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

Ministry of Health, Jamaica

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Procedure: Delayed repair; Drug: Ceftriaxone; Procedure: Immediate repair; Drug: Lidocaine; Drug: Diclofenac Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT03449940

4200

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Immediate repair (group 1)

Active Comparator group

Description:

Penile explorations were done within 24 hours of presentation, under general or spinal anaesthesia. 1g Ceftriaxone IV was given. Incision-- Subcoronal, circumferential \& degloving. Repair-- Continuous technique with inverted knots using 3-0 polyglactin suture. All patients were discharged from hospital within 24 hours.

Treatment:

Procedure: Immediate repair

Drug: Ceftriaxone

Delayed repair (group 2)

Active Comparator group

Description:

Patients were not admitted; instead they were discharged from hospital and given an elective surgery date. Oral Diclofenac Sodium 50mg was prescribed to be taken as needed and instructions to abstain from any sexual activity. In an ambulatory setting, surgery was done 7 - 10 days later. 1g Ceftriaxone IV was given. Local anaesthesia (dorsal penile nerve block): 1% Lidocaine 10cc was given. Incision--- 2 - 3cm localized incision over the site of the "rolling" sign. Repair--- Continuous technique with inverted knots using 3-0 polyglactin suture.

Treatment:

Drug: Diclofenac Sodium

Drug: Lidocaine

Procedure: Delayed repair

Drug: Ceftriaxone