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

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Jamaica
Study Type
Interventional
Intervention
Immediate repair
Delayed repair
Lidocaine
Ceftriaxone
Diclofenac Sodium
Sponsored by
Ministry of Health, Jamaica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Penile fracture, Delayed, Localized, Repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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)

Sites / Locations

  • Kingston Public Hospital
  • University Hospital of the West Indies

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Immediate repair (group 1)

Delayed repair (group 2)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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".
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".
Penile curvature
The patient is asked if there is an acquired curvature of the erect penis. It is recorded as "present" or "not present".
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.

Full Information

First Posted
February 11, 2018
Last Updated
February 27, 2018
Sponsor
Ministry of Health, Jamaica
Collaborators
University Hospital of the West Indies
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1. Study Identification

Unique Protocol Identification Number
NCT03449940
Brief Title
Penile Fracture: A Comparison of Erectile Function After Immediate Repair Versus Delayed Repair
Official Title
Penile Fracture: A Prospective Randomized Study Comparing Erectile Function at 12 Months After Immediate Degloving Repair Versus Delayed Localized Repair
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Jamaica
Collaborators
University Hospital of the West Indies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Penile fracture, Delayed, Localized, Repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate repair (group 1)
Arm Type
Active Comparator
Arm 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.
Arm Title
Delayed repair (group 2)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Immediate repair
Intervention Type
Procedure
Intervention Name(s)
Delayed repair
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Local Anaesthesia
Intervention Description
10cc of Lidocaine 1% is used to inject at the base of the penis for a dorsal penile nerve block for the localized repair.
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Other Intervention Name(s)
Antibiotic
Intervention Description
Pre-operative antibiotic given to all patients. Ceftriaxone 1g is administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Diclofenac Sodium
Other Intervention Name(s)
Analgesic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Erectile function
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Penile nodule
Description
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".
Time Frame
12 months
Title
Penile pain during sexual intercourse
Description
The patient is asked if there is pain in the penis during sexual intercourse. It is recorded as "present" or "not present".
Time Frame
12 months
Title
Penile curvature
Description
The patient is asked if there is an acquired curvature of the erect penis. It is recorded as "present" or "not present".
Time Frame
12 months
Title
Patient satisfaction
Description
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.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belinda Morrison, DM(Urol) PhD
Organizational Affiliation
University of the West Indies
Official's Role
Study Director
Facility Information:
Facility Name
Kingston Public Hospital
City
Kingston
Country
Jamaica
Facility Name
University Hospital of the West Indies
City
Kingston
Country
Jamaica

12. IPD Sharing Statement

Plan to Share IPD
No

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

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