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Cavernous Tissue Preservation During Penile Prosthesis Implantation (CTP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03733860
Recruitment Status : Unknown
Verified November 2018 by Adham Zaazaa, Cairo University.
Recruitment status was:  Active, not recruiting
First Posted : November 7, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Adham Zaazaa, Cairo University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Procedure: Cavernous tissue sparing penile prosthesis implantation Procedure: Conventional penile prosthesis implantation Procedure: Intracavernosal injection of alprostadil Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preservation of Penile Tumescence by Cavernous Tissue Preservation During Penile Prosthesis Implantation
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cavernous sparing group Procedure: Cavernous tissue sparing penile prosthesis implantation
Beginning penile prosthesis implantation (Coloplast Titan USA) procedure after intracavenosal injection of PGE1 prostine.

Procedure: Intracavernosal injection of alprostadil
Intraoperative intracavernosal injection of alprostadil in the cavernous sparing group
Conventional technique group Procedure: Conventional penile prosthesis implantation
Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine


Outcome Measures
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Primary Outcome Measures :
  1. Cavernous tissue thickness postoperatively measured by ultrasound [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Presence of spontaneous penile tumescence post operatively [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Erectile dysfunction not amenable to treatment by approved medical therapy

Exclusion Criteria:

  • Erectile dysfunction amenable to treatment by approved medical therapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733860


Locations
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Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Adham Zaazaa, PhD Cairo University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Adham Zaazaa, Assistant Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03733860    
Other Study ID Numbers: AZ2017
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Adham Zaazaa, Cairo University:
erectile dysfunction
penile tumescence
cavernous tissue
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
 Alprostadil
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents