Optimization of Spontaneous Postoperative Trial of Void Among Women

Status unconfirmed · Not applicable

Conditions studied: Urinary Retention Postoperative, Voiding Disorders

In brief

Trial of void (TOV) is a diagnostic test performed on all women who undergo prolapse repair or incontinence surgery, due to the importance of diagnosing postoperative urinary retention (POUR). Incidence of POUR may be as high as 62% in some studies. Timely and accurate diagnosis is important to avoid complications such as urinary tract infection, bladder overdistension, and permanent bladder injury. Despite the frequent use of TOV, there is no gold standard for the test, and it likely has poor specificity, leading to discharge of more patients with catheter than required. This prospective cohort study will seek to establish evidence-based optimal parameters for spontaneous trial of void, a TOV modality that has merit for further evaluation given lower theoretical risk of urinary tract infection.

Key facts

Study ID

NCT04010656

Run by

Women and Infants Hospital of Rhode Island

People needed

183

Starts

2018-09-10

Expected to finish

2021-12-30

Last updated by the study team

2021-07-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• English-speaking women, age >18yo
• Scheduled for urogynecology procedure which will need post-operative trial of void (including pelvic organ prolapse and/or stress urinary incontinence repair), with plan for same-day discharge.

You may not qualify if…

• Unable or unwilling to perform self-catheterizatoin either by patient or willing family member
• Pre-existing voiding dysfunction defined as documented PVR > 200 mL
• Intraoperative urinary tract injury needing indwelling catheter on discharge
• Need for overnight admission

Where it is running

• Women & Infants Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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