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

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ClinicalTrials.gov Identifier: NCT03449940
Recruitment Status : Completed
First Posted : February 28, 2018
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
University Hospital of the West Indies
Information provided by (Responsible Party):
Dean Wong, Ministry of Health, Jamaica

Brief 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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Procedure: Immediate repair Procedure: Delayed repair Drug: Lidocaine Drug: Ceftriaxone Drug: Diclofenac Sodium Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Penile Fracture: A Prospective Randomized Study Comparing Erectile Function at 12 Months After Immediate Degloving Repair Versus Delayed Localized Repair
Actual Study Start Date : January 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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 Name: 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.

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 Name: Local Anaesthesia

Drug: Ceftriaxone
Pre-operative antibiotic given to all patients. Ceftriaxone 1g is administered intravenously.
Other Name: Antibiotic

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 Name: Analgesic




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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".

  2. 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".

  3. 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".

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449940


Locations
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Jamaica
Kingston Public Hospital
Kingston, Jamaica
University Hospital of the West Indies
Kingston, Jamaica
Sponsors and Collaborators
Ministry of Health, Jamaica
University Hospital of the West Indies
Investigators
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Study Director: Belinda Morrison, DM(Urol) PhD University of the West Indies

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Responsible Party: Dean Wong, Principal Investigator, Ministry of Health, Jamaica
ClinicalTrials.gov Identifier: NCT03449940     History of Changes
Other Study ID Numbers: 4200
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dean Wong, Ministry of Health, Jamaica:
Penile fracture
Delayed
Localized
Repair
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Anti-Bacterial Agents
Ceftriaxone
Diclofenac
Lidocaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors