Penile Implant Intraoperative Measurements Planning Chart

Not Applicable

Recruiting

• Conditions: Erectile Dysfunction; Erectile Dysfunction Following Simple Prostatectomy; Erectile Dysfunction With Type 1 Diabetes Mellitus; Erectile Dysfunction Due to Venous Disorder; Erection; Incomplete; Erectile Dysfunction Due to Endocrine Disease; Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction With Diabetes Mellitus; Erectile Dysfunction Due to Injury; Erectile Dysfunction Due to Neuropathy
• Interventions: Diagnostic Test: Penile Prosthesis Implantation

• Registration Number: NCT05531877
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2020-08-01
• Status Verified: 2022-09
• Primary Completion: 2022-09-04
• Study First Submitted: 2022-09-04
• Study First Submitted QC: 2022-09-04
• Study First Posted: 2022-09-08
• Last Update Submitted: 2022-09-11
• Last Update Posted: 2022-09-14
• Study Completion: 2022-10-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing Penile Implant Surgery	Penile Prosthesis Implantation	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.

Primary Outcome Measures

Name	Time	Method
No oversizing	Intraoperative	Post-operative Penile Length did not exceed pre-operative pharmacologically induced erect stretched length
No undersizing	Intraoperative	Post-operative penile length not less than pre-operative pharmacologically induced erect non-stretched penile length

Secondary Outcome Measures

Name	Time	Method
Adequate Girth	Intraoperative	Post operative penile circumference not less than pre-operative pharmacologically induced erect stretched circumference

Trial Locations

Locations (1)

Adham ZAAZAA; 🇪🇬 Giza, الجيزة, Egypt