Post Hysterectomy Benefits of Retained Cystoscopy Fluid

Study Overview
=================
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.

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

Conditions
-----------------
Urinary Retention

Intervention / Treatment
-----------------
* Procedure: Retained fluid
* Procedure: Emptied fluid


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retained Cystoscopy Fluid<br>Retained 200mL normal saline used for distending media following completion of diagnostic cystoscopy | Procedure: Retained fluid<br>* Retained fluid<br>|
| Active Comparator: Cystoscopy Fluid Emptied<br>Emptied 200mL normal saline used for distending media following completion of diagnostic cystoscopy | Procedure: Emptied fluid<br>* Emptied fluid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |