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TerminatedNCT03670628Updated Jul 10, 2023Results posted

Low Intensity Shockwaves Therapy for the Treatment of Erectile Dysfunction. 12- Month Follow-Up

An interventional study of Shockwave therapy and Sham shockwave therapy in Erectile Dysfunction, sponsored by University of Miami. Terminated at 1 site in United States. Open to male participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-10.

Sponsored by University of Miami · Not applicable, Interventional, and Treatment

Why this study was terminated
Due to COVID-19 Pandemic
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
Male
01

Study summary

The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.

02

Conditions studied

  • Erectile Dysfunction

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03

In context

Erectile Dysfunction

698 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.

This study's enrollment of 23 is below the median of 72 across 552 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

University of Miami is the lead sponsor of 838 studies on the registry; 164 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 96 (84%) have results posted.

Browse University of Miami studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The patient must be able willing and able to provide informed consent.
  • The patient is a male between 30 and 70 years of age (inclusive).
  • The patient has erectile dysfunction (ED) based of IIEF scores.
  • The patient has been in a stable relationship for over 3 months prior to enrollment.
  • A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by International Index of Erectile Dysfunction (IIEF)
  • The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient.
  • IIEF-EF score between 16 and 25.
  • Testosterone level 300-1000 ng/dL within 1 month prior to enrollment. A1C level ≤ 7% within 1 month prior to enrollment

Exclusion criteria

Exclusion Criteria:

  • The patient is currently or has participated in another study within the past three months that may interfere with the results or conclusions of this study.
  • The patient is under judicial protection (prison or custody).
  • The patient is an adult under guardianship.
  • The patient refuses to sign the consent.
  • History of radical prostatectomy or extensive pelvic surgery.
  • Evidence of venous leak.
  • Past radiation therapy of the pelvic region within 12 months prior to enrollment.
  • Recovering from any cancer within 12 months prior to enrollment.
  • Neurological disease such as Alzheimers or Parkinson's disease which affects erectile function at the discretion of the investigator.
  • Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator.
  • Anatomical malformation of the penis, including Peyronie's disease.
  • Testosterone level \<300 or >1000 ng/dL within 1 month prior to enrollment.
  • A1C level > 7% within 1 month prior to enrollment or history of Insulin dependent diabetes.
  • The patient is taking blood thinners and has an international normalized ratio >3.
  • Received shockwave treatment at least 6 months before enrollment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • Active comparator
    720 shockwave therapy Group

    Participants in this group will receive a total of 5 daily sessions of shockwave therapy within a week. Each therapy session will consist of 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)

    Device: Shockwave therapy

  • Sham comparator
    Sham shockwave therapy

    Participants in this group will receive a total of 5 daily sessions of sham shockwave therapy within a week. Sham therapy will be applied to the penis and to the left and right crus (shaft near the base).

    Other: Sham shockwave therapy

Interventions

  • DeviceShockwave therapy

    Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)

  • OtherSham shockwave therapy

    Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base)

06

What researchers measure

Primary outcomes

  1. International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.

    The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

Secondary outcomes

  1. Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire

    The SEP consists of two questions: 1) Over the past 4 weeks, were you able to insert your penis into your partner's vagina? and 2) Over the past 4 weeks, did your erection last long enough for you to have successful intercourse? Reported will be the number of participants responding yes to the 2 questions.

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

  2. Erection Hardness Score (EHS)

    EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

07

Results

Posted Jul 10, 2023

Participant flow

Unable to complete target enrollment due to COVID-19 pandemic restrictions.

Baseline Visit
Participant flow — Baseline Visit
Milestone720 Shockwave Therapy GroupSham Shockwave Therapy
Started1310
Completed1310
Not completed00
Weekly Therapy Sessions
Participant flow — Weekly Therapy Sessions
Milestone720 Shockwave Therapy GroupSham Shockwave Therapy
Started1310
Completed57
Not completed83
Withdrew: Enrollment was halted; participants were unable to attend study visits due to covid-19 restrictions.83
Month 1 Visit
Participant flow — Month 1 Visit
Milestone720 Shockwave Therapy GroupSham Shockwave Therapy
Started57
Completed57
Not completed00
Waiting Period
Participant flow — Waiting Period
Milestone720 Shockwave Therapy GroupSham Shockwave Therapy
Started57
Completed11
Not completed46
Withdrew: Enrollment was halted; participants were unable to attend study visits due to covid-19 restrictions.46
Month 3 Visit
Participant flow — Month 3 Visit
Milestone720 Shockwave Therapy GroupSham Shockwave Therapy
Started11
Completed11
Not completed00

Outcome measures

PrimaryInternational Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.

The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.

Time frame:
Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Reported as:
Mean · score on a scale
International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.
score on a scale720 Shockwave Therapy GroupSham Shockwave Therapy
Baseline18.8 ± 2.719.1 ± 3.6
Month 118.4 ± 7.117 ± 4.5
Month 318 ± NA26 ± NA
SecondaryNumber of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire

The SEP consists of two questions: 1) Over the past 4 weeks, were you able to insert your penis into your partner's vagina? and 2) Over the past 4 weeks, did your erection last long enough for you to have successful intercourse? Reported will be the number of participants responding yes to the 2 questions.

Time frame:
Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Reported as:
Number · participants
Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire
participants720 Shockwave Therapy GroupSham Shockwave Therapy
Baseline72
Month 132
Month 310
SecondaryErection Hardness Score (EHS)

EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness

Time frame:
Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Reported as:
Mean · score on a scale
Erection Hardness Score (EHS)
score on a scale720 Shockwave Therapy GroupSham Shockwave Therapy
Baseline2.9 ± 0.32.8 ± 0.6
Month 13.4 ± 0.53.1 ± 0.4
Month 33 ± NA4 ± NA

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
720 Shockwave Therapy Group0/13 (0%)0/13 (0%)0/13 (0%)
Sham Shockwave Therapy0/10 (0%)0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)720 Shockwave Therapy GroupSham Shockwave TherapyTotal
Mean52.4 ± 10.551.2 ± 8.951.7 ± 9.4
Sex: Female, Male
Sex: Female, Male(Participants)720 Shockwave Therapy GroupSham Shockwave TherapyTotal
Female000
Male131023
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)720 Shockwave Therapy GroupSham Shockwave TherapyTotal
Count of participants——0
08

Study locations

1 site
  • University of Miami
    Miami, Florida 33136, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 2, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2019 to primary completion in Nov 2021, 30 months.

Results were first posted in Jul 2023, 1 year 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2018
First posted
Sep 13, 2018
StartActual
May 1, 2019
Primary completionActual
Nov 12, 2021
CompletionActual
Nov 12, 2021
Results first posted
Jul 10, 2023
Last update
Jul 10, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03670628
Lead sponsor
University of Miami
Responsible party
Ranjith Ramasamy, MD (Director of Male Fertility/ Andrology department, University of Miami) — Principal investigator
First posted
Sep 13, 2018
Start date
May 1, 2019
Primary completion
Nov 12, 2021
Completion
Nov 12, 2021
Results posted
Jul 10, 2023
Last update
Jul 10, 2023

Study contacts

Ranjith Ramasamy, MD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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