NCT06743048

Brief Summary

A surgical technique using laser assisted penile prosthesis implantation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

2.3 years

First QC Date

December 16, 2024

Last Update Submit

December 16, 2024

Conditions

Erectile DysfunctionErectile Dysfunction Associated With Type 2 Diabetes MellitusErectile Dysfunction Due to Arterial DiseaseErectile Dysfunction Due to Arterial InsufficiencyErectile Dysfunction Due to Venous DisorderErectile Dysfunction Due to NeuropathyErectile Dysfunction Following Radical Prostatectomy

Keywords

Cavernosal tissue sparing laser assisted implantation

Outcome Measures

Primary Outcomes (1)

  • Successful Penile prosthesis implantation

    The penile implant is successfully implanted

    1 hour

Study Arms (1)

TSLA Group

OTHER

Tissue Sparing Laser Assisted Penile Implantation

Procedure: Tissue Sparing Laser Implantation

Interventions

Tissue Sparing Laser ImplantationPROCEDURE

A penile implant will be implanted using the cavernosal sparing technique and assisted by a laser fibre optic

TSLA Group

Eligibility Criteria

Age21 Years - 81 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly Males requiring penile implants
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men with ED not responding to medical treatment

You may not qualify if:

  • Men with HBA1c more than 10

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Nada Hospital

Cairo, Egypt

Location

Related Publications (1)

  • Zaazaa A, Mostafa T. Spontaneous Penile Tumescence by Sparing Cavernous Tissue in the Course of Malleable Penile Prosthesis Implantation. J Sex Med. 2019 Mar;16(3):474-478. doi: 10.1016/j.jsxm.2019.01.012. Epub 2019 Feb 14.

    PMID: 30773500BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Andrology

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 19, 2024

Study Start

July 1, 2022

Primary Completion

November 1, 2024

Study Completion

November 30, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Sensitive data

Locations

EG(1)