LI-ESWT Versus Sham Therapy in Men With ED

NCT04721834 | Unknown

• 1 other identifier: KEC-ESWT-RCT
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hong Kong has an aging population. By the year of 2036, more than 30% of our population will be older than 65 years old1. Aging in male has been shown to correlate with the risk of erectile dysfunction(ED). The demand in ED treatment is expected to increase. Several ED treatment options are available, ranging from oral or intracavernosal drug treatments, to vacuum erection therapy or even penile prosthesis implantation. However, none of these treatment are curative nor rectify the pathophysiology of ED. Low-intensity extra-corporeal shockwave therapy(LI-ESWT) has been introduced since 2010 for treatment of ED. The first randomized-controlled trial by Vardi et al. had proved the efficacy of ESWT in improving the International Index of Erectile Function(IIEF) score3. The International Index of Erectile Function-Erectile Function domain score(IIEF-EF) was significantly greater in the treatment group compared with the sham therapy group. The efficacy of LI-ESWT was also confirmed in meta-analyses. Nonetheless, the available studies were criticized for the variations in shockwave generators, energy parameters and treatment protocol. Most studies used focused electrohydraulic machines, did not include NPT as part of the outcomes assessment, and only reported the short-term outcomes. Currently LI-ESWT machine was used in few Hong Kong public hospitals for the treatment of erectile dysfunction. In KEC, few pilot cases have been done using the linear LI-ESWT machine. No adverse events were seen. Local published data is lacking. Yee et al. has published a double-blinded randomized placebo-controlled trial on LI-ESWT in 20144. Using an electrohydraulic machine with a focused shockwave source, they concluded no significant differences in IIEF-EF and Erectile Hardness Score(EHS) between treatment and sham therapy after 13 weeks of treatment. In subgroup analysis significant improvement was noted in men with severe baseline erectile dysfunction (LI-ESWT IIEF-EF improvement: 10.1 ± 4.1 vs sham therapy IIEF-ED domain improvement: 3.2 ± 3.3; P = 0.003). There were several limitations in this study. These include the small number of participants included in the subgroup analysis (ranges from 18 to 21 men in each subgroups), the lack of physical measurement of erectile function. The percentage of patients with 5 points or more IIEF-EF improvement and the Erection Hardness Score(EHS) were also not reported. They have also used an old design with focused energy source, instead of the linear energy source. In light of the limitations of the previous international and local studies, the investigators plan to investigate the efficacy of a linear electromagnetic LI-ESWT machine in men with moderate and severe ED. In addition, the intermediate-term outcomes would be studied, in terms of patients-reported erection scores and nocturnal tumescence and rigidity measurement.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) score

  Validated questionnaire in assessing the erectile function over the past 4 weeks Minimum value - 1 Maximum values - 30 Higher scores represent a better outcome

  One month after treatment, compared with pre-op level

Secondary Outcomes (7)

• Erection Hardness Score (EHS)

  At week 4, 26 and 52 after treatment

• Percentage of patients with 5-points International Index of Erectile Function - Erectile Function Domain improvement

  At week 4, 26 and 52 after treatment

• Percentage of patients with Erection Hardness Score improved to 3 or above

  At week 4, 26 and 52 after treatment

• Frequency of nocturnal erections

  At week 4 and 52 after treatment

• Duration of nocturnal erections

  At week 4 and 52 after treatment

Study Arms (2)

Low-intensity ESWT

ACTIVE COMPARATOR

Patient would be positioned in a supine position. Shockwaves would be delivered to the stretched penis at proximal, mid and distal penile shaft and bilateral crura of penis. (Energy: 0.1-0.25 mJ/mm2; 3000pulses per session; Frequency 3Hz) Treatment consists of 6 sessions over 5 weeks in total. It would be a twice-weekly treatment with one-week interval of resting period. Patient would be discharged home after each treatment session.

Device: Low-intensity Extracorporeal Shockwave Therapy

Sham ESWT

SHAM COMPARATOR

Sham therapy would be given with a modified probe which no shockwave would be emitted. A working noise would still be generated which mimicked active treatment.

Device: Sham Therapy

Interventions

Low-intensity Extracorporeal Shockwave Therapy DEVICE

Low intensity shockwave energy would be delivered to stimulate angiogenesis in corporal tissue. Therapy would be delivered through a linear probe in 6 sessions. It would be conducted as a day procedure.

Low-intensity ESWT

Sham Therapy DEVICE

Same device as the active treatment arm would be used, with the addition of sham probe which block all shockwaves.

Sham ESWT

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Only male subjects are eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 50 years old
• ED \> 6 months
• Stable heterosexual relationship \> 6 months
• Sexual Health Inventory for Men (SHIM) score \<= 16
• Suboptimal response after first line phosphodiesterase type 5 inhibitor treatment

You may not qualify if:

• Penile anatomical abnormality
• History of pelvic radiotherapy
• History of radical prostatectomy
• History of penile implantations
• Neurological diseases
• Hypogonadism or on anti-androgen therapy
• Unstable psychiatric conditions or under active psychiatric treatment

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead

Related Publications (5)

• Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.

  PMID: 8254833 BACKGROUND

• 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 BACKGROUND

• Yee CH, Chan ES, Hou SS, Ng CF. Extracorporeal shockwave therapy in the treatment of erectile dysfunction: a prospective, randomized, double-blinded, placebo controlled study. Int J Urol. 2014 Oct;21(10):1041-5. doi: 10.1111/iju.12506. Epub 2014 Jun 17.

  PMID: 24942563 BACKGROUND

• Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13.

  PMID: 27986492 BACKGROUND

• 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 BACKGROUND

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 Officials

• Kwun Chung CHENG, FRCS

  Hospital Authority, Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwun Chung CHENG, FRCS

CONTACT

39494000; ckc640@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: During treatment for the placebo arm, a sham probe will be used which will produce a noise mimicking active treatment. Subjects would be blinded from randomization, treatment, until the end of follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: January 25, 2021
• Study Start: January 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share