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Erectile DysfunctionNCT03449940

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

A study testing Immediate repair, Delayed repair and Lidocaine in people with Erectile Dysfunction, run by Ministry of Health, Jamaica at 2 sites in Jamaica.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Immediate repair, Delayed repair and Lidocaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
2 sitesJamaica
Study dates
Jan 2015to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men with penile fracture presenting to the emergency room

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Jamaica2 sites

  • Kingston Public Hospital

    Kingston

  • University Hospital of the West Indies

    Kingston

Other trials in Jamaica

About this study

Official title: 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.

Read the 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.

Being tested
Immediate repair, Delayed repair, Lidocaine, Ceftriaxone, Diclofenac Sodium
Keywords
Penile fracture, Delayed, Localized, Repair
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immediate repairProcedure or surgery

  • Delayed repairProcedure or surgery

  • LidocaineDrug

    Also called Local Anaesthesia

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

  • CeftriaxoneDrug

    Also called Antibiotic

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

  • Diclofenac SodiumDrug

    Also called Analgesic

    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.

Study groups in NCT03449940
Study groupRoleWhat they receive
Immediate repair (group 1)Active comparatorPenile 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.
Receives: Procedure: Immediate repair; Drug: Ceftriaxone
Delayed repair (group 2)Active comparatorPatients 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.
Receives: Procedure: Delayed repair; Drug: Lidocaine; Drug: Ceftriaxone; Drug: Diclofenac Sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 months

Secondary outcomes (4)

  1. 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".

    Measured: 12 months

  2. 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".

    Measured: 12 months

  3. Penile curvature

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

    Measured: 12 months

  4. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2018
  2. Study startJan 2015
  3. Primary completionJan 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03449940
Sponsor's protocol ID
4200
Status last verified
Feb 2018
First submitted
11 Feb 2018
Last updated
1 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Immediate repair, Delayed repair and Lidocaine in people with Erectile Dysfunction, run by Ministry of Health, Jamaica at 2 sites in Jamaica.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Erectile function (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03449940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.

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