RCTrial to Test Low Intensity Shockwave Treatment in Pati... | NCT03741439

Studies
RCTrial to Test Low Intensity Shockwave Treatment in Patients With Mild/Moderate Erectile Dysfunction

NCT03741439

Sponsor

IVI Santiago de Chile

Status

Unknown status

Last Update Posted

Nov 14, 2018Actual

Enrollment

38Estimated

Phase

Not Applicable

Conditions

Erectile Dysfunction
Endothelial Dysfunction

Interventions

Treatment
Sham

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2018Actual

Primary Completion Date

Nov 2, 2018Actual

Completion Date

Jan 2, 2019Estimated

First Submitted Date

Nov 11, 2018

First Submission Date that Met QC Criteria

Nov 11, 2018

First Posted Date

Nov 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2018

Last Update Posted Date

Nov 14, 2018Actual

Name	Class
Pontificia Universidad Catolica de Chile	OTHER
University of Chile	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

We are test the efficacy of a electromagnetic shockwave generator (Dornier Aries) in treating patients with mild and moderate ED in a randomized controlled trial.

After ending T3 we expect to treat placebo patients to see impact of changing arm study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Treatment	Device	Low intensity shockwave treatment in patients with mild/moderate ED using a electromagnetic emitter	Treatment arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in IIEF-5	We expect a change of 3.5 points in the IIEF-5 score	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mild/moderate erectile dysfunction
Good response to any phospodiesterase inhibitor

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Only men because is for erectile dysfunction.

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marcelo Marconi, MD	Contact	+56979685115		mmarconi@andro.cl
Marcelo Marconi, MD	Contact	+56979685115

Overall Officials

Name	Affiliation	Role
Marcelo Marconi, MD	Asistant Professor Urology Department Universidad Catolica de Chile	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unidad de Andrologia - Red Salud UC/Christus	Recruiting	Santiago	Santiago Metropolitan	RM	Chile

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

We are evaluating is we decide to share all the protocol. All the protocol will be published with the results.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided