Cavernous Tissue Preservation During Penile Prosthesis Implantation (CTP)

November 7, 2018 updated by: Adham Zaazaa, Cairo University

Preservation of Penile Tumescence by Cavernous Tissue Preservation During Penile Prosthesis Implantation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Erectile dysfunction not amenable to treatment by approved medical therapy

Exclusion Criteria:

  • Erectile dysfunction amenable to treatment by approved medical therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other: Conventional technique group
Procedure: Conventional penile prosthesis implantation
Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cavernous tissue thickness postoperatively measured by ultrasound
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Presence of spontaneous penile tumescence post operatively
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Adham Zaazaa, PhD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 7, 2018

Study Record Updates

Last Update Posted (Actual)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 7, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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