Linear Focused Shockwave Treatment for Erectile Dysfunction

Not Applicable

Terminated

• Conditions: Vasculogenic Erectile Dysfunction
• Interventions: Device: Renova

• Registration Number: NCT02152683
• Lead Sponsor: Initia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-06-02
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Disposition First Submitted: 2022-08-08
• Disposition First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Disposition First Posted: 2022-08-11
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 84

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
short protocol	Renova	Renova
long protocol	Renova	Renova

Primary Outcome Measures

Name	Time	Method
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	6 months post treatment	the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Eastchester Center for Cancer Care; 🇺🇸 New York, New York, United States