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Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

NCT03048682 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-08-21

Study results available
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Summary

This study is a randomized controlled trial designed to assess the rate of failure of voiding trials in the early and late post-operative period within patients who underwent outpatient pelvic floor surgery that failed initial same day voiding trials.

Conditions

  • Pelvic Organ Prolapse
  • Urinary Incontinence,Stress
  • Surgery

Interventions

DEVICE

Foley catheter - Early Voiding Trial

All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial. Subjects in the Early Voiding group will have their repeat voiding trial on post-op day #2, 3, or 4 will undergo an in-office voiding trial. The experimental group will return for an in-office voiding trial sooner than the active comparator.

DEVICE

Foley catheter - Late Voiding Trial

All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial. Subjects in the Late Voiding group will have their repeat voiding trial on post-op day #7 or after. This is our current practice

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    collaborator OTHER

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Jeffrey Schachar, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-05
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03048682 on ClinicalTrials.gov