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

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

Voiding Dysfunction

Treatments

Procedure: Control Group
Procedure: Test Group

Study type

Interventional

Funder types

Other

Identifiers

NCT05820139
IRB00091698

Details and patient eligibility

About

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

Full description

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.

Enrollment

100 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

control group (voids 2/3 of the volume backfilled)
Other group
Description:
control group
Treatment:
Procedure: Control Group
test group (voids ½ of the total volume backfilled)
Active Comparator group
Description:
test group)
Treatment:
Procedure: Test Group

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Bryar Thompson, DO

Data sourced from clinicaltrials.gov

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