Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery

Study Overview
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Brief Summary
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Urinary retention can lead to bladder over-distention, ischemia, and long-term voiding dysfunction, and early identification of urinary retention can help prevent these adverse events

Detailed Description
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Postoperative voiding trials (VT) can identify as well as prevent postoperative urinary retention. Voiding trial protocols vary by provider and healthcare facilities/institutions as there is no consensus on how to prevent postoperative urinary retention optimally. Identification of an optimal VT could not only help decrease adverse events associated with urinary retention but also decrease postoperative catheter-associated urinary tract infection (CAUTI) rates, unplanned hospital or clinic visits, and decrease patient discomfort while increasing patient satisfaction.

Official Title
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A Randomized Controlled Single-Blinded Study Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery

Conditions
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Voiding Dysfunction

Intervention / Treatment
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* Procedure: Control Group
* Procedure: Test Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nonpregnant women >18yo undergoing pelvic organ prolapse or urinary incontinence surgery Exclusion Criteria: Patients undergoing fistula repair or sacral neuromodulation Voiding dysfunction preoperatively that requires intermittent self-catheterization History of Neuromuscular Disorder History of Recurrent Urinary Tract Infections (UTIs) Intraoperative bladder injury Pregnancy Participant who could not tolerate at least 150cc backfilled

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be recruited at an Urogynecology office either at the pre-operative visit or on the day of surgery
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control group (voids 2/3 of the volume backfilled)<br>control group | Procedure: Control Group<br>* Patients will be randomized to a 200mL (control group)<br>* Other names: backfill-assisted voiding trial;|
| Active Comparator: test group (voids ½ of the total volume backfilled)<br>test group) | Procedure: Test Group<br>* Patients will be randomized to a cut-off of 150mL (test group)<br>* Other names: backfill-assisted voiding trial;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in acute voiding dysfunction between a backfill assisted voiding trial | difference in acute voiding dysfunction between a backfill assisted voiding trial with a volume voided cutoff of 150mL vs. 200mL for passage of VT - Acute voiding dysfunction is defined as a failed voiding trial requiring discharge home with a catheter, as well as voiding dysfunction occurring at a later time that results in an emergency department/urgent care/clinic visit requiring either an indwelling catheter or clean intermittent catheterization (CIC) | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients develops postoperative UTIs | UTI diagnosed by symptomatology alone or urinalysis (UA) + culture proven within one week (7 days) of catheter removal | Day 7 | 
| proportion of patients developing overactive bladder symptoms | Sudden urge to urinate that is difficult to hold, with leakage of urine (even if you just voided recently), Frequent urination (>8 times/day), or waking up at night to urinate (2 or more times/night) | Week 6 | 
| proportion of patients developing bladder pain or pressure | Bladder pain (pain or discomfort in the lower abdomen when your bladder is full) or bladder pressure (continuous feeling of pressure, not relieved by urination) | Week 6 | 
| proportion of patients requiring repeat outpatient voiding trials | proportion of patients requiring repeat outpatient voiding trials | Week 6 | 
| average number of days postoperatively, that require catheterization | average number of days postoperatively, that require catheterization | Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Tract Infections, overactive bladder, pelvic organ prolapse surgery, urinary incontinence surgery