Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction

NCT03067987 | Completed Results FDA Device

• 1 other identifier: 20160335
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Renova- Erectile Dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region. Shockwaves are aimed at the left and right corpora cavernosa and the crura. The study is aimed at determining the safety and effectiveness of this new type LISW in the relief of erectile dysfunction. HYPOTHESIS Alternate Hypothesis (HA): Active Treatment groups will show a \>2-point increase in the IIEF-EF score from baseline for mild erectile dysfunction, and \>5 points for moderate erectile dysfunction and will show significant change. Null Hypothesis (HO): There is no difference from baseline and after-treatment in Treatment groups for alleviating erectile dysfunction measured using International Index of Erectile Function score (IIEF-EF). Primary Efficacy Objective: To evaluate change of International Index of Erectile Function score Questionnaire score from baseline to follow-ups 1, 3 and 6 months' post treatment. Secondary Objectives:To study sexual activity improvement leading to optimal penetration at follow-ups according to:

• SEP- Sexual Encounter Profile Questionnaire.
• GAQ- Global Assessment Questionnaire.
• EHS- Erection Hardness Score.

Conditions

Vasculogenic Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• International Index of Erectile Function (IIEF-EF) Questionnaire

  IIEF is a 15 item self-administered questionnaire assessing erectile dysfunction and treatment outcomes. Total IIEF score range from 5-25 with scores classifying erectile dysfunction (ED) as: severe (5-7); moderate (8-11); mild to moderate (12-16); mild (17-21) and no ED (22-25). The questionnaire will be assessed at baseline (before 1 month washout prior to treatment initiation), 1 month follow up (at 2 months), 3 month follow up (at 4 months) and 6 months follow up (at 7 months). Time Frame: 7 months

  7 months

Secondary Outcomes (3)

• Erection Hardness Score (EHS)

  7 months

• Sexual Encounter Profile (SEP)

  7 months

• Global Assessment Question (GAQ)

  7 months

Study Arms (2)

720 shockwave therapy

ACTIVE COMPARATOR

5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).

Device: Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction.

600 shockwave therapy

ACTIVE COMPARATOR

Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura) Following the last treatment session, each patient will resume his baseline consumption of phosphodiesterase 5 inhibitor, in terms of type and dose of drug, for the remainder of study duration.

Device: Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction.

Interventions

Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction. DEVICE

This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients. The patients are randomized in a 1:1 ratio into two active treatment groups. Group A: 5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura). Group B: Three sessions per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura) .

Also known as: RENOVA-ED

600 shockwave therapy; 720 shockwave therapy

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be willing and able to provide informed consent.
• The patient is a male between \>30 and \<80 years of age.
• PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication for 4 weeks before IIEF.
• Stable sexual relationship for over 3 months prior to enrollment.
• A minimum of 2 sexual attempts per month for at least one month prior to enrollment.
• Erectile dysfunction lasting for over 6 months and not more than 5 years.
• Baseline IIEF-EF score between 11 and 25. If taking PDE5i, stop medication for at least 4 weeks before baseline IIEF-EF.
• Testosterone level 300-1000 ng/dL.
• If diabetic, HgbA1C level ≤ 7.5% within 1 month prior to enrollment.

You may not qualify if:

• The patient is currently or has participated in another study within the past three months, that may interfere with the results or conclusions of this study.
• The patient is under judicial protection (prison or custody).
• The patient is an adult under guardianship.
• The patient refuses to sign the consent.
• History of radical prostatectomy or extensive pelvic surgery ever.
• Past radiation therapy of the pelvic region within 12 months prior to enrollment.
• Recovering from any cancer within 12 months prior to enrollment.
• Neurological disease such as Alzheimers or Parkinsons disease which affects erectile function at the discretion of the investigator.
• Psychiatric diagnosis or medications such as antidepressants which affects erectile function or any other medications at the discretion of the investigator.
• Anatomical malformation of the penis, including Peyronie's disease.
• Testosterone level \<300 or \>1000 ng/dL within 1 month prior to enrollment.
• HgbA1C level \> 7.5% within 1 month prior to enrollment.
• Androgen deprivation treatment in the last year.
• History of spinal cord injury.
• The patient is taking blood thinners (eg Coumadin, Plavix)

Sponsors & Collaborators

• University of Miami: lead
• DIREX SYSTEMS CORPORATION: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (11)

• Mulhall JP. Defining and reporting erectile function outcomes after radical prostatectomy: challenges and misconceptions. J Urol. 2009 Feb;181(2):462-71. doi: 10.1016/j.juro.2008.10.047. Epub 2008 Dec 13.

  PMID: 19084865 BACKGROUND

• Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.

  PMID: 9187685 BACKGROUND

• 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: 22425129 BACKGROUND

• 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: 20451317 BACKGROUND

• Wang CJ, Kuo YR, Wu RW, Liu RT, Hsu CS, Wang FS, Yang KD. Extracorporeal shockwave treatment for chronic diabetic foot ulcers. J Surg Res. 2009 Mar;152(1):96-103. doi: 10.1016/j.jss.2008.01.026. Epub 2008 Mar 7.

  PMID: 18619622 BACKGROUND

• Rompe JD, Rumler F, Hopf C, Nafe B, Heine J. Extracorporal shock wave therapy for calcifying tendinitis of the shoulder. Clin Orthop Relat Res. 1995 Dec;(321):196-201.

  PMID: 7497669 BACKGROUND

• Haupt G, Haupt A, Ekkernkamp A, Gerety B, Chvapil M. Influence of shock waves on fracture healing. Urology. 1992 Jun;39(6):529-32. doi: 10.1016/0090-4295(92)90009-l.

  PMID: 1615601 BACKGROUND

• Kikuchi Y, Ito K, Ito Y, Shiroto T, Tsuburaya R, Aizawa K, Hao K, Fukumoto Y, Takahashi J, Takeda M, Nakayama M, Yasuda S, Kuriyama S, Tsuji I, Shimokawa H. Double-blind and placebo-controlled study of the effectiveness and safety of extracorporeal cardiac shock wave therapy for severe angina pectoris. Circ J. 2010 Mar;74(3):589-91. doi: 10.1253/circj.cj-09-1028. Epub 2010 Feb 4.

  PMID: 20134096 BACKGROUND

• Melman A, Gingell JC. The epidemiology and pathophysiology of erectile dysfunction. J Urol. 1999 Jan;161(1):5-11.

  PMID: 10037356 BACKGROUND

• Vlachopoulos C, Rokkas K, Ioakeimidis N, Aggeli C, Michaelides A, Roussakis G, Fassoulakis C, Askitis A, Stefanadis C. Prevalence of asymptomatic coronary artery disease in men with vasculogenic erectile dysfunction: a prospective angiographic study. Eur Urol. 2005 Dec;48(6):996-1002; discussion 1002-3. doi: 10.1016/j.eururo.2005.08.002. Epub 2005 Aug 24.

  PMID: 16174548 BACKGROUND

• Katz JE, Molina ML, Clavijo R, Prakash NS, Ramasamy R. A Phase 2 Randomized Trial To Evaluate Different Dose Regimens of Low-intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction: Clinical Trial Update. Eur Urol Focus. 2018 Apr;4(3):336-337. doi: 10.1016/j.euf.2018.07.011. Epub 2018 Jul 17.

  PMID: 30025713 DERIVED

Results Point of Contact

• Title: Ranjith Ramasamy
• Organization: University of Miami

ramasamy@miami.edu

3052434873

Study Officials

• Ranjith Ramasamy, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist/ Director of Male Reproductive Medicine/ Assistant professor Urology Department University of Miami

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 1, 2017
• Study Start: February 22, 2017
• Primary Completion: May 22, 2019
• Study Completion: May 28, 2019
• Last Updated: June 11, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)