Penile Implant Intraoperative Measurements Planning Chart (PIIMP)

Cairo University (CU)

Status: Enrolling

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

Treatments: Diagnostic Test: Penile Prosthesis Implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05531877

PIIMP Chart

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Erectile dysfunction not responding to medical treatment

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Patients undergoing Penile Implant Surgery

Experimental group

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.

Treatment:

Diagnostic Test: Penile Prosthesis Implantation