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Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Low-intensity extracorporeal shock wave therapy (Li-ESWT)
Sponsored by
Boston Medical Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men over 18 years of age
  • Presence of ED for more than 3 months in over 50% of sexual intercourses.
  • Baseline ED domain score under 26 on the IIEF-15 EF domain.
  • Patient agrees to participate in the trial by providing signed informed consent.

Exclusion Criteria:

  • EHS score of 4.
  • Patients with an INR over 3.
  • Patients with sickle-cell anemia.
  • Patients with clinical suspicion of hypogonadism (AMS over 36).
  • Endocrine diseases that present with ED, such as acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgen deficiency.
  • Active vesicular, prostrate or colon cancer.
  • Radical prostatectomy or other radical pelvic surgery.
  • History of pelvic radiation therapy.
  • Patients with ED of psychological origin.
  • Spinal cord injury or other neurological diseases associated with ED.
  • Anatomical penile dysfunction, penile implant.
  • Patients with active infections or lesions on the penis or pubic area.
  • Patients with ED secondary to drug therapy (antiandrogen therapy, alpha blockers for BPH, use of corticosteroids, medication for Parkinson's disease, antipsychotics).
  • Abuse of psychoactive substances.

Sites / Locations

  • Boston Medical Group ColombiaRecruiting
  • Boston Medical Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Protocol 1

Protocol 2

Protocol 3

Arm Description

Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six sessions, one per week, with 3000 pulses at 0.20 mj/mm2, at a frequency of 4Hz. At all of the shockwave sessions, 2000 pulses will be distributed to the body of the penis and 1000 pulses will be applied to the base.

Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six initial sessions, one per week, with 3000 pulses at 0.20 mj/mm2, at a frequency of 4Hz for six weeks, followed by monthly maintenance sessions (every 4 weeks) for five months. At all of the shockwave sessions, 2000 pulses will be distributed to the body of the penis and 1000 pulses will be applied to the base.

Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six monthly sessions in which 3000 pulses will be applied at 0.20 mj/mm2, at a frequency of 4Hz, with 2000 pulses distributed to the body of the penis and 1000 pulses applied to the base

Outcomes

Primary Outcome Measures

IIEF-EF score 6 months after completing the treatment
This is a highly sensitive and specific scale for detecting changes in erectile function in response to treatment. The degree of dysfunction is scored on a range of 0 to 30 points on the Erectile Functioning domain (questions 1, 2, 3, 4, 5, 15). The categories are: severe between 0 and 10, moderate between 11 and 16, mild-to-moderate between 17 and 21, mild between 22 and 25, and no ED between 26 and 30.

Secondary Outcome Measures

Erection Hardness Score
The EHS has a single Likert scale: 0 = Penis does not increase in size; 1= the penis increases in size but is not hard; 2 = the penis is hard but not hard enough for penetration; 3 = the penis is hard enough for penetration but not completely hard; 4 = the penis is completely hard and fully rigid
Clinical improvement
For patients with moderate ED, a 5-point increase in the IIEF-EF score is considered improvement. For patients with mild ED a 2-point increase on this scale is considered improvement. And for those with severe ED a 7-point change is considered improvement.
Number of satisfactory relations
According to the patient's journal records. For the purpose of this study, satisfactory relations are defined as the increase in rigidity and duration of the erection as evaluated by the patient and his partner. For patients who were not able to penetrate before treatment, satisfactory relations will include not only an increase in rigidity and duration of the erection but also the ability to penetrate.

Full Information

First Posted
October 9, 2017
Last Updated
December 19, 2019
Sponsor
Boston Medical Group
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1. Study Identification

Unique Protocol Identification Number
NCT03308409
Brief Title
Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction
Official Title
Clinical Randomized Multicentric Trial to Evaluate the Comparative Effectiveness and Safety of Three Protocols Using Low-intensity Shock Waves for the Treatment of Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The patients with primary erectile dysfunction (IIEF-EF <26 points), will be randomly assigned to three shockwave treatment protocols: Protocol 1 six sessions, one per week; Protocol 2, six initial sessions, one per week, followed by monthly maintenance sessions (every 4 weeks) for five months; Protocol 3, six monthly sessions. The EHS and IIEF-EF scores will be compared as well as the possible adverse events from the therapy upon beginning and completing the treatment and at the 3-month and 6-month follow-ups. Self-esteem and quality of life will also be evaluated using the SEAR scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
279 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Protocol 1
Arm Type
Active Comparator
Arm Description
Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six sessions, one per week, with 3000 pulses at 0.20 mj/mm2, at a frequency of 4Hz. At all of the shockwave sessions, 2000 pulses will be distributed to the body of the penis and 1000 pulses will be applied to the base.
Arm Title
Protocol 2
Arm Type
Experimental
Arm Description
Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six initial sessions, one per week, with 3000 pulses at 0.20 mj/mm2, at a frequency of 4Hz for six weeks, followed by monthly maintenance sessions (every 4 weeks) for five months. At all of the shockwave sessions, 2000 pulses will be distributed to the body of the penis and 1000 pulses will be applied to the base.
Arm Title
Protocol 3
Arm Type
Experimental
Arm Description
Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six monthly sessions in which 3000 pulses will be applied at 0.20 mj/mm2, at a frequency of 4Hz, with 2000 pulses distributed to the body of the penis and 1000 pulses applied to the base
Intervention Type
Other
Intervention Name(s)
Low-intensity extracorporeal shock wave therapy (Li-ESWT)
Intervention Description
Low-intensity shock waves are acoustic wavelengths which are transmitted continuously at a frequency between 16 and 20 megahertz for under 10 microseconds. They generate a pressure pulse and transport energy as they propagate through a medium. Three different methods can be used to generate this type of wave: electro-hydraulics, electro-magnetics and piezoelectricity. Regardless of the method, when the shock waves are applied to an organ they interact with the deep tissue. This causes stress and small mechanical traumas, activating the release of angiogenic factors which induce new vascularization of the affected tissue, thereby improving blood flow.
Primary Outcome Measure Information:
Title
IIEF-EF score 6 months after completing the treatment
Description
This is a highly sensitive and specific scale for detecting changes in erectile function in response to treatment. The degree of dysfunction is scored on a range of 0 to 30 points on the Erectile Functioning domain (questions 1, 2, 3, 4, 5, 15). The categories are: severe between 0 and 10, moderate between 11 and 16, mild-to-moderate between 17 and 21, mild between 22 and 25, and no ED between 26 and 30.
Time Frame
6 month follow-ups
Secondary Outcome Measure Information:
Title
Erection Hardness Score
Description
The EHS has a single Likert scale: 0 = Penis does not increase in size; 1= the penis increases in size but is not hard; 2 = the penis is hard but not hard enough for penetration; 3 = the penis is hard enough for penetration but not completely hard; 4 = the penis is completely hard and fully rigid
Time Frame
3-month and 6-month follow-ups
Title
Clinical improvement
Description
For patients with moderate ED, a 5-point increase in the IIEF-EF score is considered improvement. For patients with mild ED a 2-point increase on this scale is considered improvement. And for those with severe ED a 7-point change is considered improvement.
Time Frame
6-month follow-ups
Title
Number of satisfactory relations
Description
According to the patient's journal records. For the purpose of this study, satisfactory relations are defined as the increase in rigidity and duration of the erection as evaluated by the patient and his partner. For patients who were not able to penetrate before treatment, satisfactory relations will include not only an increase in rigidity and duration of the erection but also the ability to penetrate.
Time Frame
3-month and 6-month follow-ups

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men over 18 years of age Presence of ED for more than 3 months in over 50% of sexual intercourses. Baseline ED domain score under 26 on the IIEF-15 EF domain. Patient agrees to participate in the trial by providing signed informed consent. Exclusion Criteria: EHS score of 4. Patients with an INR over 3. Patients with sickle-cell anemia. Patients with clinical suspicion of hypogonadism (AMS over 36). Endocrine diseases that present with ED, such as acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgen deficiency. Active vesicular, prostrate or colon cancer. Radical prostatectomy or other radical pelvic surgery. History of pelvic radiation therapy. Patients with ED of psychological origin. Spinal cord injury or other neurological diseases associated with ED. Anatomical penile dysfunction, penile implant. Patients with active infections or lesions on the penis or pubic area. Patients with ED secondary to drug therapy (antiandrogen therapy, alpha blockers for BPH, use of corticosteroids, medication for Parkinson's disease, antipsychotics). Abuse of psychoactive substances.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Saffon, Doctor
Phone
3208899777
Ext
104
Email
jpsaffon@bostonmedical.com.co
Facility Information:
Facility Name
Boston Medical Group Colombia
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
11022
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Sandoval
Phone
57 3208899777
Email
csandoval@bostonmedical.com.co
Facility Name
Boston Medical Group
City
Mexico City
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Barba
Email
jbarba@bostonmedical.com.mx

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction

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