Low Intensity Linear Shockwave Therapy for Erectile Dysfunction

NCT03843086 | Withdrawn

• 1 other identifier: 21221
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

MoreNovaED is a Linear Shockwaves (LISW) device in which shockwaves are focused onto line segments for improved organ coverage. Shockwaves produced by MoreNovaED are aimed at the left and right corpora cavernosa and the crura. The study is aimed at determining the safety and effectiveness of this new type LISW in the relief of ED.

Conditions

Vasculogenic Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• International Index of Erectile Function (IIEF-EF) Questionnaire

  The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials

  7 months

Secondary Outcomes (3)

• SEP (Sexual Encounter Profile) 2 & 3 at follow-ups

  7 months

• GAQ (Global Assessment Questions) at follow-ups

  7 months

• EHS (Erection Hardness Score) at follow-ups

  7 months

Study Arms (2)

720 Low Intensity shockwave therapy

ACTIVE COMPARATOR

Five daily sessions within a week, Monday thru Friday, in which 720 shocks of treatment energy applied every session to each treated region (left and right corpora cavernosa and crura)

Device: Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction

600 Low Intensity shockwaves therapy

ACTIVE COMPARATOR

Three weekly sessions for 2 consecutive weeks, Monday-Wednesday-Friday, in which 600 shocks of treatment energy applied every session to each treated region (left and right corpora cavernosa and crura) Following the last treatment session, each patient will resume his baseline consumption of phosphodiesterase 5 inhibitor in terms of type and dose of drug, for the remainder of study duration.

Device: Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction

Interventions

Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction DEVICE

This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients using low intensity shockwave therapy. The patients are randomized in a 1:1 ratio into two active treatment groups. Group A: 5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura). Group B: Three sessions per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)

Also known as: MoreNova

600 Low Intensity shockwaves therapy; 720 Low Intensity shockwave therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has been correctly informed about the study
• The patient must have given his informed and signed consent
• The patient is a man between 40 and 80 years of age
• The patient has ED of Vasculogenic origin
• The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
• The patient has been in a stable heterosexual relationship for over 3 months prior to enrollment
• A minimum of 2 sexual attempts per month for at least one month prior to enrollment
• The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years
• IIEF-EF score between 17 and 25
• Testosterone level 300-1000 ng/dL within 1 month prior to enrollment
• A1C level ≤ 7% within 1 month prior to enrollment
• Patients have at least a natural tumescence during sexual stimulation (EHS score ≥ 1).

You may not qualify if:

• The patient is participating in another study that may interfere with the results or conclusions of this study
• Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study
• The patient is under judicial protection
• The patient is an adult under guardianship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• History of radical prostatectomy or extensive pelvic surgery
• Venous leak
• Past radiation therapy of the pelvic region within 12 months prior to enrollment
• Recovering from cancer within 12 months prior to enrollment
• Neurological disease which effects erectile function
• Psychiatric disease which effects erectile function
• 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

Sponsors & Collaborators

• University of Virginia: lead
• DIREX SYSTEMS CORPORATION: collaborator

Study Officials

• Ryan P Smith, M.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 15, 2019
• Study Start: June 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05