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Efficacy and Safety of Low-intensity Shock Wave Therapy for The Treatment of Mild to Moderate Erectile Dysfunction

Efficacy and Safety of E100 Shock Wave Therapy Sytem for The Treatment of Mild to Moderate Erectile Dysfunction

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020212
Enrollment
Unknown
Registered
2018-12-20
Start date
2019-01-21
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Erectile Dysfunction

Interventions

Group 1:LiESWT (Low-intensity Extracorporeal Shock Wave Therapy)
Group 2:Placebo Therapy

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Married males aged 22-65 have stable partners and regular sex life; (2) The IIEF EF score was 11-25; (3) In the past three months, ED was clinically diagnosed in the research center, and PDE5i was effective in the treatment of ED by oral administration under the doctor's prescription; (4) No treatment related to erectile dysfunction was used in the past two weeks; (5) Agree not to use treatment related to erectile dysfunction during the study period, such as PDE5i, androgen, Chinese patent medicine and physiotherapy; (6) Voluntary participation in this clinical trial, compliance with the requirements of this clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Severe ED patients with IIEF EF score less than 10 points; (2) According to the patient's medical history, physical examination and clinical auxiliary examination, the researchers diagnosed severe ED patients who were ineffective with oral PDE5i treatment; (3) Patients with bladder prostate cancer treated by surgery, radiotherapy, endocrine therapy and chemotherapy; (4) Patients with unstable mental disorders, brain and spine injuries, pelvic fractures and urethral injuries were treated surgically; (5) Patients with penile malformation, severe penile sclerosis and curvature; (6) Patients with acute or chronic hematological diseases and acute or chronic infections; (7) Acute and chronic urinary tract infection; (8) Patients with uncontrollable diabetes, hypertension and cardiovascular diseases; (9) Sex hormone examination indicated severe hyperprolactinemia and gonadal dysfunction; (10) Researchers decided that it was not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
IIEF-EF (International Index of Erectile Function-Erectile Function domain score);

Secondary

MeasureTime frame
EHS (Erection Hardness Score);SEP (Sexual Encounter Profile Questionnaire) Question2 & Question3;GAQ (Global Assessment Questions) Question1 & Question2;

Countries

China

Contacts

Public ContactXin Zhongcheng

Peking University First Hospital

xinzc@bjmu.edu.cn+86 13701305597

Outcome results

None listed

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