Clinical trial NCT01811797: Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova
Official title: A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy Associated With Treating Patients Suffering From Erectile Dysfunction With Low Intensity Shockwaves by Renova
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vasculogenic Erectile Dysfunction
Keywords: Erectile Dysfunction
Extracorporeal shockwave
Low intensity shockwaves
Lead sponsor: Initia
Sponsor class: INDUSTRY
First posted: 2013-03-15
Enrollment: 2
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.


Eligibility criteria: Inclusion Criteria:

* Good general health
* Vascular ED for at least 6 months
* International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
* Positive response to PDE5-I (able to penetrate on demand=Responders)
* Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage = Non-responders)
* Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 3 and 6 months post treatment
timeFrame: 1, 3 and 6 months post treatment
Secondary outcomes:
measure: Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 3 and 6 months post treatment
timeFrame: 1, 3 and 6 months post treatment
measure: Change from baseline in the GAQ (Global Assessment Questions) at 3 and 6 months post treatment
timeFrame: 1, 3 and 6 months post treatment
measure: Change from baseline in the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment
timeFrame: 1, 3 and 6 months post treatment
measure: Change from baseline in the Partner EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment
timeFrame: 1, 3 and 6 months post treatment
measure: Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment
timeFrame: 0 and 6 months post treatment
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: The Tel-Aviv Sourasky Medical Center
Study officials:
References:
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.
citation: Vardi Y, Appel B, Kilchevsky A, Gruenwald I. 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. J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15.
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. doi: 10.1038/sj.ijir.3900857.
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.