Penile Implant Intraoperative Measurements Planning Chart

Erectile Dysfunction Clinical Trial

— PIIMP  

Official title:

Penile Implant Intraoperative Measurements Planning Chart

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531877
• Other study ID #: PIIMP Chart
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: October 6, 2022

Study information

• Verified date: September 2022
• Source: Cairo University
• Contact: Adham Zaazaa
• Phone: +201227427049
• Email: adhamzaazaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 6, 2022
• Est. primary completion date: September 4, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 99 Years

Eligibility

Inclusion Criteria:

• Erectile dysfunction not responding to medical treatment

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Endocrine System Diseases
• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy
• Erectile Dysfunction Following Simple Prostatectomy
• Erectile Dysfunction With Diabetes Mellitus

Intervention

Diagnostic Test:
• Penile Prosthesis Implantation
Penile measurement are taken preoperatively to serve as a guide to the surgeon to optimize post-operative penile size.

Locations

Country	Name	City	State
Egypt	Adham ZAAZAA	Giza
Egypt	Adham ZAAZAA	Giza	??????

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No oversizing	Post-operative Penile Length did not exceed pre-operative pharmacologically induced erect stretched length	Intraoperative
Primary	No undersizing	Post-operative penile length not less than pre-operative pharmacologically induced erect non-stretched penile length	Intraoperative
Secondary	Adequate Girth	Post operative penile circumference not less than pre-operative pharmacologically induced erect stretched circumference	Intraoperative