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

February 27, 2018 updated by: Dean Wong, Ministry of Health, Jamaica

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jamaica
      • Kingston, Jamaica
        • Kingston Public Hospital
      • Kingston, Jamaica
        • University Hospital of the West Indies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate repair (group 1)

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
Drug: Ceftriaxone
Pre-operative antibiotic given to all patients. Ceftriaxone 1g is administered intravenously.
Other Names:
  • Antibiotic
Active Comparator: Delayed repair (group 2)

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.
Drug: Ceftriaxone
Pre-operative antibiotic given to all patients. Ceftriaxone 1g is administered intravenously.
Other Names:
  • Antibiotic
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.
Other Names:
  • Local Anaesthesia
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.
Other Names:
  • Analgesic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erectile function
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Jamaica

Collaborators

University Hospital of the West Indies

Investigators

  • Study Director: Belinda Morrison, DM(Urol) PhD, University of the West Indies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 11, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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