NCT03067987

Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction

Completed NA Results posted Last updated 11 June 2020

What this trial tests

NA trial testing Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction. in Vasculogenic Erectile Dysfunction in 103 participants. Completed in 28 May 2019.

Timeline

22 February 2017

Primary endpoint
22 May 2019

28 May 2019

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	103
Start date	22 February 2017
Primary completion	22 May 2019
Estimated completion	28 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction.

Conditions studied

• Vasculogenic Erectile Dysfunction — all drugs for Vasculogenic Erectile Dysfunction →

Sponsor

University of Miami

Who can join

Adults 30 to 80, male only, with Vasculogenic Erectile Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

International Index of Erectile Function (IIEF-EF) Questionnaire Primary · 7 months

IIEF is a 15 item self-administered questionnaire assessing erectile dysfunction and treatment outcomes. Total IIEF score range from 5-25 with scores classifying erectile dysfunction (ED) as: severe (5-7); moderate (8-11); mild to moderate (12-16); mild (17-21) and no ED (22-25). The questionnaire will be assessed at baseline (before 1 month washout prior to treatment initiation), 1 month follow up (at 2 months), 3 month follow up (at 4 months) and 6 months follow up (at 7 months). Time Frame: 7 months

SCORE AT BASELINE

Group	Value	95% CI
720 Shockwave Therapy	18	11 – 25
600 Shockwave Therapy	17.9	11 – 25

SCORE AT 1 MONTHS

Group	Value	95% CI
720 Shockwave Therapy	20.5	11 – 25
600 Shockwave Therapy	19.7	11 – 25

SCORE AT 3MONTHS

Group	Value	95% CI
720 Shockwave Therapy	19.8	11 – 25
600 Shockwave Therapy	21.2	11 – 25

SCORE AT 6 MONTHS

Group	Value	95% CI
720 Shockwave Therapy	20.9	11 – 25
600 Shockwave Therapy	21.4	11 – 25

Erection Hardness Score (EHS) Secondary · 7 months

EHS rates the hardness of erection on a scale of 1-4 assessed at baseline (before 1 month washout prior to treatment initiation), 1 month follow up (at 2 months), 3 month follow up (at 4 months) and 6 months follow up (at 7 months). A score of 0 = penis does not enlarge; 1 = penis is larger but not hard; 2 = penis is hard but not hard enough for penetration; 3 = penis is hard enough for penetration but not completely hard; 4 = penis is completely hard and fully rigid.

SCORE AT BASELINE

Group	Value	95% CI
720 Shockwave Therapy	2.5	0 – 4
600 Shockwave Therapy	2.7	0 – 4

SCORE AT 1 MONTH

Group	Value	95% CI
720 Shockwave Therapy	3.1	0 – 4
600 Shockwave Therapy	3	0 – 4

SCORE AT 3 MONTHS

Group	Value	95% CI
720 Shockwave Therapy	3.1	0 – 4
600 Shockwave Therapy	3	0 – 4

SCORE AT 6 MONTHS

Group	Value	95% CI
720 Shockwave Therapy	3.1	0 – 4
600 Shockwave Therapy	3.2	0 – 4

Sexual Encounter Profile (SEP) Secondary · 7 months

Sexual Encounter Profile (SEP) is a measure of efficacy of erectile dysfunction therapy. Improved responses to treatment will be reported as the percentage of participants that responds "yes" and non-improvement responses to treatment will be reported as the percentage of participants that responds "no".

SEP-Q2 (YES)

Group	Value	95% CI
720 Shockwave Therapy	96
600 Shockwave Therapy	95

SEP-Q2 (NO)

Group	Value	95% CI
720 Shockwave Therapy	4
600 Shockwave Therapy	5

SEP-Q3 (YES)

Group	Value	95% CI
720 Shockwave Therapy	69
600 Shockwave Therapy	70

SEP-Q3 (NO)

Group	Value	95% CI
720 Shockwave Therapy	31
600 Shockwave Therapy	30

Global Assessment Question (GAQ) Secondary · 7 months

Global Assessment Question (GAQ) is a measure of perceived improvements in erectile function and sexual ability. Improved responses to treatment will be reported as the percentage of participants that responds "yes" and non-improvement responses to treatment will be reported as the percentage of participants that responds "no".

GAQ-Q1 (YES)

Group	Value	95% CI
720 Shockwave Therapy	52
600 Shockwave Therapy	53

GAQ-Q1 (NO)

Group	Value	95% CI
720 Shockwave Therapy	48
600 Shockwave Therapy	47

GAQ-Q2 (YES)

Group	Value	95% CI
720 Shockwave Therapy	74
600 Shockwave Therapy	73

GAQ-Q2(NO)

Group	Value	95% CI
720 Shockwave Therapy	26
600 Shockwave Therapy	27

Sponsor's own description

Renova- Erectile Dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region. Shockwaves 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 erectile dysfunction.

HYPOTHESIS Alternate Hypothesis (HA): Active Treatment groups will show a \>2-point increase in the IIEF-EF score from baseline for mild erectile dysfunction, and \>5 points for moderate erectile dysfunction and will show significant change.

Null Hypothesis (HO): There is no difference from baseline and after-treatment in Treatment groups for alleviating erectile dysfunction measured using International Index of Erectile Function score (IIEF-EF).

Primary Efficacy Objective: To evaluate change of International Index of Erectile Function score Questionnaire score from baseline to follow-ups 1, 3 and 6 months' post treatment.

Secondary Objectives:To study sexual activity improvement leading to optimal penetration at follow-ups according to:

* SEP- Sexual Encounter Profile Questionnaire.
* GAQ- Global Assessment Questionnaire.
* EHS- Erection Hardness Score.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Phase II Randomized, Clinical Trial Evaluating 2 Schedules of Low-Intensity Shockwave Therapy for the Treatment of Erectile Dysfunction.
   Patel P, Katz J, Lokeshwar SD, Molina M, et al · · 2020 · cited 14× · PMID 32184082 · DOI 10.1016/j.esxm.2020.01.010