Tumescent Stretching Measurement Technique

Study Overview
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Brief Summary
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Introducing and evaluating the accuracy of a novel method for estimating inflatable penile prosthesis cylinders length by stretching the tumesncent penis intraoperatively instead of taking proximla and distal measurement to the corporotomy

Detailed Description
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Objectives: 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.

Official Title
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Tumescent Stretching Measurment Technique: A New Technique for Intraoperartive Measurement of Inflatable Penile Implant Size

Conditions
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To Try to Eliminate Frequencies of Insertions in Order to Arrive to Adequate Size of Implanted Penile Prosthesis

Intervention / Treatment
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* Procedure: Tumescent Stretching Measurement Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males needing Penile implant surgery, not responding to oral pharmacological drugs for ttt of ED - Exclusion Criteria: Previouys penile surgery Previous implanted penile prosthesis -

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tumescent Stretching Measurement Technique<br>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. | Procedure: Tumescent Stretching Measurement Technique<br>* 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.<br>|
| Active Comparator: Conventional Measurement technique<br>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. | Procedure: Tumescent Stretching Measurement Technique<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of penile implant insertions and re-insertions needed to arrive to adequate penile implant size | Number of penile implant insertions and re-insertions needed to arrive to adequate penile implant size | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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penile implant, iflatable penile implant, re-insertion, measurement