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
24 participants
INTERVENTIONAL
2019-01-01
2021-05-01
Brief Summary
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Detailed Description
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Introducing and evaluating the accuracy of a novel method for estimating inflatable penile prosthesis cylinders length.
Methods:
24 patients undergoing a Coloplast Titan ® Touch implantation procedure will berandomly divided into two groups.
The "Tumescent Stretching Measurement Technique" (TSMT) group (N=12) will be administered an intracorporal injection (ICI) of 20 microgram Alprostadil. Hegar 7 dilator will be introduced through the corporotomy until reaching a bone stopping point. The tumescent penis will be stretched maximally, and the proximally inserted dilator measured externally to the coronal sulcus.
The control group (N=12) will receive no intraoperative ICI. Following maximal corporal dilatation, cylinder length will be estimated by adding up the internally measured distal and proximal corpora to the length of the corporotomy.
Implants are deemed correctly sized when cylinders reached the proximal third of the glans with no buckling of cylinders or floppy glans.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tumescent Stretching Measurement Technique
The "Tumescent Stretching Measurement Technique" (TSMT) group (N=12) will be administered an intracorporal injection (ICI) of 20 microgram Alprostadil. Hegar 7 dilator will be introduced through the corporotomy until reaching a bone stopping point. The tumescent penis will stretched maximally, and the proximally inserted dilator measured externally to the coronal sulcus.
Tumescent Stretching Measurement Technique
The "Tumescent Stretching Measurement Technique" (TSMT) group (N=12) will be administered an intracorporal injection (ICI) of 20 microgram Alprostadil. Hegar 7 dilator will be introduced through the corporotomy until reaching a bone stopping point. The tumescent penis will stretched maximally, and the proximally inserted dilator measured externally to the coronal sulcus.
Conventional Measurement technique
The control group (N=12) will receive no intraoperative ICI. Following maximal corporal dilatation, cylinder length will be estimated conventionally by adding up the internally measured distal and proximal corpora to the length of the corporotomy.
Tumescent Stretching Measurement Technique
The "Tumescent Stretching Measurement Technique" (TSMT) group (N=12) will be administered an intracorporal injection (ICI) of 20 microgram Alprostadil. Hegar 7 dilator will be introduced through the corporotomy until reaching a bone stopping point. The tumescent penis will stretched maximally, and the proximally inserted dilator measured externally to the coronal sulcus.
Interventions
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Tumescent Stretching Measurement Technique
The "Tumescent Stretching Measurement Technique" (TSMT) group (N=12) will be administered an intracorporal injection (ICI) of 20 microgram Alprostadil. Hegar 7 dilator will be introduced through the corporotomy until reaching a bone stopping point. The tumescent penis will stretched maximally, and the proximally inserted dilator measured externally to the coronal sulcus.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
\-
21 Years
79 Years
MALE
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Adham ZAAZAA
Associate Professor
Locations
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Cairo University
Cairo, , Egypt
Countries
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Other Identifiers
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TSMT
Identifier Type: -
Identifier Source: org_study_id
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