Low Intensity Shockwaves Therapy for the Treatment of Erectile Dysfunction. 12- Month Follow-Up

University of Miami

Status: Terminated

Conditions: Erectile Dysfunction

Treatments: Device: Shockwave therapy; Other: Sham shockwave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03670628

20180651

20181840 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.

Enrollment: 23 patients

Sex: Male

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must be able willing and able to provide informed consent.
• The patient is a male between 30 and 70 years of age (inclusive).
• The patient has erectile dysfunction (ED) based of IIEF scores.
• The patient has been in a stable relationship for over 3 months prior to enrollment.
• A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by International Index of Erectile Dysfunction (IIEF)
• The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient.
• IIEF-EF score between 16 and 25.
• Testosterone level 300-1000 ng/dL within 1 month prior to enrollment. A1C level ≤ 7% within 1 month prior to enrollment

Exclusion criteria

• The patient is currently or has participated in another study within the past three months that may interfere with the results or conclusions of this study.
• The patient is under judicial protection (prison or custody).
• The patient is an adult under guardianship.
• The patient refuses to sign the consent.
• History of radical prostatectomy or extensive pelvic surgery.
• Evidence of venous leak.
• Past radiation therapy of the pelvic region within 12 months prior to enrollment.
• Recovering from any cancer within 12 months prior to enrollment.
• Neurological disease such as Alzheimers or Parkinson's disease which affects erectile function at the discretion of the investigator.
• Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator.
• Anatomical malformation of the penis, including Peyronie's disease.
• Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
• A1C level > 7% within 1 month prior to enrollment or history of Insulin dependent diabetes.
• The patient is taking blood thinners and has an international normalized ratio >3.
• Received shockwave treatment at least 6 months before enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

23 participants in 2 patient groups

720 shockwave therapy Group

Active Comparator group

Description:

Participants in this group will receive a total of 5 daily sessions of shockwave therapy within a week. Each therapy session will consist of 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)

Treatment:

Device: Shockwave therapy

Sham shockwave therapy

Sham Comparator group

Description:

Participants in this group will receive a total of 5 daily sessions of sham shockwave therapy within a week. Sham therapy will be applied to the penis and to the left and right crus (shaft near the base).

Treatment:

Other: Sham shockwave therapy