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

NCT03449940 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-03-01

No results posted yet for this study

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

Interventions

PROCEDURE

Immediate repair

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.

DRUG

Ceftriaxone

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

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.

Sponsors & Collaborators

  • University Hospital of the West Indies

    collaborator OTHER

  • Ministry of Health, Jamaica

    lead OTHER

Principal Investigators

  • Belinda Morrison, DM(Urol) PhD · University of the West Indies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-01-31
Completion
2017-12-31

Countries

  • Jamaica

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03449940 on ClinicalTrials.gov