NCT02152683

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 11, 2022

Status Verified

September 1, 2015

Enrollment Period

1.4 years

First QC Date

May 22, 2014

Last Update Submit

August 8, 2022

Conditions

Vasculogenic Erectile Dysfunction

Outcome Measures

Primary Outcomes (3)

  • 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

  • IIEF-EF questionnaire score

    3 months post treatment

  • 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 Outcomes (3)

  • 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

Study Arms (2)

long protocol

EXPERIMENTAL

Renova

Device: Renova

short protocol

EXPERIMENTAL

Renova

Device: Renova

Interventions

RenovaDEVICE

Low- Intensity Shockwave

long protocolshort protocol

Eligibility Criteria

Age20 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hormonal, neurological or psychological pathology
  • Past radical prostatectomy or extensive pelvic surgery
  • Recovering from cancer during last year
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastchester Center for Cancer Care

New York, New York, 10469, United States

Location

Related Publications (4)

  • 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.

    PMID: 20451317BACKGROUND

  • 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.

    PMID: 22999553BACKGROUND

  • 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.

    PMID: 12152111BACKGROUND

  • 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.

    PMID: 21855209BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2014

First Posted

June 2, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 11, 2022

Record last verified: 2015-09

Locations

US(1)