Reducing Postoperative Catheterization
Completed · Not applicable
Conditions studied: Urinary Retention, Urinary Incontinence, Pelvic Organ Prolapse, Urinary Tract Infections
In brief
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.
Key facts
- Study ID
- NCT03009968
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 150
- Starts
- 2017-03-17
- Expected to finish
- 2018-02-01
- Last updated by the study team
- 2018-03-19
Who can join
Age: 18 and older, up to 99. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- The study will include women scheduled for pelvic organ prolapse surgery and/or stress urinary incontinence surgery requiring a post-operative voiding trial.
- 18 years or older
- English speaking
- Documented PVR of less than 100mL prior to surgery obtained either during a previous clinic visit or at the time of their preoperative urodynamics evaluation.
You may not qualify if…
- Pregnancy
- Dependent on catheterization to void preoperatively
- Patient's undergoing fistula repair, sacral neuromodulation, urethral diverticulum/vaginal mass excision or mesh revision surgery
- Inability to give informed consent
Where it is running
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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