Early Versus Late Voiding Trials After Prolapse Repair

Not Applicable

Terminated

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
voiding trial 4 hours post-op	Retrograde voiding trial	-
voiding trial post-op day 1	Retrograde voiding trial	-

Primary Outcome Measures

Name	Time	Method
time to return of normal bladder function	5 days

Secondary Outcome Measures

Name	Time	Method
time to first ambulation	24 hours
patient preference in the timing of the voiding trial	24 hours	a brief survey will be given 4 times during the hospital admission assess this
anxiety level	24 hours	The State-Trait Anxiety Index anxiety inventory will be administered pre-operatively and at 4 different time point post-operatively to assess the patient's level of anxiety related to the catheter
pain level	24 hours	A pain scale will be administered pre-operatively and at 4 different time point post-operatively to assess the patient's level of anxiety related to the catheter
catheter associated urinary tract infections	6 weeks	medical records will be reviewed after discharge from the hospital for positive urine cultures

Locations (1): Magee Women's Hospital of UPMC
🇺🇸
Pittsburgh, Pennsylvania, United States

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