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

NCT03449940 | Completed

• 1 other identifier: 4200
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Erectile Dysfunction

Keywords

Penile fracture; Delayed; Localized; Repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Penile nodule

  12 months

• Penile pain during sexual intercourse

  12 months

• Penile curvature

  12 months

• Patient satisfaction

  12 months

Study Arms (2)

Immediate repair (group 1)

ACTIVE COMPARATOR

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

Delayed repair (group 2)

ACTIVE COMPARATOR

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; Drug: Ceftriaxone; Drug: Diclofenac Sodium

Interventions

Immediate repair PROCEDURE

Immediate repair (group 1)

Delayed repair PROCEDURE

Delayed repair (group 2)

Lidocaine DRUG

10cc of Lidocaine 1% is used to inject at the base of the penis for a dorsal penile nerve block for the localized repair.

Also known as: Local Anaesthesia

Delayed repair (group 2)

Ceftriaxone DRUG

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

Also known as: Antibiotic

Delayed repair (group 2); Immediate repair (group 1)

Diclofenac Sodium DRUG

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.

Also known as: Analgesic

Delayed repair (group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men with penile fracture presenting to the emergency room

You may not qualify if:

• Suspicion of concomitant urethral injury (blood at the meatus, gross/microscopic haematuria, urinary retention)

Sponsors & Collaborators

• Ministry of Health, Jamaica: lead
• University Hospital of the West Indies: collaborator

Study Sites (2)

Kingston Public Hospital

Kingston, Jamaica

Location

University Hospital of the West Indies

Kingston, Jamaica

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Lidocaine; Anesthesia, Local; Ceftriaxone; Anti-Bacterial Agents; Diclofenac; Analgesics

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Central Nervous System Agents

Study Officials

• Belinda Morrison, DM(Urol) PhD

  University of the West Indies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: February 28, 2018
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 1, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

JA (2)