Skip to main content
OpenTrials
Completed

NCT Number: NCT03449940

Penile Fracture: A Comparison of Erectile Function After Immediate Repair Versus Delayed Repair

To prospectively compare erectile function at 12 months, utilizing the abbreviated International Index of Erectile Function-5 (IIEF-5) score, for men treated with an immediate repair versus a delayed repair.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kingston Public Hospital, Kingston, Jamaica

Loading trial locations.

About this study

This was a prospective randomized study conducted at 2 tertiary level institutions in Jamaica, the University Hospital of the West Indies (UHWI) and the Kingston Public Hospital (KPH). All cases of penile fracture were recruited from the emergency room (ER) of both hospitals between the period January 2015 to January 2017 and all patients were over 18 years of age.

Information on demographics, length of time since the injury, mechanism of injury and risk factors for erectile dysfunction (Diabetes mellitus, Hypertension, Dyslipidemia, Smoking) was collected. Erectile function was objectively assessed utilizing the abbreviated International Index for Erectile Function-5 (IIEF-5), and scores at initial presentation were taken to represent the premorbid erectile function.

A block randomization sequence was created and cases were allocated 1:1 to either immediate repair (group 1) or delayed repair (group 2). Allocation sequence numbers were kept concealed in sequentially numbered folders and access was only granted to the principal investigator.

For Group 1 (Immediate repair)

Patients were admitted to hospital and underwent emergency repair via a subcoronal circumferential degloving approach.

For Group 2 (Delayed repair)

Patients were not admitted. Instead, they were discharged from hospital and given an elective surgery date 7 - 10 days after the injury. Oral Diclofenac Sodium 50mg was prescribed to be taken as needed and instructions to abstain from any sexual activity.

All patients were then re-examined at 6 weeks for quality assurance. They were then instructed that resumption of sexual activity would be safe.

Routine clinic visits were scheduled at 3 months, 6 months, and 12 months. IIEF-5 scores were obtained from all patients at 12months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men with penile fracture presenting to the emergency room

Exclusion criteria

  • Suspicion of concomitant urethral injury (blood at the meatus, gross/microscopic haematuria, urinary retention)

Treatment and study plan

Immediate repair

Procedure

Delayed repair

Procedure

Lidocaine

Drug

10cc of Lidocaine 1% is used to inject at the base of the penis for a dorsal penile nerve block for the localized repair.

Other names: Local Anaesthesia

Ceftriaxone

Drug

Pre-operative antibiotic given to all patients. Ceftriaxone 1g is administered intravenously.

Other names: Antibiotic

Diclofenac Sodium

Drug

Oral Diclofenac Sodium 50mg tablet is prescribed to be taken as needed up to a maximum of three times daily until the penis is repaired.

Other names: Analgesic

Primary outcomes

  1. Erectile function

    Time frame: 12 months

    The International Index of Erectile Function (IIEF-5) is recorded as a total score. It is measured by a self-reported questionnaire with 5 domains, with each domain consisting of 5 options. The score ranges from 5 to 25, with 5 being the lowest score (severe erectile dysfunction) and 25 being the best score (maximal erection).

Secondary outcomes

  1. Penile nodule

    Time frame: 12 months

    The penis is examined and palpated for the presence of nodule formation at the fracture repair site. It is recorded as "present" or "not present".

  2. Penile pain during sexual intercourse

    Time frame: 12 months

    The patient is asked if there is pain in the penis during sexual intercourse. It is recorded as "present" or "not present".

  3. Penile curvature

    Time frame: 12 months

    The patient is asked if there is an acquired curvature of the erect penis. It is recorded as "present" or "not present".

  4. Patient satisfaction

    Time frame: 12 months

    The Surgical Satisfaction Questionnaire (SSQ-8) is administered. There are 8 questions with 5 possible options in each domain. The questionnaire results are recorded as descriptive terms for each domain.

Sponsors and collaborators

Lead sponsor

Ministry of Health, Jamaica

Other

Collaborators

  • University Hospital of the West Indies

Registry information

Official study title

Penile Fracture: A Prospective Randomized Study Comparing Erectile Function at 12 Months After Immediate Degloving Repair Versus Delayed Localized Repair

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 28, 2018
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.