Reducing Postoperative Catheterization
NCT03009968 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2018-03-19
Summary
After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with acute retention experience urinary tract infections in the postoperative period (6, 7). Many women consider being discharged with a Foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery(8). At this time there is no consensus within the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) on how to best assess voiding function postoperatively. FPMRS providers both within the United States and around the world utilize a variety of void trial methods and varying criteria to determine adequacy of post-operative voiding efficiency (5).
The traditional backfill assisted void trial method involves the assessment of a postvoid residual (PVR) volume obtained either via catheterization or bladder scan (3). Recently, there have been efforts to determine ways to avoid the assessment of a PVR as it is time-consuming and potentially exposes the patient to additional catheterizations (9, 10). Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead utilize a certain voided volume threshold to determine adequate voiding. However, to date, no one has directly studied this approach or compared the traditional backfill assisted void trial to a PVR-free backfill assisted void trial. By decreasing catheterization and creating a more efficient void trial method, the investigators hope improve patients' postoperative experience and reduce catheterization and risk of urinary tract infection (UTI).
This study aims to compare two void trial methodologies in order to help standardize post-operative care in the urogynecology population. This study also has potential to lead to an overall change in our field and improve the postoperative course for women across the country and abroad.
Conditions
- Urinary Retention
- Urinary Incontinence
- Pelvic Organ Prolapse
- Urinary Tract Infections
Interventions
- OTHER
-
Post-void residual free voiding trial
Will proceed with voiding trial and assess bladder emptying based on voided amount without checking a post-void residual.
Sponsors & Collaborators
-
North Carolina Translational and Clinical Sciences Institute
collaborator OTHER -
University of North Carolina, Chapel Hill
lead OTHER
Principal Investigators
-
Marcella G Willis-Gray, MD · UNC at Chapel Hill, Division of Female Pelvic Medicine and Reconstructive Surgery
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-03-17
- Primary Completion
- 2018-01-01
- Completion
- 2018-02-01
Countries
- United States
Study Locations
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