NCT03449940

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Ministry of Health, Jamaica · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
PROCEDURE	Immediate repair
PROCEDURE	Delayed repair
DRUG	Lidocaine	10cc of Lidocaine 1% is used to inject at the base of the penis for a dorsal penile nerve block for the localized repair.
DRUG	Ceftriaxone	Pre-operative antibiotic given to all patients. Ceftriaxone 1g is administered intravenously.
DRUG	Diclofenac Sodium	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-01-01
• Completion: 2017-12-01
• First posted: 2018-02-28
• Last updated: 2018-03-01

Locations

2 sites across 1 country: Jamaica