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Treatment of Erectile Dysfunction With Low-intensity Extracorporeal Shockwave Therapy

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ClinicalTrials.gov Identifier: NCT03986359
Recruitment Status : Enrolling by invitation
First Posted : June 14, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Fu-Shun Hsu, National Taiwan University

Brief Summary:
This study is a prospective, randomized, single-blinded, cross-over trial to investigate the efficacy of low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction (ED). We will enroll 60 subjects (International Index of Erectile Function Questionnaires, 5 ≦ IIEF-5 ≦ 21). 30 subjects receive ESWT (LM-IASO, Litemed Co., Taiwan) for 6 courses in 3 weeks (0.05mJ/mm2, 3000 pulses) and 30 subjects receive Sham therapy for 3 weeks (the machine turning on but the energy is zero). After 3 weeks, the two groups are cross over. The primary outcome is the 4th week change from baseline for IIEF-5 score. Secondary outcomes are the 8th week change from baseline for IIEF-5 score, EHS, QoL; AEs. The between-group relationships of baseline and 4-week data were evaluated by using the Student's t-test or Mann-Whitney U-test where appropriate. Multiple linear regression was carried out to test the variables associated with treatment outcome. P-values < 0.05 were considered statistically significant.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Following Radiation Therapy Device: low energy extracorporeal shockwave therapy Not Applicable

Detailed Description:

Low-intensity extracorporeal shockwave therapy (LI-ESWT) was proved to be useful in various medical conditions; for example, neovascularization in myocardial ischemia, nonhealing wounds, ED and chronic pelvic pain syndrome.

The use of LI-ESWT has been increasingly proposed as a treatment for ED over the last decade. Overall, most of these studies reported encouraging results, regardless of variation in LI-ESWT set-up parameters or treatment protocols. As a whole these studies suggest that LI-ESWT could significantly improve the IIEF-5 and Erection Hardness Score of mild ED patients. However, no randomized control trial with cross-over designed studies so far.

This is a prospective, randomized, single-blind, cross-over clinical study. This study will be performed in outpatient setting of NTUH. Written informed consent will be given by all participants before entering the study. The subjects are treated at the therapy room of the department of urology, NTUH. All subjects would not pay any cost for this treatment/study. This study was approved by the institutional review board at National Taiwan University Hospital (NTUH, No. T-NTUH-57401).

Inclusion criteria: were patient age 20 ~ 70 year-old man, suffering from ED for over 6 months, and 5 ≦ IIEF-5 ≦ 21. The written informed consent forms from all subjects who met the inclusion criteria were obtained.

Exclusion criteria: Patients with penile implant, prior radical prostatectomy, rectal surgery, radiation therapy to the pelvic area, spinal cord injury, prostate cancer, bladder cancer, interstitial cystitis, or major depression were excluded. Patient ever received low intensity shockwave or who does not have sex intercourse in recent six months will be excluded.

Measurement of outcomes

Primary outcome: the 4th week and the 8th week change from baseline for IIEF-5 score change from baseline for IIEF-5 score.

Secondary outcomes: Penile Doppler Ultrasound (PDU) at 4th and 8th week , EHS, QoL; AEs

Methodology All patients diagnosed of erectile dysfunction will receive blood sampling of serum testosterone and lipid profile at the beginning of the study. All patients were treated at out-patient clinic. 30 subjects receive LI-ESWT (LM-IASO, Litemed Co., Taiwan) for 6 courses in 3 weeks (0.05mJ/mm2, 3000 pulses) and 30 subjects receive Sham therapy for 3 weeks (the machine turning on but the energy is zero). LI-ESWT is delivered by a probe that was attached to a electrohydraulic unit with a wide-focused shockwave source. The penis is manually stretched, and shockwaves are delivered to the whole penis shaft and penis base. The duration of each ESWT session is about 30 minutes, and comprised 3000 pulses (0.05mJ/mm2), and a frequency of 100/min.

Safety Considerations The peri- and post-treatment adverse events (AEs), including local pain, edema or hematoma were recorded and compared. With consideration of safety issue, any moderate/severe local pain or hematoma would be immediately reported and well inspected.

Follow-up The following parameters are assessed before treatment and weekly during the treatment: IIEF-5 score, EHS, QoL; AEs.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: We prospectively assessed the clinical outcome of LI-ESWT for the treatment of ED of organic origin. This study was approved by the institutional review board at National Taiwan University Hospital (NTUH, No. T-NTUH-57401).
Masking: Single (Participant)
Masking Description: While subjects receive Sham therapy, the machine turning on but the energy is zero.
Primary Purpose: Treatment
Official Title: Treatment of Erectile Dysfunction With Low-intensity Extracorporeal Shockwave Therapy: A Prospective, Randomized, Single-blind, Cross-over Study
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
30 subjects receive ESWT (LM-IASO, Litemed Co., Taiwan) for 6 courses in 3 weeks (0.05mJ/mm2, 3000 pulses). Thereafter, the two groups are cross over.
Device: low energy extracorporeal shockwave therapy
Low-intensity extracorporeal shockwave therapy (LI-ESWT) was proved to be useful in various medical conditions; for example, neovascularization in myocardial ischemia, nonhealing wounds, ED and chronic pelvic pain syndrome

Sham Comparator: 2
30 subjects receive Sham therapy for 3 weeks (the machine turning on but the energy is zero). Thereafter, the two groups are cross over.
Device: low energy extracorporeal shockwave therapy
Low-intensity extracorporeal shockwave therapy (LI-ESWT) was proved to be useful in various medical conditions; for example, neovascularization in myocardial ischemia, nonhealing wounds, ED and chronic pelvic pain syndrome




Primary Outcome Measures :
  1. IIEF-5 score [ Time Frame: the 4th week and the 8th week ]

    the 4th week and the 8th week change from baseline for IIEF-5 score change from baseline for IIEF-5 score.

    The IIEF-5 Questionnaire

    Over the past 6 months:

    1. How do you rate your confidence that you could get and keep an erection? (1-5)
    2. When you had erections with sexual stimulation, how often were your erections hard enough for penetration? (1-5)
    3. During sexual intercourse, how often were you able to maintain your erection after you had penetrated your partner? (1-5)
    4. During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse? (1-5)
    5. When you attempted sexual intercourse, how often was it satisfactory for you? (1-5) Total Score: 1-7: Severe ED 8-11: Moderate ED 12-16: Mild-moderate ED 17-21: Mild ED 22-25: No ED


Secondary Outcome Measures :
  1. Penile Doppler Ultrasound (PDU) [ Time Frame: the 4th week and the 8th week ]
    PDU at 4th and 8th week

  2. EHS(Erection Hardness Score) [ Time Frame: the 4th week and the 8th week ]

    EHS at 4th and 8th week EHS score

    How would you rate the hardness of your erection? select one of the following options:

    • 0 - Penis does not enlarge.
    • 1 - Penis is larger, but not hard.
    • 2 - Penis is hard, but not hard enough for penetration.
    • 3 - Penis is hard enough for penetration, but not completely hard.
    • 4 - Penis is completely hard and fully rigid.

  3. QoL: questionnaire [ Time Frame: the 4th week and the 8th week ]

    Quality-of-life questionnaire at 4th and 8th week

    Score 0 (the best) - 6 (the worst)




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients age 20 ~ 70 year-old man, suffering from ED for over 6 months.
  2. 5 ≦ IIEF-5 ≦ 21.

Exclusion Criteria:

  1. Patients with penile implant, prior radical prostatectomy, rectal surgery, radiation therapy to the pelvic area, spinal cord injury, prostate cancer, bladder cancer, interstitial cystitis, or major depression.
  2. Patient ever received low intensity shockwave or who does not have sex intercourse in recent six months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986359


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University

Publications of Results:
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Responsible Party: Fu-Shun Hsu, Principal Investigator, National Taiwan University
ClinicalTrials.gov Identifier: NCT03986359     History of Changes
Other Study ID Numbers: T-NTUH-57401
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fu-Shun Hsu, National Taiwan University:
low-intensity extracorporeal shockwave therapy
Erectile Dysfunction

Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders