A Tissue Sparing, Laser Assisted Penile Prosthesis Implantation Technique

NCT ID: NCT06743048

Last Updated: 2024-12-19

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

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-11-30

Brief Summary

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A surgical technique using laser assisted penile prosthesis implantation

Detailed Description

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A surgical technique using deep-red laser diode for visualization of the implantation track of the penile implant or Holium Laser for clearing the track whenever it is obstructed by fibrotic tissue.

Conditions

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Erectile Dysfunction Erectile Dysfunction Associated With Type 2 Diabetes Mellitus Erectile Dysfunction Due to Arterial Disease Erectile Dysfunction Due to Arterial Insufficiency Erectile Dysfunction Due to Venous Disorder Erectile Dysfunction Due to Neuropathy Erectile Dysfunction Following Radical Prostatectomy

Keywords

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Cavernosal tissue sparing laser assisted implantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TSLA Group

Tissue Sparing Laser Assisted Penile Implantation

Group Type OTHER

Tissue Sparing Laser Implantation

Intervention Type PROCEDURE

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

Interventions

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Tissue Sparing Laser Implantation

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Men with ED not responding to medical treatment

Exclusion Criteria

* Men with HBA1c more than 10
Minimum Eligible Age

21 Years

Maximum Eligible Age

81 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Adham ZAAZAA

Associate Professor Andrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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El Nada Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 30773500 (View on PubMed)

Other Identifiers

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TSLA_Implantation

Identifier Type: -

Identifier Source: org_study_id