An interventional study of Randomization to not receive prophylactic antibiotics after surgery. and Randomization to receive prophylactic antibiotics after surgery in Hypospadias, sponsored by Arkansas Children's Hospital Research Institute. Completed at 1 site in United States. Open to male participants aged 3 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-07.
Sponsored by Arkansas Children's Hospital Research Institute · Not applicable, Interventional, and Treatment
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Among 20 studies in Hypospadias with a site in United States — 4 open to participants now, 5 under way, none of them phase 3. Hypospadias · United States.
Among the 20 studies in Hypospadias with a site in United States, this one is the 13th largest by enrollment of the 18 interventional ones that give a count, is the only one that started in 2015, is one of 14 with no phase, and was the 9th registered.
124 studies on the registry are indexed under Hypospadias; 35 are open to participants now.
Browse Hypospadias studies →4 of the 20 studies in Hypospadias with a site in United States are open now. Recruiting first, the newest first:
Sarah Schlegel · Sites in United States
Ages 18+ · Healthy volunteers
University of Wisconsin, Madison · Sites in United States
Ages 5–65 · Men only
University of North Carolina, Chapel Hill · Sites in United States
Boston Children's Hospital · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 20 Hypospadias studies recruiting now, 4 (20%) set no upper age limit and 16 (80%) stop at 75 or younger; 18 take children under 18; 3 take healthy volunteers.
This study: 3 Months to 6 Years · male · healthy volunteers too.
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20 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 48 is below the median of 70 across 98 interventional studies indexed under Hypospadias.
Median enrollment 67 across the 18 interventional studies, 237 across the 2 observational. Of the 13 that completed or were terminated, 4 (31%) have results posted.
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None of the 20 has an industry lead sponsor. The 10 most frequent:
Arkansas Children's Hospital Research Institute is the lead sponsor of 122 studies on the registry; 25 are open to participants now.
Arkansas Children's Hospital Research Institute has 1 study filed under Hypospadias — fewer than ten, so there is no comparison to draw.
2 of the studies in Hypospadias with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06966375University of Wisconsin, MadisonWorldwide Yearly Screening for Hypospadias | 2026-11 |
| NCT06989593Sarah SchlegelBreaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions | 2026-11 |
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Among the 20 studies in Hypospadias with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Hypospadias is a common condition where the opening of the penis is not located at the tip, but along the underside of the penis. It is estimated to occur in 1/300 live male births, making it one of the most common birth defects. Degrees of hypospadias ranged from minor to severe depending on the location of the opening. Surgical repair is often required and involves placement of a catheter for the urine to drain with known urinary colonization found on prior retrospective studies. The current practice of using preventative antibiotics as long as the catheter is in place is conflicting with resent studies that show antibiotics may not be necessary to prevent urinary tract infections (UTIs).
The purpose of this study was to see how common symptomatic UTIs were after hypospadias repair surgery; and to see whether routine antibiotic use after surgery affected the rate of UTIs. Subjects were randomized to either receive antibiotics or no antibiotics after distal hypospadias repair. The research coordinator made follow-up phone calls with the family and the primary care provider (PCP) after stent removal, 30 days post surgery and after the 3 month post surgical visit.
Males undergoing distal hypospadias repair involving stent placement were randomized to either receive or not to receive antibiotics post-operative. All subjects did not receive intra-operative antibiotics. Routine follow-up included having the stent removed one week post-op and a return visit at 3 months. The research nurse made follow-up phone calls to the family or the (PCP) one week after the stent was removed and at one month post-op to see how things were going with the child and again after teh 3 month post surgical visit, if the subject did not return after multiple rescheduling attempts.
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Exclusion Criteria:
Subjects were prescribed prophylactic antibiotics after the hypospadias surgery.
Other: Randomization to receive prophylactic antibiotics after surgery
Subjects were not prescribed prophylactic antibiotics after the hypospadias surgery.
Other: Randomization to not receive prophylactic antibiotics after surgery.
No antibiotics were ordered after surgery.
In general, the antibiotic given is a combination sulfamethoxazole/ trimethoprim oral suspension (2-3 mg trimethoprim/kg by mouth once a day); or if indicated, nitrofurantoin (1mg/kg by mouth once daily). All subjects did not receive intraoperative antibiotics.
Prevalence of symptomatic UTI within 30 days post-surgery
Assess the prevalence of symptomatic UTI in subjects receiving standard of care dispensation of prophylaxis versus subjects selected to an antibiotic-sparing cohort.
Time frame: 30 days post surgery
Evaluation of surgical site infections (SSIs) and complications of hypospadias repair
Surgical site infections (SSIs) are measured using physical assessments at the stent removal visit. Complications of hypospadias repair (urethral fistula, meatal stenosis, dehiscence, and diverticulum) are measured using physical assessments at the stent removal visit and/or contact with the family or the PCP office 1 week after the stent removal; at the 30 day post operative time point; and at the 3 month follow-op visit.
Time frame: Approximately post surgery: 2 weeks (stent is in approximately 1 week and then 1 week after the stent is removed); 30 days; and 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2015 to primary completion in Feb 2017, 24 months.
Of 60 non-industry interventional studies with no phase under Hypospadias, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 39. This study's 24 months is above that.
Counting every sponsor, half of 60 studies reached it within 15 months; a quarter within 8 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Arkansas Children's Hospital Research Institute →