Penile Implant Intraoperative Measurements Planning Chart (PIIMP)

September 11, 2022 updated by: Adham ZAAZAA, Cairo University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt, 12578
        • Recruiting
        • Adham ZAAZAA
        • Contact:
    • الجيزة
      • Giza, الجيزة, Egypt, 12578
        • Recruiting
        • Adham ZAAZAA
        • Contact:
        • Principal Investigator:
          • Adham Zaazaa, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Erectile dysfunction not responding to medical treatment

Exclusion Criteria:

  • Patients refusing penile prosthesis implantation as a treatment modality for their erectile dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients undergoing Penile Implant Surgery

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
Penile measurement are taken preoperatively to serve as a guide to the surgeon to optimize post-operative penile size.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

September 4, 2022

Study Completion (Anticipated)

October 6, 2022

Study Registration Dates

First Submitted

September 4, 2022

First Submitted That Met QC Criteria

September 4, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 11, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIIMP Chart

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Erectile Dysfunction

Clinical Trials on Penile Prosthesis Implantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe