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

NCT03670628 | Terminated Results FDA Device

• 2 other identifiers: 2018065120181840
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.

  The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.

  Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

Secondary Outcomes (2)

• Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire

  Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

• Erection Hardness Score (EHS)

  Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

Study Arms (2)

720 shockwave therapy Group

ACTIVE COMPARATOR

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)

Device: Shockwave therapy

Sham shockwave therapy

SHAM COMPARATOR

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).

Other: Sham shockwave therapy

Interventions

Shockwave therapy DEVICE

Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)

720 shockwave therapy Group

Sham shockwave therapy OTHER

Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base)

Sham shockwave therapy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Ranjith Ramasamy, MD
• Organization: University of Miami, Miller School of Medicine - Desai Sethi Urology Institute

ramasamy@miami.edu

305-243-4562

Study Officials

• Ranjith Ramasamy, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Male Fertility/ Andrology department

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 13, 2018
• Study Start: May 1, 2019
• Primary Completion: November 12, 2021
• Study Completion: November 12, 2021
• Last Updated: July 10, 2023
• Results First Posted: July 10, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)