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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03449940
• Other study ID #: 4200
• Status: Completed
• Phase: N/A
• First received: February 11, 2018
• Last updated: February 27, 2018
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Ministry of Health, Jamaica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Procedure:
• Immediate repair

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

Locations

Country	Name	City	State
Jamaica	Kingston Public Hospital	Kingston
Jamaica	University Hospital of the West Indies	Kingston

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Jamaica	University Hospital of the West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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