Postoperative Care, Urinary Catheters, Urogynecology
Conditions
Brief summary
The goal of this clinical trial is to learn about active void trial pass rates in patients undergoing urogynecologic surgery. The main question it aims to answer is the comparison in pass rate during active void trial between women who are given 30 minutes versus 60 minutes to void following urogynecologic surgery. Patient will be randomized to two arms prior to scheduled surgery. During the active void trial, women will be allotted up to 30 minutes or up to 60 minutes to void depending on respective randomization.
Interventions
OTHERTime
Patients will be given up to 30 minutes to void.
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women undergoing a urogynecologic surgery at Tampa General Hospital and who are seen preoperatively at the University of South Florid Urogynecology clinic * Women undergoing a urogynecologic surgery where a postoperative active void trial is indicated * Planned for same day surgery * Women able to consent for themselves * Speak English and/or Spanish as preferred language
Exclusion criteria
* Imprisoned patients * Females under the age of 18 years old * Women who are unable or unwilling to consent to participation * Women who are planning to stay inpatient overnight * Women with history of urinary retention or neurogenic bladder * Women undergoing procedure that is not standard of care to perform a void trial (includes sacral neuromodulation, botox to the pelvic floor, cystoscopy with hydrodistension, urethral bulking, etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pass Rate | 60 minutes | to compare the active void trial pass rate between arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in PACU | 6 hours | to compare overall time spent in the PACU between arms |
| Pass Rate After Failing | 60 minutes | to assess the overall pass rate of active void trial after failed first attempt |
| UTI | 2 weeks | to assess rate of urinary tract infection after surgery |
| Surgical Procedures Performed Prior to Active Void Trial | 2 years | to compare types of surgery women are having with the rate of void trial passing |
Countries
United States
Outcome results
None listed