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LI-ESWT Versus Sham Therapy in Men With ED

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ClinicalTrials.gov Identifier: NCT04721834
Recruitment Status : Not yet recruiting
First Posted : January 25, 2021
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
CHENG Kwun-Chung, Hospital Authority, Hong Kong

Study Description
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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.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: Low-intensity Extracorporeal Shockwave Therapy Device: Sham Therapy Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:

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.
Primary Purpose: Treatment
Official Title: Efficacy of Low-Intensity Extracorporeal Shockwave Therapy in Treatment of Erectile Dysfunction - A Randomized Controlled Trial With Sham Therapy
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Low-intensity ESWT
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
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.
Sham Comparator: Sham ESWT
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
Same device as the active treatment arm would be used, with the addition of sham probe which block all shockwaves.


Outcome Measures
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Primary Outcome Measures :
  1. Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) score [ Time Frame: One month after treatment, compared with pre-op level ]
    Validated questionnaire in assessing the erectile function over the past 4 weeks Minimum value - 1 Maximum values - 30 Higher scores represent a better outcome


Secondary Outcome Measures :
  1. Erection Hardness Score (EHS) [ Time Frame: At week 4, 26 and 52 after treatment ]
    Hardness score of penis. Minimum value is 1, maximum is 4. Higher score represents better erection hardness.

  2. Percentage of patients with 5-points International Index of Erectile Function - Erectile Function Domain improvement [ Time Frame: At week 4, 26 and 52 after treatment ]
    The percentage(%) of patients with 5 points or more International Index of Erectile Function - Erectile Function improvement compared with pre-study baseline level.

  3. Percentage of patients with Erection Hardness Score improved to 3 or above [ Time Frame: At week 4, 26 and 52 after treatment ]
    The percentage(%) of patients with Erection Hardness Score improved to 3 or above.

  4. Frequency of nocturnal erections [ Time Frame: At week 4 and 52 after treatment ]
    A non-invasive ambulatory diagnostic machine Rigiscan would be used to provide an objective measure of the frequency of nocturnal erections at night. (number of erections during sleeping)

  5. Duration of nocturnal erections [ Time Frame: At week 4 and 52 after treatment ]
    A non-invasive ambulatory diagnostic machine Rigiscan would be used to provide an objective measure of the duration of nocturnal erections.(Time in seconds)

  6. Change in nocturnal penile tumescence [ Time Frame: At week 4 and 52 after treatment ]
    A non-invasive ambulatory diagnostic machine Rigiscan would be used to provide an objective measure of the change in penile girth at penile base and penile tip during nocturnal erections.(in cm)

  7. Complications after the procedure [ Time Frame: Within 4 weeks after treatment ]
    Number of participants reported penile pain or urethral bleeding during treatment or within 4 weeks after the treatment.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only male subjects are eligible.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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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): NCT04721834


Contacts
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Contact: Kwun Chung CHENG, FRCS 39494000 ckc640@ha.org.hk

Sponsors and Collaborators
Hospital Authority, Hong Kong
Investigators
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Principal Investigator: Kwun Chung CHENG, FRCS Hospital Authority, Hong Kong
  Study Documents (Full-Text)

Documents provided by CHENG Kwun-Chung, Hospital Authority, Hong Kong:
Informed Consent Form  [PDF] August 3, 2020

More Information
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Publications:

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Responsible Party: CHENG Kwun-Chung, Associate Consultant, Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier: NCT04721834    
Other Study ID Numbers: KEC-ESWT-RCT
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders