Linear Focused Shockwave Treatment for Erectile Dysfunction

Vasculogenic Erectile Dysfunction Clinical Trial

Official title:

Linear Focused Shockwave Treatment for Erectile Dysfunction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02152683
• Other study ID #: LISW-NY
• Status: Terminated
• Phase: N/A
• Start date: March 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Initia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Erectile Dysfunction
• Vasculogenic Erectile Dysfunction

Intervention

Device:
• Renova
Low- Intensity Shockwave

Locations

Country	Name	City	State
United States	Eastchester Center for Cancer Care	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Initia

Country where clinical trial is conducted

United States, 

References & Publications (4)

Goyal NK, Garg M, Goel A. Re: Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study: Y. Vardi, B. Appel, A. Kilchevsky and I. Gruenwald. J Urol 2012; 187: 1769-1775. J Urol. 2012 Nov;188(5):2018-9. doi: 10.1016/j.juro.2012.07.052. Epub 2012 Sep 20. — View Citation

Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30. — View Citation

Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res. 2002 Aug;14(4):226-44. Review. — View Citation

Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IIEF-EF- International Index of Erectile Function questionnaire score	the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment	1 month post treatment
Primary	IIEF-EF questionnaire score		3 months post treatment
Primary	IIEF-EF questionnaire score	the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment	6 months post treatment
Secondary	SEP- Sexual Encounter Profile: Questions 2 and 3		1, 3 and 6 months post treatment
Secondary	GAQ- Global Assessment Questions		1, 3 and 6 months post treatment
Secondary	EHS- Erection Hardness Score		1, 3 and 6 months post treatment