Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery
Study Details
Study Description
Brief Summary
Urinary retention can lead to bladder over-distention, ischemia, and long-term voiding dysfunction, and early identification of urinary retention can help prevent these adverse events
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Postoperative voiding trials (VT) can identify as well as prevent postoperative urinary retention. Voiding trial protocols vary by provider and healthcare facilities/institutions as there is no consensus on how to prevent postoperative urinary retention optimally. Identification of an optimal VT could not only help decrease adverse events associated with urinary retention but also decrease postoperative catheter-associated urinary tract infection (CAUTI) rates, unplanned hospital or clinic visits, and decrease patient discomfort while increasing patient satisfaction.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: control group (voids 2/3 of the volume backfilled) control group |
Procedure: Control Group
Patients will be randomized to a 200mL (control group)
Other Names:
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| Active Comparator: test group (voids ½ of the total volume backfilled) test group) |
Procedure: Test Group
Patients will be randomized to a cut-off of 150mL (test group)
Other Names:
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Outcome Measures
Primary Outcome Measures
- difference in acute voiding dysfunction between a backfill assisted voiding trial [Week 6]
difference in acute voiding dysfunction between a backfill assisted voiding trial with a volume voided cutoff of 150mL vs. 200mL for passage of VT - Acute voiding dysfunction is defined as a failed voiding trial requiring discharge home with a catheter, as well as voiding dysfunction occurring at a later time that results in an emergency department/urgent care/clinic visit requiring either an indwelling catheter or clean intermittent catheterization (CIC)
Secondary Outcome Measures
- proportion of patients develops postoperative UTIs [Day 7]
UTI diagnosed by symptomatology alone or urinalysis (UA) + culture proven within one week (7 days) of catheter removal
- proportion of patients developing overactive bladder symptoms [Week 6]
Sudden urge to urinate that is difficult to hold, with leakage of urine (even if you just voided recently), Frequent urination (>8 times/day), or waking up at night to urinate (2 or more times/night)
- proportion of patients developing bladder pain or pressure [Week 6]
Bladder pain (pain or discomfort in the lower abdomen when your bladder is full) or bladder pressure (continuous feeling of pressure, not relieved by urination)
- proportion of patients requiring repeat outpatient voiding trials [Week 6]
proportion of patients requiring repeat outpatient voiding trials
- average number of days postoperatively, that require catheterization [Week 6]
average number of days postoperatively, that require catheterization
Eligibility Criteria
Criteria
Inclusion Criteria:
- Nonpregnant women >18yo undergoing pelvic organ prolapse or urinary incontinence surgery
Exclusion Criteria:
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Patients undergoing fistula repair or sacral neuromodulation
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Voiding dysfunction preoperatively that requires intermittent self-catheterization
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History of Neuromuscular Disorder
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History of Recurrent Urinary Tract Infections (UTIs)
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Intraoperative bladder injury
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Pregnancy
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Participant who could not tolerate at least 150cc backfilled
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: David Lovejoy, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00091698