NCT02005731

Brief Summary

This is a prospective, pilot study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

Geographic Reach
4 countries

4 active sites

Status
completed

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

November 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
Last Updated

June 11, 2014

Status Verified

June 1, 2014

Enrollment Period

1 year

First QC Date

December 4, 2013

Last Update Submit

June 10, 2014

Conditions

Vasculogenic Erectile Dysfunction

Keywords

Low Intensity ShockwaveExtracorporeal shockwave therapyErectile dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 3 and 6 months post treatment

    1, 3 and 6 months post treatment

Secondary Outcomes (2)

  • Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 1, 3 and 6 months post treatment

    1, 3 and 6 months post treatment

  • Responses to the GAQ (Global Assessment questions) Questions 1 and 2 at 1, 3 and 6 months post treatment

    1, 3 and 6 months post treatment

Study Arms (1)

Shockwaves

Low intensity linear focused shockwave device ('Renova')

Device: Low intensity linear focused shockwave device ('Renova')

Interventions

Low intensity linear focused shockwave device ('Renova')DEVICE
Shockwaves

Eligibility Criteria

Age20 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sexual Medicine clinic

You may qualify if:

  • Good general health
  • Vasculogenic 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

You may not qualify if:

  • Psychogenic ED
  • Neurological pathology
  • Hormonal pathology
  • Past radical prostatectomy
  • 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
  • Radiotherapy in pelvic region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Urologickaambulance

Brno, Czechia

Location

Amber Clinic

Klaipėda, Lithuania

Location

Men's Health Clinic, Amstelland Hospital

Amsterdam, Netherlands

Location

Urology and Andrology Center, Red Crescent Hospital (RCH)

Ramallah, Palestinian Territories

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

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Cobi Reisman, MD, PhD

    Men's Health Clinic, Amstelland Hospital, Amsterdam, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 9, 2013

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

June 11, 2014

Record last verified: 2014-06

Locations

CZ(1)LI(1)NL(1)PA(1)