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Clinical trial of acellular allogeneic dermal soft tissue repair material for the treatment of premature ejaculation

Clinical trial of acellular allogeneic dermal soft tissue repair material for the treatment of premature ejaculation

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095236
Enrollment
Unknown
Registered
2025-01-03
Start date
2020-09-21
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Premature ejaculation

Interventions

Experimental group:The experimental group consisted of circumcision combined with allografted dermis stripping.
Control group:With circumcision as the control group, it is equivalent to a sham operation.

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Patients with long prepuce and primary premature ejaculation; 2.20-40 years old, male; 3.Heterosexual, with stable partners for more than half a year and regular sexual life, sexual life frequency>=1 times/week; 4.International Erectile Function Score (IIEF-5>=21); 5.Poor effect of oral drug therapy (PEDT score >8), and the drug has been stopped for more than two weeks; 6.Strong willingness to operate; 7.Can accept postoperative penis thickening and lengthening; 8.Agree to sign informed consent forms and be able to follow medical advice and regular follow-up visits.

Exclusion criteria

Exclusion criteria: 1.· Does not meet the inclusion criteria; 2.Urinary system infection; 3.penile flexion deformity; 4.Patients with penile sclerosis and scrotal diseases; 5.Testosterone level less than 2.3ng/ml; 6.Abnormal blood pressure (systolic pressure above 140mmHg, diastolic pressure above 90mmHg); 7.Fasting blood glucose index is greater than 8mmol/L; 8.Patients with a history of serious diseases of the immune system that cannot be controlled and cannot meet surgical standards; 9.History of mental illness; 10.Patients with severe anxiety and depression (PHQ-9 score greater than 14, GAD-7 score greater than 13).

Design outcomes

Secondary

MeasureTime frame
Penis measurement (circumference, length);Premature Ejaculation;sexual function;Penile thickening subject selection and satisfaction;Erectile Function;Depression;Clinical efficacy;

Primary

MeasureTime frame
The treatment was effective 6 months after operation;

Countries

China

Contacts

Public ContactYiming yuan

Peking University First Hospital

yuan.ym@126.com+86 139 1050 8732

Outcome results

None listed

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