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Self-discontinuation of a Transurethral Catheter

Primary Purpose

Postoperative Urinary Retention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-removal
Sponsored by
TriHealth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Urinary Retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Undergoing vaginal vault suspension or robot-assisted laparoscopic sacrocolpopexy by a physician at Cincinnati Urogynecology Associates, TriHealth Inc.for the treatment of pelvic organ prolapse
  • Failed voiding trial prior to discharge
  • Concomitant procedures such as hysterectomy, suburethral sling, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy

Exclusion Criteria:

  • physical or mental impairment that would affect the subject's ability to self-remove indwelling urinary catheter, including patient's with Multiple Sclerosis, Dementia, Parkinsonism, or those who have impaired mobility or are wheelchair bound
  • Bladder injury, fistula repair or other need for prolonged catheterization

Sites / Locations

  • Cincinnati Urogynecology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-removal group

Office-removal group

Arm Description

The patients randomized to the self-removal group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.

The patients randomized to the office-removal group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.

Outcomes

Primary Outcome Measures

Number of Participants With Postoperative Urinary Retention
Number of Participants with postoperative urinary retention (POUR) following pelvic reconstructive surgery for pelvic organ prolapse. Pour at 1-week was defined as continued catheterization on POD 6-8

Secondary Outcome Measures

Full Information

First Posted
December 15, 2016
Last Updated
November 7, 2019
Sponsor
TriHealth Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02996968
Brief Title
Self-discontinuation of a Transurethral Catheter
Official Title
Is Self-discontinuation of a Transurethral Catheter Following Pelvic Reconstructive Surgery as Effective as Office-based Discontinuation?; A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
May 16, 2019 (Actual)
Study Completion Date
May 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to determine if self-discontinuation of transurethral foley catheters in patients diagnosed with postoperative urinary retention (POUR), which is defined as the continued need for catheterization, following impatient pelvic organ prolapse surgery is non-inferior to office-discontinuation.
Detailed Description
Postoperative urinary retention (POUR) is a common issue following urogynecologic surgery, with incidence rates of 1.4-43%. The wide range of incidence is due to the lack of a standardized definition of POUR. Generally speaking, POUR can be characterized by any impairment in bladder emptying following surgery. While the gold standard for assessing voiding function remains measurement of a postvoid residual (PVR), there are many voiding trial (VT) methods being used across institutions. Historically, the most widely accepted postoperative VT for the assessment of voiding function was the backfill method. An alternative assessment of voiding function is the spontaneous VT, where the indwelling catheter is removed and a patient is asked to void spontaneously when a patient has the urge. It is controversial which of these methods are superior, and studies are conflicted. Nevertheless, both of these methods were studied in a clinical setting, and we lack information on self-discontinuation efficacy at home. Managing an indwelling urinary catheter and returning to the outpatient clinic only a week after discharge from the hospital can be overwhelming for patients and their involved caregivers. Given the low incidence of POUR at one-week postoperative and patient dissatisfaction with urinary catheter management, home self-removal of indwelling urinary catheters is an important topic of investigation. We are trying to compare the incidence of POUR between self-discontinuation and office-discontinuation of urinary catheters. The results of this study could impact on the decision regarding catheter use following inpatient pelvic organ prolapse surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Urinary Retention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-removal group
Arm Type
Experimental
Arm Description
The patients randomized to the self-removal group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.
Arm Title
Office-removal group
Arm Type
No Intervention
Arm Description
The patients randomized to the office-removal group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.
Intervention Type
Procedure
Intervention Name(s)
Self-removal
Intervention Description
Self-discontinuation of a transurethral catheter
Primary Outcome Measure Information:
Title
Number of Participants With Postoperative Urinary Retention
Description
Number of Participants with postoperative urinary retention (POUR) following pelvic reconstructive surgery for pelvic organ prolapse. Pour at 1-week was defined as continued catheterization on POD 6-8
Time Frame
postoperative day 6-8

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing vaginal vault suspension or robot-assisted laparoscopic sacrocolpopexy by a physician at Cincinnati Urogynecology Associates, TriHealth Inc.for the treatment of pelvic organ prolapse Failed voiding trial prior to discharge Concomitant procedures such as hysterectomy, suburethral sling, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy Exclusion Criteria: physical or mental impairment that would affect the subject's ability to self-remove indwelling urinary catheter, including patient's with Multiple Sclerosis, Dementia, Parkinsonism, or those who have impaired mobility or are wheelchair bound Bladder injury, fistula repair or other need for prolonged catheterization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Pauls, MD
Organizational Affiliation
TriHealth - Cincinnati Urogynecology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Urogynecology Associates
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31599827
Citation
Shatkin-Margolis A, Yook E, Hill AM, Crisp CC, Yeung J, Kleeman S, Pauls RN. Self-Removal of a Urinary Catheter After Urogynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Nov;134(5):1027-1036. doi: 10.1097/AOG.0000000000003531.
Results Reference
derived

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Self-discontinuation of a Transurethral Catheter

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