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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group (voids 2/3 of the volume backfilled) | Other | control group |
|
| test group (voids ½ of the total volume backfilled) | Active Comparator | test group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Group | Procedure | Patients will be randomized to a 200mL (control group) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
pelvic organ prolapse or urinary incontinence
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| Name | Affiliation | Role |
|---|---|---|
| David Lovejoy, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 7, 2023 | Apr 25, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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Patients will be recruited at an Urogynecology office either at the pre-operative visit or on the day of surgery
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The voiding trial instructions for each specific patient will be given to the Post Anesthesia Care Unit (P(ACU) or floor Registered Nurse (RN) taking care of the patient and will include what volume voided equals a passing voiding trial.
| Test Group | Procedure | Patients will be randomized to a cut-off of 150mL (test group) |
|
|
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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |