Clinical trial NCT05531877: Penile Implant Intraoperative Measurements Planning Chart
Official title: Penile Implant Intraoperative Measurements Planning Chart
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 200
Sex: MALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: No oversizing
timeFrame: Intraoperative
measure: No undersizing
timeFrame: Intraoperative
Secondary outcomes:
measure: Adequate Girth
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Adham ZAAZAA
city: Giza
country: Egypt
facility: Adham ZAAZAA
state: الجيزة
Study officials:
References:
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.
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.