NCT03646136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

August 7, 2018

Last Update Submit

January 28, 2020

Conditions

Urinary Retention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Foley catheter insertion rate

    2 weeks

  • Length of recovery room stay

    From time of randomization up to 12 hours postoperative

  • 4-Item Patient Satisfaction Measure

    12 hours

  • 2-Item Patient Satisfaction Measure

    24 hours

  • 3-Item Bladder Symptoms Measure

    24 hours

  • +2 more secondary outcomes

Study Arms (2)

Retained Cystoscopy Fluid

EXPERIMENTAL

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

Procedure: Retained fluid

Cystoscopy Fluid Emptied

ACTIVE COMPARATOR

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

Procedure: Emptied fluid

Interventions

Retained fluidPROCEDURE

Retained fluid

Retained Cystoscopy Fluid
Emptied fluidPROCEDURE

Emptied fluid

Cystoscopy Fluid Emptied

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen undergoing minimally invasive hysterectomy.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Related Publications (2)

  • 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.

    PMID: 34184246DERIVED

  • 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.

    PMID: 32505857DERIVED

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Rachael Smith, DO

    UofA College of Medicine Dept of OBG/Banner University Medical Center Phoenix

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
PACU nurses and patients will not be aware of which arm patient was randomized to.
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Rachael Smith, Principal Investigator

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 24, 2018

Study Start

October 10, 2018

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)