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Post Hysterectomy Benefits of Retained Cystoscopy Fluid

Primary Purpose

Urinary Retention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retained fluid
Emptied fluid
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female patients, greater than or equal to 18 years old
  • English-speaking
  • Undergoing laparoscopic or robotic hysterectomy for benign indications by one of the three minimally invasive gynecologic surgeons at Banner University Medical Center - Phoenix.

Exclusion Criteria:

  • Preoperative indications of pelvic organ prolapse
  • Preoperative indications of urinary incontinence
  • Lower urologic (bladder or ureteric) injury identified at time of hysterectomy or during intraoperative cystoscopy
  • Patients given any measure to aid in visualization of ureteral patency including dextrose, phenazopyridine, indigo carmine, methylene blue, sodium fluorescein, or furosemide.

Sites / Locations

  • Banner University Medical Center Phoenix

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Retained Cystoscopy Fluid

Cystoscopy Fluid Emptied

Arm Description

Retained 200mL normal saline used for distending media following completion of diagnostic cystoscopy

Emptied 200mL normal saline used for distending media following completion of diagnostic cystoscopy

Outcomes

Primary Outcome Measures

Time to spontaneous void
Measure of time to spontaneous urination in the recovery room post hysterectomy. Time of urination is measured by the recovery room nurse from surgery end time.

Secondary Outcome Measures

Foley catheter insertion rate
Rate of patient's requiring Foley catheter insertion post hysterectomy if unable to spontaneously void in recovery room or anytime within 2 weeks postoperative.
Length of recovery room stay
Measure of time from surgery end time to discharge home from the recovery room post hysterectomy.
4-Item Patient Satisfaction Measure
Self reported patient satisfaction survey related to ability to urinate in the recovery room, amount of time given to urinate, amount of time it took to urinate, and overall bladder discomfort. Each item is scored 1-5 (1=very satisfied, 5=very dissatisfied).
2-Item Patient Satisfaction Measure
Self reported patient satisfaction survey related to voiding function over 24 hours and overall bladder discomfort over 24 hours. Each item is scored 1-5 (1=very satisfied, 5=very dissatisfied).
3-Item Bladder Symptoms Measure
Self reported bladder symptom measure of burning, frequency, and urgency with voiding over the 24 hours postoperative. Measured as Yes/No.
2-Item Bladder pain Measure
Self reported bladder pain intensity on initial arrival to the recovery room and at discharge from the recovery room. Each item is scored 1-10 (1=no discomfort, 10=most discomfort).
3-Item Bladder pain Measure
Self reported bladder pain intensity over 24 hours postoperative, bladder discomfort before urination, and bladder discomfort after urination. Each item is scored 1-10 (1=no discomfort, 10=most discomfort).

Full Information

First Posted
August 7, 2018
Last Updated
January 28, 2020
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT03646136
Brief Title
Post Hysterectomy Benefits of Retained Cystoscopy Fluid
Official Title
Benefits of Retained Cystoscopy Fluid Following Benign Laparoscopic and Robotic Hysterectomy; A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to compare outcomes for women in two study arms that include retaining the cystoscopy distending fluid after minimally invasive hysterectomy verses completely emptying the cystoscopy distending fluid. The outcomes being measured for research purposes include the time spent to first spontaneous urination after surgery, rate of indwelling catheter insertion, length of recovery room stay, the amount of bladder discomfort immediately postoperative and over the first 24 hours postoperative, bladder symptoms over the first 24 hours postoperative, and patient satisfaction.
Detailed Description
Acute urinary retention can be a common postoperative complication following hysterectomy. One of the many benefits of minimally invasive surgery is shorter hospital stay following a major procedure such as laparoscopic or robotic hysterectomy. An important postoperative milestone before discharge from the postoperative anesthesia care unit (PACU) is spontaneous voiding. If unable to spontaneously void due to urinary retention, insertion of an indwelling catheter may be required. Awaiting a spontaneous void in the recovery room can lead to longer hospital and PACU stays, greater cost, and patient dissatisfaction. At the conclusion of traditional laparoscopic or robotic-assisted hysterectomy, intraoperative cystoscopy is performed to evaluate for urologic injury. One possible strategy to more quickly facilitate a postoperative spontaneous void is to retain the cystoscopy distending fluid at conclusion of cystoscopy rather than emptying the bladder of the distending fluid. Although there is no published research investigating voiding time following laparoscopic or robotic hysterectomy using strategies such as backfilling the bladder before removal of the indwelling catheter or retaining the cystoscopy distending fluid following diagnostic cystoscopy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Care Provider
Masking Description
PACU nurses and patients will not be aware of which arm patient was randomized to.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retained Cystoscopy Fluid
Arm Type
Experimental
Arm Description
Retained 200mL normal saline used for distending media following completion of diagnostic cystoscopy
Arm Title
Cystoscopy Fluid Emptied
Arm Type
Active Comparator
Arm Description
Emptied 200mL normal saline used for distending media following completion of diagnostic cystoscopy
Intervention Type
Procedure
Intervention Name(s)
Retained fluid
Intervention Description
Retained fluid
Intervention Type
Procedure
Intervention Name(s)
Emptied fluid
Intervention Description
Emptied fluid
Primary Outcome Measure Information:
Title
Time to spontaneous void
Description
Measure of time to spontaneous urination in the recovery room post hysterectomy. Time of urination is measured by the recovery room nurse from surgery end time.
Time Frame
From surgery end time up to 4 hours
Secondary Outcome Measure Information:
Title
Foley catheter insertion rate
Description
Rate of patient's requiring Foley catheter insertion post hysterectomy if unable to spontaneously void in recovery room or anytime within 2 weeks postoperative.
Time Frame
2 weeks
Title
Length of recovery room stay
Description
Measure of time from surgery end time to discharge home from the recovery room post hysterectomy.
Time Frame
From time of randomization up to 12 hours postoperative
Title
4-Item Patient Satisfaction Measure
Description
Self reported patient satisfaction survey related to ability to urinate in the recovery room, amount of time given to urinate, amount of time it took to urinate, and overall bladder discomfort. Each item is scored 1-5 (1=very satisfied, 5=very dissatisfied).
Time Frame
12 hours
Title
2-Item Patient Satisfaction Measure
Description
Self reported patient satisfaction survey related to voiding function over 24 hours and overall bladder discomfort over 24 hours. Each item is scored 1-5 (1=very satisfied, 5=very dissatisfied).
Time Frame
24 hours
Title
3-Item Bladder Symptoms Measure
Description
Self reported bladder symptom measure of burning, frequency, and urgency with voiding over the 24 hours postoperative. Measured as Yes/No.
Time Frame
24 hours
Title
2-Item Bladder pain Measure
Description
Self reported bladder pain intensity on initial arrival to the recovery room and at discharge from the recovery room. Each item is scored 1-10 (1=no discomfort, 10=most discomfort).
Time Frame
12 hours
Title
3-Item Bladder pain Measure
Description
Self reported bladder pain intensity over 24 hours postoperative, bladder discomfort before urination, and bladder discomfort after urination. Each item is scored 1-10 (1=no discomfort, 10=most discomfort).
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women undergoing minimally invasive hysterectomy.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female patients, greater than or equal to 18 years old English-speaking Undergoing laparoscopic or robotic hysterectomy for benign indications by one of the three minimally invasive gynecologic surgeons at Banner University Medical Center - Phoenix. Exclusion Criteria: Preoperative indications of pelvic organ prolapse Preoperative indications of urinary incontinence Lower urologic (bladder or ureteric) injury identified at time of hysterectomy or during intraoperative cystoscopy Patients given any measure to aid in visualization of ureteral patency including dextrose, phenazopyridine, indigo carmine, methylene blue, sodium fluorescein, or furosemide.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachael Smith, DO
Organizational Affiliation
UofA College of Medicine Dept of OBG/Banner University Medical Center Phoenix
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner University Medical Center Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
PubMed Identifier
32505857
Citation
Smith RB, Mahnert ND, Hu C, Steck-Bayat K, Womack AS, Mourad J. Impact of Retained Cystoscopy Fluid after Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Feb;28(2):288-296. doi: 10.1016/j.jmig.2020.05.024. Epub 2020 Jun 4.
Results Reference
derived

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Post Hysterectomy Benefits of Retained Cystoscopy Fluid

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