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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Procedure: Immediate repair
* Procedure: Delayed repair
* Drug: Lidocaine
* Drug: Ceftriaxone
* Drug: Diclofenac Sodium


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate repair (group 1)<br>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. | Procedure: Immediate repair<br> <br> Drug: Ceftriaxone<br>* Pre-operative antibiotic given to all patients. Ceftriaxone 1g is administered intravenously.<br>* Other names: Antibiotic;|
| Active Comparator: Delayed repair (group 2)<br>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. | Procedure: Delayed repair<br> <br> Drug: Lidocaine<br>* 10cc of Lidocaine 1% is used to inject at the base of the penis for a dorsal penile nerve block for the localized repair.<br>* Other names: Local Anaesthesia;Drug: Ceftriaxone<br>* Pre-operative antibiotic given to all patients. Ceftriaxone 1g is administered intravenously.<br>* Other names: Antibiotic;Drug: Diclofenac Sodium<br>* 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.<br>* Other names: Analgesic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile function | 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penile nodule | 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. | 12 months | 
| Penile pain during sexual intercourse | The patient is asked if there is pain in the penis during sexual intercourse. It is recorded as present or not present. | 12 months | 
| Penile curvature | The patient is asked if there is an acquired curvature of the erect penis. It is recorded as present or not present. | 12 months | 
| Patient satisfaction | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Penile fracture, Delayed, Localized, Repair