NCT03466619

Brief Summary

Erectile dysfunction (ED) is defined as the persistent inability to attain and or maintain an erection sufficient to permit satisfactory sexual performance

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress88%
Nov 2014Dec 2027

Study Start

First participant enrolled

November 1, 2014

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

13.1 years

First QC Date

March 9, 2018

Last Update Submit

March 14, 2018

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Number of patients with improved erectile dysfunction

    The number of patients with improved erectile dysfunction

    3 years

Study Arms (1)

inflatable penile prosthesis (IPP)

EXPERIMENTAL

inflatable penile prosthesis (IPP)

Device: inflatable penile prosthesis (IPP)

Interventions

inflatable penile prosthesis (IPP)DEVICE

inflatable penile prosthesis (IPP)

Also known as: penile prosthesis (IPP)
inflatable penile prosthesis (IPP)

Eligibility Criteria

Age18 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients complaining of ED with contraindication or failure of medical treatment

You may not qualify if:

  • Patients lacking manual dexterity or mental abilities necessary to operate the pump
  • General contraindications as uncorrectable bleeding tendency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university - faculty of medicine

Cairo, Elgharbia, Egypt

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Penile Prosthesis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Khaled Mohamed Hafez Morsy Almekaty, Msc

    Urology Department- Tanta University

    PRINCIPAL INVESTIGATOR

  • Samir Abdelhakim Elgamal, Prof

    Urology Department- Tanta University

    PRINCIPAL INVESTIGATOR

  • Suks Minhas, Prof

    Professor of urology University College London Hospital(UCLH)London, UK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, MD

CONTACT

00201095159522sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: inflatable penile prosthesis (IPP)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 15, 2018

Study Start

November 1, 2014

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

EG(1)