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A multicenter, randomized, double-blind, blank-controlled trial of the safety and efficacy of linear shock wave treatment for vascular erectile dysfunction (ED)

A multicenter, randomized, double-blind, blank-controlled trial of the safety and efficacy of linear shock wave treatment for vascular erectile dysfunction (ED)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17014019
Enrollment
Unknown
Registered
2017-12-18
Start date
2015-06-27
Completion date
Unknown
Last updated
2018-01-29

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

Conditions

Erectile Dysfunction

Interventions

treatment group:normal energy shock wave threapy 4locations per cycle, 4 cycles in 4 weeks
Control group:Routine treatment

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Aged 20-70 years old male; 2) Healthy in general; 3) in line with the diagnosis of vascular erectile dysfunction (ED); 4) have a history of ED for at least 6 months, and no more than 7 years; 5) Past user of PDE5-i and take effective; 6) did not use PDE5-i within 4 weeks prior to grouping; 7) IIEF-EF scoure between 11 and 25; 8) a stable heterosexual relationship for at least 3 months before treatment; 9) Subject voluntarily agreed to participate in the trial and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) ED due to hormonal, neurological or psychopathological factors; 2) patients who have got radical prostatectomy or pelvic surgery in the past; 3) any unstable medical, mental illness, spinal cord injury, abnormal penis anatomy; 4) Arterial obstruction is located in the common penile artery and cavernosal artery; 5) The penis is implanted in the prosthesis; 6) recovering from cancer in the past year; 7) clinically significant chronic hematological diseases; 8) venous leak has been confirmed; 9) poor blood pressure control (systolic blood pressure after treatment = 160mmHg and diastolic blood pressure = 100mmHg); 10) poor glycemic control after treatment, FPG after treatment> 7.0 mmol / l (126 mg / dl); 11) anti-androgens, either orally or injection; 12) pelvic radiotherapy postoperation; 13) Coagulation disorders and use of anticoagulants such as Coumadin; 14) Have participated in any other medical device or drug clinical research in the past three months; 15) Patients unsuitable for this trial.

Design outcomes

Primary

MeasureTime frame
IIEF-EF;Pain;ERY, LEU, PRO, GLU;hematoma;hematuria;Ecchymosis;

Secondary

MeasureTime frame
SEP;GAQ;EHS;BUN, CR;glucose;X-ray;RBC, WBC, NEUT, HGB, PLT;AST, ALT, GGT;ECG;

Countries

China

Contacts

Public ContactXin Zhongcheng

Peking University 1st Hospital

xinzc@bjmu.edu.cn+86 13701305597

Outcome results

None listed

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