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Timing of Active Void Trials After Urogynecologic Procedures

University of South Florida logo

University of South Florida

Status

Completed

Conditions

Urogynecology
Urinary Catheters
Postoperative Care

Treatments

Other: Time

Study type

Interventional

Funder types

Other

Identifiers

NCT05885958
STUDY005629

Details and patient eligibility

About

The goal of this clinical trial is to learn about active void trial pass rates in patients undergoing urogynecologic surgery. The main question it aims to answer is the comparison in pass rate during active void trial between women who are given 30 minutes versus 60 minutes to void following urogynecologic surgery.

Patient will be randomized to two arms prior to scheduled surgery. During the active void trial, women will be allotted up to 30 minutes or up to 60 minutes to void depending on respective randomization.

Enrollment

231 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women undergoing a urogynecologic surgery at Tampa General Hospital and who are seen preoperatively at the University of South Florid Urogynecology clinic
  • Women undergoing a urogynecologic surgery where a postoperative active void trial is indicated
  • Planned for same day surgery
  • Women able to consent for themselves
  • Speak English and/or Spanish as preferred language

Exclusion criteria

  • Imprisoned patients
  • Females under the age of 18 years old
  • Women who are unable or unwilling to consent to participation
  • Women who are planning to stay inpatient overnight
  • Women with history of urinary retention or neurogenic bladder
  • Women undergoing procedure that is not standard of care to perform a void trial (includes sacral neuromodulation, botox to the pelvic floor, cystoscopy with hydrodistension, urethral bulking, etc)

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

231 participants in 2 patient groups

Immediate
Experimental group
Description:
Patients will be given up to 30 minutes to void during the active void trial postoperatively.
Treatment:
Other: Time
Other: Time
Extended
Experimental group
Description:
Patients will be given up to 60 minutes to void during the active void trial postoperatively.
Treatment:
Other: Time
Other: Time

Trial contacts and locations

1

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Central trial contact

Simone Fertel, MD

Data sourced from clinicaltrials.gov

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