Pelvic Organ Prolapse, Urinary Retention
Conditions
Keywords
voiding trial, pelvic organ prolapse, post-operative catheterization
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.
Interventions
PROCEDURERetrograde voiding trial
A bladder test is performed after surgery for prolapse to make sure the patient can empty their bladder prior to discharge from the hospital. The test consists of filling the bladder with 300 mL of water and removing the catheter. Then the patient voids.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to return of normal bladder function | 5 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to first ambulation | 24 hours | — |
| 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 |
| 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 |
| catheter associated urinary tract infections | 6 weeks | medical records will be reviewed after discharge from the hospital for positive urine cultures |
Countries
United States
Outcome results
None listed