Penile Implant Intraoperative Measurements Planning Chart

Study Overview
=================
Brief Summary
-----------------
This is a chart of penile size measurements where penile length and width are recorded intra-operatively prior to penile prosthesis implantation to guide the surgeon to the correct and adequate post-operative penile size

Detailed Description
-----------------
The chart records preoperative penile dimensions as penile length and circumference both relaxed and stretched, both in a de-tumescent and erect state, before after intra-operative injection of 1cc Prostaglandin E1 respectively, to enhance pharmacological tumescence. The implantation of the penile implant will resume with the cavernosal sparing technique. After the penile prosthesis has been implanted, penile length and girth will be measured and the penile implant dimensions will be recorded in the chart. The PIMP chart will assist the surgeon in assuring he sized the penis most adequately with the implant by taking the penile dimensions ( Length and Circumference). To assure that the penis was not oversized with the implant, the post-operative penile length should not exceed the pre-operative penile tumescent stretched length. To assure that the penis was not undersized, the postoperative penile length should not be less than the pre-operative tumescent non-stretched penile length.. The chart will also document the patients' penile dimensions pre and post operatively and could be used as an objective tool for post-operative patient counseling and reassurance about the results of the penile implant surgery.

Official Title
-----------------
Penile Implant Intraoperative Measurements Planning Chart

Conditions
-----------------
Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction With Diabetes Mellitus, Erectile Dysfunction Due to Arterial Disease, Erectile Dysfunction Due to Injury, Erectile Dysfunction Due to Neuropathy, Erectile Dysfunction Following Simple Prostatectomy, Erectile Dysfunction Due to Venous Disorder, Erectile Dysfunction With Type 1 Diabetes Mellitus, Erection; Incomplete, Erectile Dysfunction Due to Endocrine Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Penile Prosthesis Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Erectile dysfunction not responding to medical treatment Exclusion Criteria: Patients refusing penile prosthesis implantation as a treatment modality for their erectile dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: The P.I.M.P Chart will be hung on the operative room wall and penile measurements pre and post operatively recorded as the surgery progresses together with the Penile Implant size.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing Penile Implant Surgery<br>All intraoperative measurements are documented in real time. Measurements recorded are as follows: Preoperative Pre-ICI penile length and circumference, both in relaxed and stretched states. Preoperative post-ICI penile length and circumference, both in relaxed and stretched states. Postoperative penile length and circumference. Penile implant length and girth. | Diagnostic Test: Penile Prosthesis Implantation<br>* Penile measurement are taken preoperatively to serve as a guide to the surgeon to optimize post-operative penile size.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No oversizing | Post-operative Penile Length did not exceed pre-operative pharmacologically induced erect stretched length | Intraoperative | 
| No undersizing | Post-operative penile length not less than pre-operative pharmacologically induced erect non-stretched penile length | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate Girth | Post operative penile circumference not less than pre-operative pharmacologically induced erect stretched circumference | Intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Penile Implant, Penile prosthesis, Erectile Dysfunction