Voiding Dysfunction
Conditions
Keywords
Urinary Tract Infections, overactive bladder, pelvic organ prolapse surgery, urinary incontinence surgery
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
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.
Interventions
PROCEDUREControl Group
Patients will be randomized to a 200mL (control group)
PROCEDURETest Group
Patients will be randomized to a cut-off of 150mL (test group)
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The voiding trial instructions for each specific patient will be given to the Post Anesthesia Care Unit (P(ACU) or floor Registered Nurse (RN) taking care of the patient and will include what volume voided equals a passing voiding trial.
Intervention model description
Patients will be recruited at an Urogynecology office either at the pre-operative visit or on the day of surgery
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Nonpregnant women \>18yo undergoing pelvic organ prolapse or urinary incontinence surgery
Exclusion criteria
* Patients undergoing fistula repair or sacral neuromodulation * Voiding dysfunction preoperatively that requires intermittent self-catheterization * Intraoperative bladder injury * Pregnancy * Preoperative UTI (culture proven within 7 days prior to surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed