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Early Versus Late Voiding Trials After Prolapse Repair

Primary Purpose

Urinary Retention, Pelvic Organ Prolapse

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retrograde voiding trial
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Retention focused on measuring voiding trial, pelvic organ prolapse, post-operative catheterization

Eligibility Criteria

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

Inclusion Criteria:

  • surgical management of pelvic organ prolapse requiring an overnight hospital admission

Exclusion Criteria:

  • same day surgery
  • non-ambulatory (allowed to use an assistive device)
  • inability to provide informed consent, age < 21 years
  • pregnancy or desire for future pregnancy
  • systematic disease known to affect bladder function (Parkinson's disease, Multiple Sclerosis, Spina Bifida, spinal cord injury or trauma and neurogenic bladder)
  • known preoperative urinary retention (defined as a post-void residual > 100mL)
  • an untreated urinary tract infection at the time of surgery
  • treatment at the time of surgery for urinary tract infection
  • symptoms of urinary tract infection on the day of surgery

Sites / Locations

  • Magee Women's Hospital of UPMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

voiding trial 4 hours post-op

voiding trial post-op day 1

Arm Description

Outcomes

Primary Outcome Measures

time to return of normal bladder function

Secondary Outcome Measures

time to first ambulation
anxiety level
The State-Trait Anxiety Index anxiety inventory will be administered pre-operatively and at 4 different time point post-operatively to assess the patient's level of anxiety related to the catheter
pain level
A pain scale will be administered pre-operatively and at 4 different time point post-operatively to assess the patient's level of anxiety related to the catheter
patient preference in the timing of the voiding trial
a brief survey will be given 4 times during the hospital admission assess this
catheter associated urinary tract infections
medical records will be reviewed after discharge from the hospital for positive urine cultures

Full Information

First Posted
March 10, 2016
Last Updated
June 25, 2018
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02739256
Brief Title
Early Versus Late Voiding Trials After Prolapse Repair
Official Title
Normal Voiding Function After Surgical Repair of Pelvic Organ Prolapse: A Randomized Trial Comparing Day of Surgery Retrograde Void Trials to Standard Postoperative Day One Retrograde Void Trials
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Institutional implementation of a same day discharge pathway
Study Start Date
February 2016 (undefined)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of this study is to determine if normal bladder function (the ability to empty the bladder during spontaneous urination) after surgical repair of pelvic organ prolapse returns faster in patients who have a retrograde voiding trial the day of surgery versus patients who have a retrograde voiding trial on postoperative day one. Half of participants will have a voiding trial 4 hours after surgery, while the other half will have the voiding trial postoperative day one.
Detailed Description
Overnight indwelling catheterization is a prevalent practice after surgical repair of pelvic organ prolapse. A voiding trial is performed postoperative day one to determine if urinary retention or abnormal bladder function exists. A significant number of patients ranging from 26-47% will require continued catheterization post-op for urinary retention in order to avoid injuries associated with over distention of the bladder and ureteral reflux. This study aims to explore a strategy to reduce the length of catheterization post-operatively by testing the bladder at a closer interval to surgery. An earlier voiding trial may improve patient perioperative satisfaction and decrease catheter associated urinary tract infections. Additional benefits that may also be seen are earlier first ambulation and quicker achievement of post-op discharge milestones (pain control, ambulation with symptoms, oral intake tolerance and completion of a voiding trial). To date, few studies have attempted a day of surgery voiding trial in patients being admitted for repair of pelvic organ prolapse that requires an overnight admission.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Pelvic Organ Prolapse
Keywords
voiding trial, pelvic organ prolapse, post-operative catheterization

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
voiding trial 4 hours post-op
Arm Type
Experimental
Arm Title
voiding trial post-op day 1
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Retrograde voiding trial
Other Intervention Name(s)
Bladder Test
Intervention Description
A bladder test is performed after surgery for prolapse to make sure the patient can empty their bladder prior to discharge from the hospital. The test consists of filling the bladder with 300 mL of water and removing the catheter. Then the patient voids.
Primary Outcome Measure Information:
Title
time to return of normal bladder function
Time Frame
5 days
Secondary Outcome Measure Information:
Title
time to first ambulation
Time Frame
24 hours
Title
anxiety level
Description
The State-Trait Anxiety Index anxiety inventory will be administered pre-operatively and at 4 different time point post-operatively to assess the patient's level of anxiety related to the catheter
Time Frame
24 hours
Title
pain level
Description
A pain scale will be administered pre-operatively and at 4 different time point post-operatively to assess the patient's level of anxiety related to the catheter
Time Frame
24 hours
Title
patient preference in the timing of the voiding trial
Description
a brief survey will be given 4 times during the hospital admission assess this
Time Frame
24 hours
Title
catheter associated urinary tract infections
Description
medical records will be reviewed after discharge from the hospital for positive urine cultures
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: surgical management of pelvic organ prolapse requiring an overnight hospital admission Exclusion Criteria: same day surgery non-ambulatory (allowed to use an assistive device) inability to provide informed consent, age < 21 years pregnancy or desire for future pregnancy systematic disease known to affect bladder function (Parkinson's disease, Multiple Sclerosis, Spina Bifida, spinal cord injury or trauma and neurogenic bladder) known preoperative urinary retention (defined as a post-void residual > 100mL) an untreated urinary tract infection at the time of surgery treatment at the time of surgery for urinary tract infection symptoms of urinary tract infection on the day of surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charelle Carter-Brooks, MD
Organizational Affiliation
Urogynecology Fellow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee Women's Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22752014
Citation
Oliphant SS, Lowder JL, Ghetti C, Zyczynski HM. Effect of a preoperative self-catheterization video on anxiety: a randomized controlled trial. Int Urogynecol J. 2013 Mar;24(3):419-24. doi: 10.1007/s00192-012-1868-y. Epub 2012 Jul 3.
Results Reference
result
PubMed Identifier
21860294
Citation
Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.
Results Reference
result
PubMed Identifier
25185611
Citation
Turner LC, Kantartzis K, Shepherd JP. Predictors of postoperative acute urinary retention in women undergoing minimally invasive sacral colpopexy. Female Pelvic Med Reconstr Surg. 2015 Jan-Feb;21(1):39-42. doi: 10.1097/SPV.0000000000000110.
Results Reference
result
PubMed Identifier
34184246
Citation
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
Results Reference
derived

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Early Versus Late Voiding Trials After Prolapse Repair

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