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出境医 / 临床实验 / Treatment of Erectile Dysfunction With Low-intensity Extracorporeal Shockwave Therapy

Treatment of Erectile Dysfunction With Low-intensity Extracorporeal Shockwave Therapy

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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)



Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Locations
Layout table for location information
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University
Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date August 22, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019) 		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
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019) 		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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Penile Doppler Ultrasound (PDU) [ Time Frame: the 4th week and the 8th week ]
    PDU at 4th and 8th week
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • Penile Doppler Ultrasound (PDU) [ Time Frame: the 4th week and the 8th week ]
    PDU at 4th and 8th week
  • EHS（Erection Hardness Score） [ Time Frame: the 4th week and the 8th week ]
    EHS at 4th and 8th week
  • QoL: questionnaire [ Time Frame: the 4th week and the 8th week ]
    Quality-of-life questionnaire at 4th and 8th week
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Erectile Dysfunction With Low-intensity Extracorporeal Shockwave Therapy
Official Title  ICMJE Treatment of Erectile Dysfunction With Low-intensity Extracorporeal Shockwave Therapy: A Prospective, Randomized, Single-blind, Cross-over Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Erectile Dysfunction Following Radiation Therapy
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: low energy extracorporeal shockwave therapy
  • 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.
    Intervention: Device: low energy extracorporeal shockwave therapy
Publications *
  • Sokolakis I, Hatzichristodoulou G. Clinical studies on low intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic review and meta-analysis of randomised controlled trials. Int J Impot Res. 2019 May;31(3):177-194. doi: 10.1038/s41443-019-0117-z. Epub 2019 Jan 21.
  • Campbell JD, Trock BJ, Oppenheim AR, Anusionwu I, Gor RA, Burnett AL. Meta-analysis of randomized controlled trials that assess the efficacy of low-intensity shockwave therapy for the treatment of erectile dysfunction. Ther Adv Urol. 2019 Mar 29;11:1756287219838364. doi: 10.1177/1756287219838364. eCollection 2019 Jan-Dec.
  • Dong L, Chang D, Zhang X, Li J, Yang F, Tan K, Yang Y, Yong S, Yu X. Effect of Low-Intensity Extracorporeal Shock Wave on the Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis. Am J Mens Health. 2019 Mar-Apr;13(2):1557988319846749. doi: 10.1177/1557988319846749.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 13, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986359
Other Study ID Numbers  ICMJE T-NTUH-57401
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fu-Shun Hsu, National Taiwan University
Study Sponsor  ICMJE National Taiwan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Taiwan University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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