Post Hysterectomy Benefits of Retained Cystoscopy Fluid

Urinary Retention Clinical Trial

Official title:

Benefits of Retained Cystoscopy Fluid Following Benign Laparoscopic and Robotic Hysterectomy; A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646136
• Other study ID #: UA IRB# 1808885089
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: January 2020
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Retention

Intervention

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

Locations

Country	Name	City	State
United States	Banner University Medical Center Phoenix	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From surgery end time up to 4 hours
Secondary	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.	2 weeks
Secondary	Length of recovery room stay	Measure of time from surgery end time to discharge home from the recovery room post hysterectomy.	From time of randomization up to 12 hours postoperative
Secondary	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).	12 hours
Secondary	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).	24 hours
Secondary	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.	24 hours
Secondary	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).	12 hours
Secondary	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).	24 hours