Skip to content

Efficacy and safety of MDT-based low-intensity pulsed ultrasound in the treatment of diabetic erectile dysfunction: a multicenter randomized controlled study

Efficacy and safety of MDT-based low-intensity pulsed ultrasound in the treatment of diabetic erectile dysfunction: a multicenter randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062003
Enrollment
Unknown
Registered
2022-07-17
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Diabetes mellitus-induced erectile dysfunction

Interventions

Experimental group:The experimental group was treated with low-intensity pulsed ultrasound (LIPUS), the frequency was 3 times a week, and 12 treatments were completed in 4 weeks.
Control group:The control group did not receive LIPUS treatment, only the patients in this group were given diabetes-related management and counseling, counseling by the psychiatry department, and hea

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age 20-60 years old, male; 2. General health, with stable heterosexual partners for more than 3 months; 3. Diabetes diagnosed by the endocrinology department; 4. Diagnosed as ED by nocturnal erectile rigidity (NPTR) test; 5. No PDE5-i or other ED treatment was used within 2 weeks before grouping; 6. The patients voluntarily agreed to participate in this study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. ED caused by serious neurological or serious psycho-psychological factors; 2. Those who have previously undergone radical prostatectomy, pelvic surgery or radical prostatectomy and other surgeries affecting erectile function; 3. Any unstable medical, spinal cord injury, abnormal penis anatomy; 4. Those with obstruction of the penile artery or cavernous artery; 5. Those who are recovering from cancer in the past year; 6. Clinically significant chronic blood system diseases, or severe respiratory, digestive, and central nervous system diseases; 7. Those who have confirmed penile hemangioma or cavernous fibrosis; 8. Patients with hypertension with poor blood pressure control (systolic blood pressure =160mmHg and or diastolic blood pressure =100mmHg after treatment); 9. Use of anti-androgens and androgen drugs; 10. Postoperative radiotherapy in the pelvic region; 11. Patients with coagulation disorders and using anticoagulants; 12. Have participated in any other medical device or drug clinical research within the past 3 months; 13. Patients deemed unsuitable for participation in this trial by other investigators.

Design outcomes

Primary

MeasureTime frame
Nocturnal Penile Tumescence and Rigidity;

Secondary

MeasureTime frame
Penile angiography and penile electrophysiology;International Index of Erectile Function(IIEF-EF) score;

Countries

China

Contacts

Public ContactXiaoqiang Liu

Tianjin Medical University General Hospital

xiaoqiangliu1@163.com+86 13820915038

Outcome results

None listed

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