Optimization of Spontaneous Postoperative Trial of Void Among Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimization of Spontaneous Trial of Void: a Prospective Cohort Study

Conditions
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Urinary Retention Postoperative, Voiding Disorders

Intervention / Treatment
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* Procedure: PVR-based self-catheterization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects will be taught to perform self-catheterization prior to prolapse repair or incontinence surgery; voiding data will be collected on the participant's first void after surgery. Participants will be discharged home to perform self-catheterization until post-void residual is less than half the volume voided on 2 sequential voids to assess actual voiding function, and this data will be used to calculate the diagnostic accuracy of pre-determined combinations of the TOV parameters.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PVR-based home self-catheterization<br>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. | Procedure: PVR-based self-catheterization<br>* Home self-catheterization based on standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-operative urinary retention | Based on defined criteria | 24-72 hours postoperative | 
| Diagnostic accuracy of trial of void parameters | 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. | First void postoperative (within 4 hours postop) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urogynecologic surgery, Urinary retention postoperative