NCT03741439

Brief Summary

Even though, the efficacy of Low-Intensity Shockwave Therapy (LIST) to treat Erectile Dysfunction (ED) has been documented by numerous trials; it is still not recommended by clinical guidelines. Different types of: shockwave generators, treatment protocols and ED severities of patients included in the studies, explain the lack of recommendations for a standard treatment. Ideally, each shockwave generator should have its own efficacy data from randomized controlled trials, using standardized protocols, and in defined populations. Objective: to test the efficacy of a electromagnetic shockwave generator (Dornier Aries) in treating patients with mild and moderate ED in a randomized controlled trial. Patients and methods: 38 patients with mild/moderate ED (IIEF-5= 11-21), are being prospectively randomized (1:1) to receive 6 sessions of LIST or sham (same: number of sessions, time and sound, with out transmitting energy). The patients and who analyzed the data are blind to randomization. The following parameters were analyzed: IIEF-5, IIEF-15, Sexual Encounter Profile (SEP) 2 and 3, Global Assessment Question (GAQ) 1 and Erection Hardness Score (EHS) at: baseline (T0), at the end of the 6 sessions (T1); at 6 (T2) and 12 weeks (T3). During all the study patients were instructed to receive no other treatment for ED. After ending T3 we expect to treat placebo patients to see impact of changing arm study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2019

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

10 months

First QC Date

November 11, 2018

Last Update Submit

November 11, 2018

Conditions

Erectile DysfunctionEndothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Changes in IIEF-5

    We expect a change of 3.5 points in the IIEF-5 score

    12 weeks

Study Arms (2)

Treatment arm

EXPERIMENTAL

Receives real treatment according to manufactures instructions. 6 sessions of low intensity shockwave treatment with an electromagnetic emitter.

Device: Treatment

Sham Arm

SHAM COMPARATOR

Receives sham treatment with same applicator, same sound, same time and number of shocks. But no real energy is delivered.

Device: Sham

Interventions

TreatmentDEVICE

Low intensity shockwave treatment in patients with mild/moderate ED using a electromagnetic emitter

Treatment arm
ShamDEVICE

Sham treatment

Sham Arm

Eligibility Criteria

Age40 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly men because is for erectile dysfunction.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild/moderate erectile dysfunction
  • Good response to any phospodiesterase inhibitor

You may not qualify if:

  • No history of erectile dysfunction
  • No decompensated diabetes
  • No untreated hypogonadism
  • No severe erectile dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad de Andrologia - Red Salud UC/Christus

Santiago, Santiago Metropolitan, RM, Chile

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Marcelo Marconi, MD

    Asistant Professor Urology Department Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo Marconi, MD

CONTACT

+56979685115mmarconi@andro.cl

Marcelo Marconi, MD

CONTACT

+56979685115

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Patients and who analyzes the data are blind to randomization.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2018

First Posted

November 14, 2018

Study Start

January 17, 2018

Primary Completion

November 2, 2018

Study Completion

January 2, 2019

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

CL(1)