Clinical trial NCT03449940: Penile Fracture: A Comparison of Erectile Function After Immediate Repair Versus Delayed Repair
Official title: Penile Fracture: A Prospective Randomized Study Comparing Erectile Function at 12 Months After Immediate Degloving Repair Versus Delayed Localized Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Penile fracture
Delayed
Localized
Repair
Lead sponsor: Ministry of Health, Jamaica
Sponsor class: OTHER
Collaborators: name: University Hospital of the West Indies
First posted: 2018-02-28
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Erectile function
timeFrame: 12 months
Secondary outcomes:
measure: Penile nodule
timeFrame: 12 months
measure: Penile pain during sexual intercourse
timeFrame: 12 months
measure: Penile curvature
timeFrame: 12 months
measure: Patient satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: Kingston Public Hospital
city: Kingston
country: Jamaica
facility: University Hospital of the West Indies
Study officials:
affiliation: University of the West Indies
name: Belinda Morrison, DM(Urol) PhD
role: STUDY_DIRECTOR
References: