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A clinical research about erectile dysfunction treated with low intensity pulsed ultrasound

An open-label, randomized controlled and multi-center study to investigate the efficacy and safety about the treatment of erectile dysfunction (ED) by using low intensity pulsed ultrasound with different doses.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023128
Enrollment
Unknown
Registered
2019-05-13
Start date
2019-05-14
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

Medium Dose:3 times a week
Low Dose:2 times a week

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 20-60 years old man 1. Healthy subject who have a stable heterosexual partner for more than 3 months; 2. Mild to moderate ED (IIEF-EF between 11 and 25); 3. At least 3 months and less than 10 years on history of ED ; 4. Those who did not use PDE5-i or other ED treatments within 2 weeks prior to grouping; 5. The patient agreed to participate in the study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. ED caused by to endocrine or abnormal sex hormones or neurogenic factors; 2. Vascular ED caused by lesions in penile artery and cavernous; 3. Anyone with severe mental illness, spinal cord injury, abnormal penis anatomy, or penile hemangioma; 4. Hypertension with poor blood pressure control (systolic blood pressure >= 160 mmHg and diastolic blood pressure >= 100 mmHg); 5. Diabetes with poor glycemic control, fasting plasma glucose (FPG) levels > 7.0 mmol / l (126 mg / dl); 6. Chronic blood system diseases, or severe respiratory, digestive, and central nervous diseases with clinical significance; 7. Patients who have undergone radical prostatectomy, pelvic surgery or radical prostatectomy in the past; 8. Who has been recovering from cancer in the past year or after undergoing radiotherapy in the pelvic region; 9. ED due to use of anti-androgen, androgen drugs; coagulation dysfunction and anticoagulant (such as Coumadin); 10. Have participated in any other medical device or clinical researcher in the past 3 months; or other patients who are considered unsuitable for participation in this trial.

Design outcomes

Secondary

MeasureTime frame
SEP;GAQ;EHS;Satisfaction score of erectile;SEAR;

Primary

MeasureTime frame
IIEF-EF;

Countries

China

Contacts

Public ContactXia Shujie, Li Zheng

Shanghai General Hospital

xsjurologist@163.com+86 13761258811

Outcome results

None listed

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