NCT05199727

Brief Summary

The objective of this study is to evaluate the effectiveness and safety of focused Li-ESWT on 25 participants complaining of ED compared to 25 participants complaining of ED on medical treatment on a prospective clinical trial for 12 weeks.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

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

September 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

December 20, 2021

Last Update Submit

January 6, 2022

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunctionShock waveClinical trial

Outcome Measures

Primary Outcomes (1)

  • Erectile function assessed by International Index of Erectile Function-5

    We will asessess erectile function using International Index of Erectile Function-5 (IIEF-5) where scores ≤6, severe; 8-16, moderate; 17-21, mild; and 22-25, none.

    3 months

Secondary Outcomes (1)

  • Erection hardness score

    3 months

Study Arms (2)

Shockwave group

EXPERIMENTAL

This group will receive 6 sessions (2 per week) with average 6,000 shocks per session with the PiezoWave2 unit

Device: LI-ESWT

Medical Treatment Group

ACTIVE COMPARATOR

This group will receive self-administered Tadalafil on-demand

Drug: Tadalafil 20Mg Oral Tablet

Interventions

LI-ESWTDEVICE

Low intenisty shockwave therapy newly used for treatment of erectile dysfunction by applying 6 sessions on 3 weeks (2 sessions /week)

Also known as: Shockwave therapy
Shockwave group
Tadalafil 20Mg Oral TabletDRUG

Patients on this arm will allocate on on-demand tadalafil 20 mg for treatment of ED

Medical Treatment Group

Eligibility Criteria

Age25 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male patients
  • ED at least for 6 months
  • vasculogenic ED
  • from 25-60 years old

You may not qualify if:

  • psychological patents
  • neurological patients
  • younger than 25 years old
  • older than 60 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University

Cairo, 32632, Egypt

RECRUITING

Related Publications (3)

  • Dong L, Chang D, Zhang X, Li J, Yang F, Tan K, Yang Y, Yong S, Yu X. Effect of Low-Intensity Extracorporeal Shock Wave on the Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis. Am J Mens Health. 2019 Mar-Apr;13(2):1557988319846749. doi: 10.1177/1557988319846749.

    PMID: 31027441BACKGROUND

  • Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13.

    PMID: 27986492BACKGROUND

  • Mo DS, Zhan XX, Shi HW, Cai HC, Meng J, Zhao J, Shang XJ. [Efficacy and safety of low-intensity extracorporeal shock wave therapy in the treatment of ED: A meta-analysis of randomized controlled trials]. Zhonghua Nan Ke Xue. 2019 Mar;25(3):257-264. Chinese.

    PMID: 32216245BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Extracorporeal Shockwave TherapyTadalafilTablets

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationCarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingDosage FormsPharmaceutical Preparations

Study Officials

  • fouad zanaty, professor

    Menoufia University

    STUDY DIRECTOR

Central Study Contacts

HOSAM KOTB, master

CONTACT

01022707580hosam.kotb2020@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 20, 2022

Study Start

September 1, 2021

Primary Completion

March 1, 2022

Study Completion

May 1, 2022

Last Updated

January 20, 2022

Record last verified: 2022-01

Locations

EG(1)