NCT02683044

Brief Summary

Randomized, experimental, non-inferiority clinical trial to determine the comparative effectiveness and safety of two protocols used in the treatment of Erectile Dysfunction (ED) with Low-Density Shock Waves (Li-ESWT), for patients seen at the Boston Medical Group's Bogota center. Protocol 1: Consists of five sessions, one per week, with 3000 pulses at 0,15 mg/mm2, at a frequency of 4 Hz. The distribution of the shocks will be 2000 pulses to the body of the penis and 1000 pulses at its base. Total duration: 5 weeks. Protocol 2: Consists of six sessions, two per week, with 1500 pulses each one at 0.1 mJ/mm2, at a frequency of 4 Hz. The distribution of the shocks will be 900 pulses to the body of the penis and 600 pulses at its base. Total duration: 3 weeks. Outcome variables: Erection Hardness Score (EHS). International Index of Erectile Function, 5-item version (IIEF-5). Penile blood flow. Evaluation at 1, 3 and 6 months after completing each of the Li-ESWT protocols.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

February 9, 2016

Last Update Submit

July 15, 2016

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunctionLow-Density Shock WavesRandomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

  • Erection Hardness Score (EHS)

    1 month after completing each protocol

Secondary Outcomes (3)

  • Penile blood flow

    1 month after completing each protocol

  • International Index of Erectile Function, 5-item version (IIEF-5)

    1, 3 and 6 months after completing each protocol

  • Erection Hardness Score (EHS)

    3 and 6 months after completing each protocol

Study Arms (2)

Li-ESWT 5 weeks

EXPERIMENTAL

Consists of five sessions of Low-Intensity Extracorporeal Shock Wave Therapy , one per week, with 3000 pulses at 0,15 mg/mm2, at a frequency of 4 Hz. The distribution of the shocks will be 2000 pulses to the body of the penis and 1000 pulses at its base. Total duration: 5 weeks.

Procedure: Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT)

Li-ESWT 3 weeks

ACTIVE COMPARATOR

Consists of six sessions of Low-Intensity Extracorporeal Shock Wave Therapy , two per week, with 1500 pulses each one at 0.1 mJ/mm2, at a frequency of 4 Hz. The distribution of the shocks will be 900 pulses to the body of the penis and 600 pulses at its base. Total duration: 3 weeks.

Procedure: Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT)

Interventions

Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT)PROCEDURE

Sessions of shocks to the body of the penis

Li-ESWT 3 weeksLi-ESWT 5 weeks

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of ED for more than 3 months in over 50% of sexual intercourses.
  • EHS score under or equal to 3.
  • IIEF-5 score under or equal to 21.
  • Patients who agree to participate in the trial through signed informed consent.

You may not qualify if:

  • Active bladder, prostate or colon cancer.
  • Patients with ED having a psychological origin.
  • Any psychiatric pathology, spinal cord injury or anatomical penile dysfunction.
  • Patients with INR over 3, ordered by a cardiologist.
  • Patients with clinically suspected hypogonadism (AMS under 36).
  • Patients with active infections or lesions on the penis or pubic area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Group

Bogotá, Bogota D.C., 111321, Colombia

RECRUITING

Related Publications (13)

  • Rosen RC, Fisher WA, Eardley I, Niederberger C, Nadel A, Sand M; Men's Attitudes to Life Events and Sexuality (MALES) Study. The multinational Men's Attitudes to Life Events and Sexuality (MALES) study: I. Prevalence of erectile dysfunction and related health concerns in the general population. Curr Med Res Opin. 2004 May;20(5):607-17. doi: 10.1185/030079904125003467.

    PMID: 15171225BACKGROUND

  • Lewis RW, Fugl-Meyer KS, Corona G, Hayes RD, Laumann EO, Moreira ED Jr, Rellini AH, Segraves T. Definitions/epidemiology/risk factors for sexual dysfunction. J Sex Med. 2010 Apr;7(4 Pt 2):1598-607. doi: 10.1111/j.1743-6109.2010.01778.x.

    PMID: 20388160BACKGROUND

  • Braun M, Wassmer G, Klotz T, Reifenrath B, Mathers M, Engelmann U. Epidemiology of erectile dysfunction: results of the 'Cologne Male Survey'. Int J Impot Res. 2000 Dec;12(6):305-11. doi: 10.1038/sj.ijir.3900622.

    PMID: 11416833BACKGROUND

  • McKinlay JB. The worldwide prevalence and epidemiology of erectile dysfunction. Int J Impot Res. 2000 Oct;12 Suppl 4:S6-S11. doi: 10.1038/sj.ijir.3900567.

    PMID: 11035380BACKGROUND

  • Nicolosi A, Glasser DB, Kim SC, Marumo K, Laumann EO; GSSAB Investigators' Group. Sexual behaviour and dysfunction and help-seeking patterns in adults aged 40-80 years in the urban population of Asian countries. BJU Int. 2005 Mar;95(4):609-14. doi: 10.1111/j.1464-410X.2005.05348.x.

    PMID: 15705089BACKGROUND

  • Yee CH, Chan ES, Hou SS, Ng CF. Extracorporeal shockwave therapy in the treatment of erectile dysfunction: a prospective, randomized, double-blinded, placebo controlled study. Int J Urol. 2014 Oct;21(10):1041-5. doi: 10.1111/iju.12506. Epub 2014 Jun 17.

    PMID: 24942563BACKGROUND

  • Zhao C, Kim SW, Yang DY, Kim JJ, Park NC, Lee SW, Paick JS, Ahn TY, Moon KH, Chung WS, Min KS, Suh JK, Hyun JS, Park K, Park JK. Efficacy and safety of avanafil for treating erectile dysfunction: results of a multicentre, randomized, double-blind, placebo-controlled trial. BJU Int. 2012 Dec;110(11):1801-6. doi: 10.1111/j.1464-410X.2012.11095.x. Epub 2012 Mar 27.

    PMID: 22448738BACKGROUND

  • 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.

    PMID: 22425129BACKGROUND

  • 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

  • Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.

    PMID: 8254833BACKGROUND

  • Gruenwald I, Appel B, Vardi Y. Low-intensity extracorporeal shock wave therapy--a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med. 2012 Jan;9(1):259-64. doi: 10.1111/j.1743-6109.2011.02498.x. Epub 2011 Oct 18.

    PMID: 22008059BACKGROUND

  • Aicher A, Heeschen C, Sasaki K, Urbich C, Zeiher AM, Dimmeler S. Low-energy shock wave for enhancing recruitment of endothelial progenitor cells: a new modality to increase efficacy of cell therapy in chronic hind limb ischemia. Circulation. 2006 Dec 19;114(25):2823-30. doi: 10.1161/CIRCULATIONAHA.106.628623. Epub 2006 Dec 4.

    PMID: 17145991BACKGROUND

  • Lei H, Liu J, Li H, Wang L, Xu Y, Tian W, Lin G, Xin Z. Low-intensity shock wave therapy and its application to erectile dysfunction. World J Mens Health. 2013 Dec;31(3):208-14. doi: 10.5534/wjmh.2013.31.3.208. Epub 2013 Dec 24.

    PMID: 24459653BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jose P Saffon, MD

    Boston Medical Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hector A Corredor, MD

CONTACT

57-1-7431857hcorredor@bostonmedical.com.co

Study Design

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

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 17, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

July 18, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)