The Effect of Combination Therapy Using Li-ESWT and PDE-5 Inhibitor in Patients With Erectile Dysfunction

NCT ID: NCT05043896

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2020-06-30

Brief Summary

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to compare the effect of combination of li-eswt and pde-5 inhibitor to pde-5 alone in erectile dysfunction patients

Detailed Description

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Comparing the effect of Combination therapy (Li-ESWT combined with PDE5-inhibitor) vs SIngle therapy (PDE5-inhibitor) in mild to moderate Erectile Dysfunction patients.

Parameters used for comparation are EHS score, IIEF-5 score, VEGF level and PSV

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Combination therapy

Li-ESWT + tadalafil

Group Type EXPERIMENTAL

Li-ESWT

Intervention Type PROCEDURE

Li-ESWT twice weekly for 4 weeks

Tadalafil 2.5Mg Tab

Intervention Type DRUG

tadalafil 2.5mg once daily

Single Therapy

tadalafil only

Group Type SHAM_COMPARATOR

Tadalafil 2.5Mg Tab

Intervention Type DRUG

tadalafil 2.5mg once daily

Interventions

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Li-ESWT

Li-ESWT twice weekly for 4 weeks

Intervention Type PROCEDURE

Tadalafil 2.5Mg Tab

tadalafil 2.5mg once daily

Intervention Type DRUG

Other Intervention Names

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Shockwave Therapy Standard First Line Therapy

Eligibility Criteria

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Inclusion Criteria

* Mild to Moderate Erectile dysfunction
* Married
* Sexually active
* Consenting to participate in the trial

Exclusion Criteria

* Psychological problems
* Spinal injury
* History of malignancy
* Penile anatomy abnormalities
* Allergic and Contraindications to tadalafil
* On anti-mitotic drugs
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dr. Soetomo General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Andrian, dr., Sp.And

Resident of Andrology Department, Principal Investigator, Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tjahjo Tanojo, dr

Role: PRINCIPAL_INVESTIGATOR

Dr. Soetomo General Hospital, Andrology Clinic

Locations

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dr. Soetomo General Hospital

Surabaya, East Java, Indonesia

Site Status

Countries

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Indonesia

Provided Documents

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Document Type: Study Protocol: Study Protocol Chart

View Document

Document Type: Study Protocol: Ethical Clearance

View Document

Document Type: Study Protocol and Statistical Analysis Plan: Study Protocols and Statistical Analysis Plan

View Document

Document Type: Statistical Analysis Plan: Statistics Results

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1690/KEPK/XII/2019

Identifier Type: -

Identifier Source: org_study_id

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