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N/A N=80 Randomized Double-blind Treatment

Radial Shockwave Therapy for Erectile Dysfunction

Erectile Dysfunction

Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Change IIEF-EF Score — 3.4; 4.2 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Radial wave therapy (Device); Placebo therapy (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
Boston Medical Group
Primary completion
Mar 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Change IIEF-EF Score
3.4; 4.2
SECONDARY
IIEF-EF Score After One Month of Follow-up
0.72; 2.3
SECONDARY
Erection Hardness Score (EHS)
15; 14

Summary

Objective: To evaluate the efficacy and safety of radial shock waves for the treatment of erectile dysfunction [ED]. Patients and methods: Randomized, double-blind clinical trial. The study will include patients of legal age with diagnosis of ED and score on the International Index of Erectile Function [IIEF-EF] scale between 11 and 21 points, who voluntarily decide to participate and sign the informed consent. Patients with bladder cancer, prostate cancer or active colon, ED of psychological origin, any psychiatric disorder, spinal cord injury, clinical suspicion of hypogonadism (score on the Aging Males' Symptoms scale greater than 36), infections or active lesions of the penis or pubic area, ED secondary to treatment with medications (antiandrogenic therapy, use of corticosteroids, anti-Parkinson's, antipsychotics), radical prostatectomy or other radical pelvic surgery, history of pelvic radiotherapy, penile implantation, or endocrine diseases that occur with ED (acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgenic deficiency), sickle cell anemia, and anticoagulated patients will be excluded. Patients will be randomly assigned to one of the following treatment arms: * Arm 1 (Standard treatment (oral sildenafil) + Radial wave therapy) * Arm 2 (Standard treatment (oral sildenafil) + Placebo therapy) Measurements will be made of the Erection Hardness Score [EHS] and IIEF-EF scale scores, of the use of medication and of the possible adverse events of the therapy, at the beginning and end of the treatment, and one month after the therapies are finished.

Eligibility Criteria

Inclusion Criteria

  • Men older than 18 years
  • Erectile dysfunction present more for more than 3 months in more than 50% of intercourse.
  • IIEF-EF score between 11 and 21.
  • Patient who agrees to enter the study through the signing of an informed consent.

Exclusion Criteria

  • EHS score of 4
  • Bladder, prostate or colon cancer.
  • ED of psychological origin.
  • Patients with spinal cord injury.
  • Patients with anticoagulant use.
  • Patients with sickle cell anemia.
  • Patients with clinical suspicion of hypogonadism (AMS greater than 36, Annex 1).
  • Patients with infections or active lesions of the penis or pubic area.
  • Patients with ED secondary to drug treatment (antiandrogenic therapy, antidepressants, use of corticosteroids, antiparkinsonians, antipsychotics).
  • Radical prostatectomy or other radical pelvic surgery.
  • Antecedents of pelvic radiotherapy.
  • Patients with penile implant.
  • Endocrine diseases that occur with ED: acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgenic deficiency.
  • Patients with neurological diseases (Parkinson's, CVD, dementia of any origin)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03596047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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