Penile Prosthesis in Patients With Erectile Dysfunction | NCT03466619

Studies
Penile Prosthesis in Patients With Erectile Dysfunction

NCT03466619

Sponsor

Tanta University

Status

Recruiting

Last Update Posted

Mar 15, 2018Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Erectile Dysfunction

Interventions

inflatable penile prosthesis (IPP)

Countries

Egypt

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2014Actual

Primary Completion Date

Dec 1, 2027Estimated

Completion Date

Dec 1, 2027Estimated

First Submitted Date

Mar 9, 2018

First Submission Date that Met QC Criteria

Mar 14, 2018

First Posted Date

Mar 15, 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

Mar 14, 2018

Last Update Posted Date

Mar 15, 2018Actual

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

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

Detailed Description

In the literature, well- designed studies evaluating safety and efficacy of inflatable penile prosthesis (IPP) is lacking. So, this series aimed at investigating this prospectively.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
inflatable penile prosthesis (IPP)	Experimental	inflatable penile prosthesis (IPP)	Device: inflatable penile prosthesis (IPP)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inflatable penile prosthesis (IPP)	Device	inflatable penile prosthesis (IPP)	inflatable penile prosthesis (IPP)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with improved erectile dysfunction	The number of patients with improved erectile dysfunction	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients complaining of ED with contraindication or failure of medical treatment

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Males

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, MD	Contact	00201095159522		sheriefabdelsalam@yahoo.com

Overall Officials

Name	Affiliation	Role
Khaled Mohamed Hafez Morsy Almekaty, Msc	Urology Department- Tanta University	Principal Investigator
Samir Abdelhakim Elgamal, Prof	Urology Department- Tanta University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta university - faculty of medicine	Recruiting	Cairo	Elgharbia		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

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
D015917	Penile Prosthesis

Ancestor Terms

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided