Clinical trial NCT02152683: Linear Focused Shockwave Treatment for Erectile Dysfunction
Official title: Linear Focused Shockwave Treatment for Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vasculogenic Erectile Dysfunction
Lead sponsor: Initia
Sponsor class: INDUSTRY
First posted: 2014-06-02
Enrollment: 84
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: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: IIEF-EF- International Index of Erectile Function questionnaire score
timeFrame: 1 month post treatment
measure: IIEF-EF questionnaire score
timeFrame: 3 months post treatment
measure: IIEF-EF questionnaire score
timeFrame: 6 months post treatment
Secondary outcomes:
measure: SEP- Sexual Encounter Profile: Questions 2 and 3
timeFrame: 1, 3 and 6 months post treatment
measure: GAQ- Global Assessment Questions
timeFrame: 1, 3 and 6 months post treatment
measure: EHS- Erection Hardness Score
timeFrame: 1, 3 and 6 months post treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Eastchester Center for Cancer Care
state: New York
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: 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. No abstract available.
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.