Penile Implant Intraoperative Measurements Planning Chart

NCT ID: NCT05531877

Last Updated: 2022-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-10-06

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Penile Prosthesis Implantation

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Penile Prosthesis Implantation

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Erectile dysfunction not responding to medical treatment

Exclusion Criteria

* Patients refusing penile prosthesis implantation as a treatment modality for their erectile dysfunction
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Adham ZAAZAA

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Adham ZAAZAA

Giza, , Egypt

Site Status RECRUITING

Adham ZAAZAA

Giza, الجيزة, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Adham Zaazaa

Role: CONTACT

+201227427049

Facility Contacts

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Adham ZAAZAA, MD PhD MRCS

Role: primary

+201227427049

Adham ZAAZAA, PhD

Role: primary

+201227427049

References

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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.

Reference Type BACKGROUND
PMID: 34257646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30773500 (View on PubMed)

Other Identifiers

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PIIMP Chart

Identifier Type: -

Identifier Source: org_study_id

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