Treatment of Erectile Dysfunction With Low-intensity Extracorporeal Shockwave Therapy

NCT03986359 | Unknown

• 1 other identifier: T-NTUH-57401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction Following Radiation Therapy

Keywords

low-intensity extracorporeal shockwave therapy; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• IIEF-5 score

  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

  the 4th week and the 8th week

Secondary Outcomes (3)

• Penile Doppler Ultrasound (PDU)

  the 4th week and the 8th week

• EHS（Erection Hardness Score）

  the 4th week and the 8th week

• QoL: questionnaire

  the 4th week and the 8th week

Study Arms (2)

1

EXPERIMENTAL

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

2

SHAM COMPARATOR

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

Interventions

low energy extracorporeal shockwave therapy DEVICE

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

1; 2

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Patient ever received low intensity shockwave or who does not have sex intercourse in recent six months.

Sponsors & Collaborators

• National Taiwan University: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 30664671 RESULT

• 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.

  PMID: 30956690 RESULT

• 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.

  PMID: 31027441 RESULT

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: While subjects receive Sham therapy, the machine turning on but the energy is zero.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: September 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: April 30, 2020
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

TW (1)