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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-11

Study Completion Date

2024-02-26

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

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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.

Conditions

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Voiding Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be recruited at an Urogynecology office either at the pre-operative visit or on the day of surgery

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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control group (voids 2/3 of the volume backfilled)

control group

Group Type OTHER

Control Group

Intervention Type PROCEDURE

Patients will be randomized to a 200mL (control group)

test group (voids ½ of the total volume backfilled)

test group)

Group Type ACTIVE_COMPARATOR

Test Group

Intervention Type PROCEDURE

Patients will be randomized to a cut-off of 150mL (test group)

Interventions

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Control Group

Patients will be randomized to a 200mL (control group)

Intervention Type PROCEDURE

Test Group

Patients will be randomized to a cut-off of 150mL (test group)

Intervention Type PROCEDURE

Other Intervention Names

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backfill-assisted voiding trial backfill-assisted voiding trial

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
* Intraoperative bladder injury
* Pregnancy
* Preoperative UTI (culture proven within 7 days prior to surgery)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No