Linear Focused Shockwave Treatment for Erectile Dysfunction

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02152683

Enrollment

Registered

2014-06-02

Start date

2014-03-31

Completion date

2015-08-31

Last updated

2022-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasculogenic Erectile Dysfunction

Brief summary

The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols.

Interventions

DEVICERenova

Low- Intensity Shockwave

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Good general health 2. Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years. 3. International Index of Erectile Function 6 (IIEF-EF) between 17 and 25 4. Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors 5. Stable sexual relationship for at least 3 months prior to treatment 6. Minimum of two sexual attempts per month

Exclusion criteria

1. Hormonal, neurological or psychological pathology 2. Past radical prostatectomy or extensive pelvic surgery 3. Recovering from cancer during last year 4. Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities 5. Clinically significant chronic hematological disease 6. Anti-androgens, oral or injectable androgens 7. Past radiotherapy treatment of the pelvic region 8. International normalized ratio (INR) \> 3 for patients using blood thinners (such as Coumadin)

Design outcomes

Primary

Measure	Time frame	Description
IIEF-EF- International Index of Erectile Function questionnaire score	1 month post treatment	the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
IIEF-EF questionnaire score	3 months post treatment	—

Secondary

Measure	Time frame
SEP- Sexual Encounter Profile: Questions 2 and 3	1, 3 and 6 months post treatment
GAQ- Global Assessment Questions	1, 3 and 6 months post treatment
EHS- Erection Hardness Score	1, 3 and 6 months post treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026