Cavernous Tissue Preservation During Penile Prosthesis Implantation
NCT ID: NCT03733860
Last Updated: 2018-11-08
Study Results
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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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-11-01
2018-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cavernous sparing group
Cavernous tissue sparing penile prosthesis implantation
Beginning penile prosthesis implantation (Coloplast Titan USA) procedure after intracavenosal injection of PGE1 prostine.
Intracavernosal injection of alprostadil
Intraoperative intracavernosal injection of alprostadil in the cavernous sparing group
Conventional technique group
Conventional penile prosthesis implantation
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.
Conventional penile prosthesis implantation
Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine
Intracavernosal injection of alprostadil
Intraoperative intracavernosal injection of alprostadil in the cavernous sparing group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
81 Years
MALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Adham Zaazaa
Assistant Lecturer
Principal Investigators
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Adham Zaazaa, PhD
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Cairo University
Cairo, , Egypt
Countries
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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.
Other Identifiers
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AZ2017
Identifier Type: -
Identifier Source: org_study_id
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