NCT05531877

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

2.1 years

First QC Date

September 4, 2022

Last Update Submit

September 11, 2022

Conditions

Erectile DysfunctionErectile Dysfunction Following Radical ProstatectomyErectile Dysfunction With Diabetes MellitusErectile Dysfunction Due to Arterial DiseaseErectile Dysfunction Due to InjuryErectile Dysfunction Due to NeuropathyErectile Dysfunction Following Simple ProstatectomyErectile Dysfunction Due to Venous DisorderErectile Dysfunction With Type 1 Diabetes MellitusErection; IncompleteErectile Dysfunction Due to Endocrine Disease

Keywords

Erectile DysfunctionPenile ImplantPenile prosthesis

Outcome Measures

Primary Outcomes (2)

  • No oversizing

    Post-operative Penile Length did not exceed pre-operative pharmacologically induced erect stretched length

    Intraoperative

  • No undersizing

    Post-operative penile length not less than pre-operative pharmacologically induced erect non-stretched penile length

    Intraoperative

Secondary Outcomes (1)

  • Adequate Girth

    Intraoperative

Study Arms (1)

Patients undergoing Penile Implant Surgery

EXPERIMENTAL

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.

Diagnostic Test: Penile Prosthesis Implantation

Interventions

Penile Prosthesis ImplantationDIAGNOSTIC_TEST

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

Patients undergoing Penile Implant Surgery

Eligibility Criteria

Age21 Years - 99 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Erectile dysfunction not responding to medical treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Adham ZAAZAA

Giza, 12578, Egypt

RECRUITING

Adham ZAAZAA

Giza, الجيزة, 12578, Egypt

RECRUITING

Related 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.

    PMID: 34257646BACKGROUND

  • 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.

    PMID: 30773500BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Central Study Contacts

Adham Zaazaa

CONTACT

+201227427049adhamzaazaa@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 4, 2022

First Posted

September 8, 2022

Study Start

August 1, 2020

Primary Completion

September 4, 2022

Study Completion

October 6, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

IPD shared within 1 year of publishing upon reasonable request

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
For one year from publishing the results
Access Criteria
Upon reasonable request

Locations

EG(2)