An interventional study of Immediate repair and Delayed repair in Erectile Dysfunction, sponsored by Ministry of Health, Jamaica. Completed at 2 sites in Jamaica. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-01.
Sponsored by Ministry of Health, Jamaica · Not applicable, Interventional, and Treatment
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.
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.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's enrollment of 46 is below the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.
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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
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
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
Pre-operative antibiotic given to all patients. Ceftriaxone 1g is administered intravenously.
Also known as: Antibiotic
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
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).
Time frame: 12 months
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".
Time frame: 12 months
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".
Time frame: 12 months
Penile curvature
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
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.
Time frame: 12 months
Plan to share: No
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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lidocaine · Diclofenac