Randomized Control Trial of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction. 12- Month Follow-Up of a Double-Blinded, Sham-Controlled Study.
Low Intensity Shockwaves Therapy for the Treatment of Erectile Dysfunction. 12- Month Follow-Up
Sponsors
Source
University of Miami
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
Yes
Is Unapproved Device
No
Is Us Export
No
Brief Summary
Erectile Dysfunction (ED) is a condition with an inability to develop or maintain an erection
of the penis upon sexual stimulation. It occurs in association with aging, chronic illnesses
and various modifiable risk factors. Amongst the modifiable risk factors, ED shares the most
common risk factors with Coronary Artery Disease (CAD) which are smoking, hypertension and
hyperlipidemia1. Even though it is not a part of normal aging, it is seen in 52% men in the
age group 40 to 70 years, with a higher rate in the men more than 70 years2
Detailed Description
Erectile Dysfunction (ED) is a condition with an inability to develop or maintain an erection
of the penis upon sexual stimulation. It occurs in association with aging, chronic illnesses
and various modifiable risk factors. Amongst the modifiable risk factors, ED shares the most
common risk factors with Coronary Artery Disease (CAD) which are smoking, hypertension and
hyperlipidemia1. Even though it is not a part of normal aging, it is seen in 52% men in the
age group 40 to 70 years, with a higher rate in the men more than 70 years.
MoreNova is a Linear Shockwave (LISW) device, which incorporates a shockwave transducer
operable to deliver shockwaves to a treatment region confined to a narrow rectangle.
Shockwaves generation follows the electromagnetic principle.
Linear Shockwaves (LISW), as a treatment for ED has been in evaluation in contemporary
medicine (see section 1.4). It has been in use for the last five years.
The present study will utilize a device called "MoreNova", in which shockwaves are focused
onto line segments for improved organ coverage. Shockwaves produced by "MoreNova" 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 of LISW in the treatment of ED.
Overall Status
Recruiting
Start Date
2019-05-01
Completion Date
2021-05-01
Primary Completion Date
2020-05-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
International Index of Erectile Function ( IIEF-EF) |
13 months |
Secondary Outcome
Measure |
Time Frame |
|
Sexual Encounter Profile (SEP) |
13 months |
|
Doppler Ultrasound - to measure blood flow |
13 months |
Enrollment
120
Condition
Intervention
Intervention Type
Device
Intervention Name
Description
This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic ED patients. The patients are randomized in a 2:1 ratio of active to sham treatment groups. Patients randomized to the treatment group will be instructed to stop any use of PDE5i for 4 weeks prior to first treatment session and refrain from using any other ED therapy option during the study. They will be instructed to undergo a PDE5i washout period of 4 weeks prior to treatment. After the washout period and before the first treatment session, patients will answer the IIEF-EF, SEP and EHS questionnaires for baseline evaluation. Penile Doppler ultrasound will be performed by the time of enrollment, at 1,3, 6, 9 and 12 months and after treatment.
Arm Group Label
720 shockwave therapy
None shockwave therapy
Eligibility
Criteria
Inclusion Criteria:
- • The patient must be able willing and able to provide informed consent.
- The patient is a male between >30 and <70 years of age.
- The patient has ED based of IIEF scores.
- The patient has been in a stable relationship for over 3 months prior to
enrollment.
- A minimum of 2 sexual attempts per month for at least one month prior to
enrollment - as documented by International Index of Erectile Dysfunction (IIEF)
- The patient is suffering from erectile dysfunction lasting for over 6 months and
not more than 5 years as per history provided by patient.
- IIEF-EF score between 16 and 25.
- Testosterone level 300-1000 ng/dL within 1 month prior to enrollment. A1C level ≤
7% within 1 month prior to enrollment
Exclusion Criteria:
- 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.
- Evidence of venous leak.
- 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 Parkinson's disease which affects erectile
function at the discretion of the investigator.
- Psychiatric diagnosis or medications such as antidepressants, anxiolytic,
antipsychotic that 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.
- A1C level > 7% within 1 month prior to enrollment or history of Insulin dependent
diabetes.
- The patient is taking blood thinners and has an international normalized ratio >3.
- Received shockwave treatment at least 6 months before enrollment.
Gender
Male
Gender Based
Yes
Minimum Age
30 Years
Maximum Age
70 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
Ranjith Ramasamy, MD |
Principal Investigator |
University of Miami |
Overall Contact
Location
Facility |
Status |
Contact |
|
University of Miami Miami Florida 33136 United States |
Recruiting |
Location Countries
Country
United States
Verification Date
2019-06-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
University of Miami
Investigator Full Name
Ranjith Ramasamy, MD
Investigator Title
Director of Male Fertility/ Andrology department
Has Expanded Access
No
Condition Browse
Secondary Id
20181840
Number Of Arms
2
Arm Group
Arm Group Label
720 shockwave therapy
Arm Group Type
Active Comparator
Description
5 Daily sessions of shockwave therapy within a week.( Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shock of treatment energy will be applied in every session to each region ( left and right corpora cavernosa and crura)
Arm Group Label
None shockwave therapy
Arm Group Type
Sham Comparator
Description
5 Daily sessions of shockwave therapy within a week.( Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shock of treatment energy will be applied in every session to each region ( left and right corpora cavernosa and crura. The device probe, will be covered with a cap that will stopped the transmission of shockwaves.
Firstreceived Results Date
N/A
Overall Contact Backup
Reference
Citation
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. Epub 2005 Aug 24.
PMID
16174548
Citation
Melman A, Gingell JC. The epidemiology and pathophysiology of erectile dysfunction. J Urol. 1999 Jan;161(1):5-11. Review.
PMID
10037356
Citation
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. Epub 2010 Feb 4.
PMID
20134096
Citation
Haupt G, Haupt A, Ekkernkamp A, Gerety B, Chvapil M. Influence of shock waves on fracture healing. Urology. 1992 Jun;39(6):529-32.
PMID
1615601
Citation
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
Citation
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
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.
PMID
20451317
Citation
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
Citation
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.
PMID
9187685
Citation
Mulhall JP, Goldstein I, Bushmakin AG, Cappelleri JC, Hvidsten K. Validation of the erection hardness score. J Sex Med. 2007 Nov;4(6):1626-34. Epub 2007 Sep 21.
PMID
17888069
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
September 10, 2018
Study First Submitted Qc
September 12, 2018
Study First Posted
September 13, 2018
Last Update Submitted
June 26, 2019
Last Update Submitted Qc
June 26, 2019
Last Update Posted
July 1, 2019
ClinicalTrials.gov processed this data on December 10, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.