Early Versus Late Voiding Trials After Prolapse Repair
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About
The primary aim of this study is to determine if normal bladder function (the ability to empty the bladder during spontaneous urination) after surgical repair of pelvic organ prolapse returns faster in patients who have a retrograde voiding trial the day of surgery versus patients who have a retrograde voiding trial on postoperative day one. Half of participants will have a voiding trial 4 hours after surgery, while the other half will have the voiding trial postoperative day one.
Full description
Overnight indwelling catheterization is a prevalent practice after surgical repair of pelvic organ prolapse. A voiding trial is performed postoperative day one to determine if urinary retention or abnormal bladder function exists. A significant number of patients ranging from 26-47% will require continued catheterization post-op for urinary retention in order to avoid injuries associated with over distention of the bladder and ureteral reflux.
This study aims to explore a strategy to reduce the length of catheterization post-operatively by testing the bladder at a closer interval to surgery. An earlier voiding trial may improve patient perioperative satisfaction and decrease catheter associated urinary tract infections. Additional benefits that may also be seen are earlier first ambulation and quicker achievement of post-op discharge milestones (pain control, ambulation with symptoms, oral intake tolerance and completion of a voiding trial). To date, few studies have attempted a day of surgery voiding trial in patients being admitted for repair of pelvic organ prolapse that requires an overnight admission.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- surgical management of pelvic organ prolapse requiring an overnight hospital admission
Exclusion criteria
- same day surgery
- non-ambulatory (allowed to use an assistive device)
- inability to provide informed consent, age < 21 years
- pregnancy or desire for future pregnancy
- systematic disease known to affect bladder function (Parkinson's disease, Multiple Sclerosis, Spina Bifida, spinal cord injury or trauma and neurogenic bladder)
- known preoperative urinary retention (defined as a post-void residual > 100mL)
- an untreated urinary tract infection at the time of surgery
- treatment at the time of surgery for urinary tract infection
- symptoms of urinary tract infection on the day of surgery
Trial design
Primary purpose
Allocation
Interventional model
Masking
57 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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