Optimization of Spontaneous Postoperative Trial of Void Among Women

Not Applicable

• Conditions: Urinary Retention Postoperative; Voiding Disorders
• Interventions: Procedure: PVR-based self-catheterization

• Registration Number: NCT04010656
• Lead Sponsor: Women and Infants Hospital of Rhode Island

Brief Summary

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.

Detailed Description

Patients will learn to perform self-catheterization ('clean intermittent catheterization', or CIC) preoperatively; after surgery, the investigators will collect a range of voiding parameters used during different TOV protocols (including minimum voided volume \[MVV\], post-void residual via bladder scanner \[PVR\], subjective force of urinary stream \[sFOS\]). Patients will discharge home to perform CIC until two sequential post-void residuals of less than half the volume voided have been achieved. The rate of voiding dysfunction and resulting PVRs will be used to compare the diagnostic accuracy of the perioperative voiding parameters to predict need to perform CIC and post-operative urinary retention.

Study Timeline

• Study Start: 2018-09-10
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-08
• Primary Completion: 2021-05-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-20
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 183

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PVR-based home self-catheterization	PVR-based self-catheterization	Patients will learn to self-catheterize preoperatively prior to urogynecology surgery requiring trial of void. First post-operative void will be used to collect basic information about voiding function. All participants will leave the hospital and self-catheterize until they achieve two sequential voids with post-void residual (PVR) less than half the volume voided. The cases of urinary retention captured with abnormal PVR will be used to compare the diagnostic accuracy of several commonly-used, pre-defined parameters for trial of void.

Primary Outcome Measures

Name	Time	Method
Incidence of post-operative urinary retention	24-72 hours postoperative	Based on defined criteria
Diagnostic accuracy of trial of void parameters	First void postoperative (within 4 hours postop)	Comparison of sensitivity, specificity, positive/negative predictive value of different trial of void parameters from first postoperative void, based on those used in the literature.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with self-catheterization method via questionnaire	2 weeks postoperative	Novel questionnaire, 5 point Likert scale from "Very dissatisfied to Very satisfied"
Time to first void postoperative	4 hours postoperative	To assess time to spontaneous void after surgery
Rate of post-operative and post-discharge urinary retention	24-72 hours postoperative	Based on post-void residual volume
Rate of post-operative urinary tract infection	6 weeks postoperative	UTI in first 6 weeks postoperative

Trial Locations

Locations (1)

Women & Infants Hospital; 🇺🇸 Providence, Rhode Island, United States