Penile Implant Intraoperative Measurements Planning Chart (PIIMP)
Primary Purpose
Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction With Diabetes Mellitus
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Penile Prosthesis Implantation
Sponsored by
About this trial
This is an interventional supportive care trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Penile Implant, Penile prosthesis
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
Sites / Locations
- Adham ZAAZAARecruiting
- Adham ZAAZAARecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients undergoing Penile Implant Surgery
Arm Description
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.
Outcomes
Primary Outcome Measures
No oversizing
Post-operative Penile Length did not exceed pre-operative pharmacologically induced erect stretched length
No undersizing
Post-operative penile length not less than pre-operative pharmacologically induced erect non-stretched penile length
Secondary Outcome Measures
Adequate Girth
Post operative penile circumference not less than pre-operative pharmacologically induced erect stretched circumference
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05531877
Brief Title
Penile Implant Intraoperative Measurements Planning Chart
Acronym
PIIMP
Official Title
Penile Implant Intraoperative Measurements Planning Chart
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
September 4, 2022 (Actual)
Study Completion Date
October 6, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Erectile Dysfunction, Penile Implant, Penile prosthesis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing Penile Implant Surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Penile Prosthesis Implantation
Intervention Description
Penile measurement are taken preoperatively to serve as a guide to the surgeon to optimize post-operative penile size.
Primary Outcome Measure Information:
Title
No oversizing
Description
Post-operative Penile Length did not exceed pre-operative pharmacologically induced erect stretched length
Time Frame
Intraoperative
Title
No undersizing
Description
Post-operative penile length not less than pre-operative pharmacologically induced erect non-stretched penile length
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Adequate Girth
Description
Post operative penile circumference not less than pre-operative pharmacologically induced erect stretched circumference
Time Frame
Intraoperative
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adham Zaazaa
Phone
+201227427049
Email
adhamzaazaa@gmail.com
Facility Information:
Facility Name
Adham ZAAZAA
City
Giza
ZIP/Postal Code
12578
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adham ZAAZAA, MD PhD MRCS
Phone
+201227427049
Email
adhamzaazaa@gmail.com
Facility Name
Adham ZAAZAA
City
Giza
State/Province
الجيزة
ZIP/Postal Code
12578
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adham ZAAZAA, PhD
Phone
+201227427049
Email
adhamzaazaa@gmail.com
First Name & Middle Initial & Last Name & Degree
Adham Zaazaa, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD shared within 1 year of publishing upon reasonable request
IPD Sharing Time Frame
For one year from publishing the results
IPD Sharing Access Criteria
Upon reasonable request
Citations:
PubMed Identifier
34257646
Citation
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.
Results Reference
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PubMed Identifier
30773500
Citation
Zaazaa A, Mostafa T. Spontaneous Penile Tumescence by Sparing Cavernous Tissue in the Course of Malleable Penile Prosthesis Implantation. J Sex Med. 2019 Mar;16(3):474-478. doi: 10.1016/j.jsxm.2019.01.012. Epub 2019 Feb 14.
Results Reference
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Penile Implant Intraoperative Measurements Planning Chart
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