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A multicenter, randomized controlled clinical study comparing the efficacy of LIPUS versus PDE5 inhibitor in ED treatment

A multicenter, randomized controlled clinical study comparing the efficacy of LIPUS versus PDE5 inhibitor in ED treatment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036674
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-11-02
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

Erectile dysfunction

Interventions

control group:Oral PDE5 inhibitor
experimental group:LIPUS

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Aged 20-60 years, male; 2) General health, stable heterosexual partner for more than 3 months; 3) Mild to moderate ED (IIEF-EF between 11 and 25) or severe ED (IIEF-EF less than 11); 4) ED with a history of at least 3 months and less than 10 years; 5) Patients who did not use PDE5-I or other ED treatment methods within 2 weeks before grouping; 6) The patient voluntarily agreed to participate in this study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1) Secretory ED or neurogenic ED caused by severe endocrine disorders or sex hormone abnormalities; 2) Vascular ED caused by penile artery and cavernous lesions; 3) Any person with severe mental illness, spinal cord injury, abnormal penile anatomy, or penile hemangioma; 4) Poor blood pressure control in hypertensive patients (systolic blood pressure >= 160 mmHg and diastolic blood pressure >= 100 mmHg after treatment); 5) Diabetic blood glucose control was poor, and fasting plasma glucose (FPG) level was >7.0 mmol/l(126 mg/dl); 6) Clinically significant chronic diseases of the blood system, or severe respiratory, digestive and neurocentral diseases; 7) Patients who have had radical prostatectomy, pelvic surgery or radical prostate cancer surgery in the past; 8) Recovering from cancer in the past 1 year, or having undergone radiotherapy in the pelvic region; 9) Use anti-androgen and androgen drugs; Coagulation disorders and the use of anticoagulant agents (such as Coumadin) medicated ED; 10) Has participated in any other medical device or drug clinical investigator in the past 3 months; Or other patients whom the investigator considers inappropriate for the study.

Design outcomes

Primary

MeasureTime frame
IIEF-EF;

Secondary

MeasureTime frame
SEP;GAQ;EHS;Adverse Event;

Countries

China

Contacts

Public ContactShu-Jie Xia

Shanghai General Hospital

xsjurologist@163.com+86 15301655577

Outcome results

None listed

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