Post Hysterectomy Benefits of Retained Cystoscopy Fluid

• ClinicalTrials.gov Identifier: NCT03646136
• Recruitment Status: Completed
• First Posted: August 24, 2018
• Last Update Posted: January 29, 2020
• Sponsor: University of Arizona
• Information provided by (Responsible Party): Rachael Bailey Smith, University of Arizona

Tracking Information

• First Submitted Date: August 7, 2018
• First Posted Date: August 24, 2018
• Last Update Posted Date: January 29, 2020
• Actual Study Start Date: October 10, 2018
• Actual Primary Completion Date: October 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 22, 2018)

Time to spontaneous void [ Time Frame: From surgery end time up to 4 hours ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 22, 2018)

• Foley catheter insertion rate [ Time Frame: 2 weeks ]
  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 [ Time Frame: From time of randomization up to 12 hours postoperative ]
  Measure of time from surgery end time to discharge home from the recovery room post hysterectomy.
• 4-Item Patient Satisfaction Measure [ Time Frame: 12 hours ]
  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 [ Time Frame: 24 hours ]
  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 [ Time Frame: 24 hours ]
  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 [ Time Frame: 12 hours ]
  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 [ Time Frame: 24 hours ]
  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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Care Provider)
Masking Description:

PACU nurses and patients will not be aware of which arm patient was randomized to.

Primary Purpose: Other

• Condition: Urinary Retention

Intervention

• Procedure: Retained fluid
  Retained fluid
• Procedure: Emptied fluid
  Emptied fluid

Study Arms

• Experimental: Retained Cystoscopy Fluid
  Retained 200mL normal saline used for distending media following completion of diagnostic cystoscopy
  Intervention: Procedure: Retained fluid
• Active Comparator: Cystoscopy Fluid Emptied
  Emptied 200mL normal saline used for distending media following completion of diagnostic cystoscopy
  Intervention: Procedure: Emptied fluid

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 9, 2019): 120
• Original Estimated Enrollment (submitted: August 22, 2018): 60
• Actual Study Completion Date: October 30, 2019
• Actual Primary Completion Date: October 30, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Women undergoing minimally invasive hysterectomy.

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03646136
• Other Study ID Numbers: UA IRB# 1808885089
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Rachael Bailey Smith, University of Arizona
• Study Sponsor: University of Arizona
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rachael Smith, DO; UofA College of Medicine Dept of OBG/Banner University Medical Center Phoenix

• PRS Account: University of Arizona
• Verification Date: January 2020