection (as measured by the investigator);Change in penile diameters (including distal, middle, and proximal diameters) from baseline 1 and 3 months after injection (subject measurement);Changes from baseline in the Chinese version of the Penis Size Cognition Questionnaire (CBAPS) at 3 months after injection;Change from baseline on the Simple International Index of Erectile Function Scale (IIEF-5) at 3 months after injection;Subject satisfaction evaluation;Vital signs: body temperature, heart rate, blood pressure, breathing;Laboratory tests: blood routine, urine routine, liver and kidney function, coagulation;Physical examination;Adverse event rate;Local reaction at injection site;Andrology examination; | — |
Countries
China
Contacts
Public ContactXin Wang
Beijing Hospital
Outcome results
None listed