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NCT02189291 · ClinicalTrials.gov registry record · NA

Study to Assess Duration of Indwelling Catheter After Sacrocolpopexy

A NA study, sponsored by Oregon Health and Science University.

Completed
Registry status
NA
Development phase
72
Enrollment target

NCT02189291 is a NA study that has completed, run by Oregon Health and Science University. The registered enrollment target is 72 participants.

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The verdict

NCT02189291, a NA study, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
NA
Development phase
72 participants
Enrollment target

Study Summary

Objectives The objective of this study is to help identify the best practice regarding the use of indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a randomized controlled trial comparing the immediate removal of indwelling urethral catheter, after minimally invasive sacrocolpopexy, to the present standard catheter removal on post operative day one. Evidence based catheter management will be helpful to both providers and patients in post-operative decision making. Specific Aims Aim 1: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy results in shorter hospital stay than removal on postoperative day 1. Aim 2: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy confers no increased risk of re-catheterization. Aim 3: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy decreases the occurrence of urinary tract infection. Design A randomized controlled trial comparing the standard overnight indwelling urethral catheterization with removal of catheter immediately post surgery after minimally invasive sacrocolpopexy, at Oregon Health \& Science University. Outcome measures Primary outcome measures are hospital stay in hours after completion of surgery and need for re-catheterization. Hospital stay will be counted from the time the patient leaves the operating room to the time she leaves the hospital. To avoid confounding, investigators are only including the first / morning case of the day. For re-catheterization, investigators will evaluate if patient was able to void after completion of surgery. Investigators will compare the post voiding residuals, the need for re-catheterizations and the numbers of patients going home with an indwelling catheter between the two groups. Investigators will also compare the number of urinary tract infections, as documented by urine culture and subsequent treatment, between t

Interventions

  • PROCEDURE Immediate catheter removal
  • PROCEDURE Post op day 1 catheter removal

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2014-07
Est. Completion 2018-12-31
Phase NA

What the Registry Record Tells You About NCT02189291

The ClinicalTrials.gov registry entry for NCT02189291 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Immediate catheter removal is the first listed.

NCT02189291 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02189291 about?

NCT02189291 is a clinical study titled "Study to Assess Duration of Indwelling Catheter After Sacrocolpopexy". Objectives The objective of this study is to help identify the best practice regarding the use of indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a randomized controlled trial comparing the immediate removal of indwelling urethral catheter, after minimally...

What is the current status of trial NCT02189291?

This trial is currently completed. It is a NA study. The enrollment target is 72 participants. The study started on 2014-07. Estimated completion is 2018-12-31.

What interventions are being tested in trial NCT02189291?

The interventions under investigation include: Immediate catheter removal (PROCEDURE), Post op day 1 catheter removal (PROCEDURE).

Who is sponsoring clinical trial NCT02189291?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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