Cavernous Tissue Preservation During Penile Prosthesis Implantation

NCT ID: NCT03733860

Last Updated: 2018-11-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2018-12-31

Brief Summary

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Spontaneous penile tumescence after penile prosthesis implantation has been previously reported as sporadically occurring during implant surgery. This study aims at systematically preserving residual erectile function, by the preservation of the patients' spontaneous penile tumescence by systematically sparing cavernous tissue during penile prosthesis implantation.

Detailed Description

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Patients undergoing the cavernous tissue sparing penile implant procedure will be injected intraoperatively with 40µg alprostadil, a prostaglandin E1 agonist intracorporal injection (ICI). The procedure will begin as soon as maximal tumescence is attained.

In the cavernous sparing group, corporal dilation will be done solely with a size 8 dilator. The insertion of the dilator will be carefully inserted in what we call the path of least resistance. To determine the path of least resistance, the corporotomy is spread apart by pulling on previously set stay sutures. The path of least resistance is the plane with maximum outflow of blood from the intraoperatively pharmaceutically dilated and blood filled corpora cavernosa. This plane can also be anticipated with a preoperative penile duplex.

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cavernous sparing group

Group Type ACTIVE_COMPARATOR

Cavernous tissue sparing penile prosthesis implantation

Intervention Type PROCEDURE

Beginning penile prosthesis implantation (Coloplast Titan USA) procedure after intracavenosal injection of PGE1 prostine.

Intracavernosal injection of alprostadil

Intervention Type PROCEDURE

Intraoperative intracavernosal injection of alprostadil in the cavernous sparing group

Conventional technique group

Group Type OTHER

Conventional penile prosthesis implantation

Intervention Type PROCEDURE

Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine

Interventions

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Cavernous tissue sparing penile prosthesis implantation

Beginning penile prosthesis implantation (Coloplast Titan USA) procedure after intracavenosal injection of PGE1 prostine.

Intervention Type PROCEDURE

Conventional penile prosthesis implantation

Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine

Intervention Type PROCEDURE

Intracavernosal injection of alprostadil

Intraoperative intracavernosal injection of alprostadil in the cavernous sparing group

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Erectile dysfunction not amenable to treatment by approved medical therapy

Exclusion Criteria

* Erectile dysfunction amenable to treatment by approved medical therapy
Minimum Eligible Age

18 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

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adham Zaazaa, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Zaazaa A, Bayerle-Eder M, Elnabarawy R, Elbitar M, Mostafa T. Penile Hemodynamic Response to Phosphodiesterase Type V Inhibitors after Cavernosal Sparing Inflatable Penile Prosthesis Implantation: A Prospective Randomized Open-Blinded End-Point (PROBE) Study. Adv Urol. 2021 Jun 28;2021:5548494. doi: 10.1155/2021/5548494. eCollection 2021.

Reference Type DERIVED
PMID: 34257646 (View on PubMed)

Other Identifiers

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AZ2017

Identifier Type: -

Identifier Source: org_study_id

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