NCT03028753

Brief Summary

The investigators are trying to determine if using a bladder scanner (type of ultrasound) to check how much urine is left in the bladder is the same as checking that volume with a catheter (tube that goes into your bladder to drain urine). After urogynecologic surgery, the investigators perform a voiding trial. Water is put into the participant's bladder through the catheter (tube draining your bladder). The catheter is then removed and the participant is asked to empty their bladder. After that, the investigators will use the bladder scanner (ultrasound) to see how much urine is left in the participant's bladder. After the ultrasound, the investigators will pass a very small catheter (tube) into the bladder to take out the remaining urine. The investigators will then compare the amount obtained from the catheter to the ultrasound amount. This will also help the investigators to figure out if they need to check how much urine is left in a patient's bladder after the voiding trial.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

August 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

January 11, 2017

Last Update Submit

March 5, 2020

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

  • Determine if bladder scanners are accurate in determining a post void residual after urogynecologic surgery

    Within 48 hours after surgery

Secondary Outcomes (1)

  • Determine if a post void residual volume measurement is needed after a back-fill voiding trial after urogynecologic surgery

    Within 48 hours after surgery

Study Arms (1)

All subjects

EXPERIMENTAL

All subjects enrolled in the study will have a back-fill voiding trial performed at the time of catheter removal after urogynecologic surgery.

Device: Bladder scan post void residualProcedure: Straight catheter post void residualProcedure: Back fill voiding trial

Interventions

Bladder scan post void residualDEVICE

After voiding on the commode, all subjects will have a post void residual measured by bladder scanner

Also known as: Verathon BVI9400 Bladder scanner
All subjects
Straight catheter post void residualPROCEDURE

After voiding on the commode and having a post void residual measured by bladder scanner, all subjects will have a post void residual measured by straight catheter performed with usual sterile technique.

All subjects
Back fill voiding trialPROCEDURE

Prior to catheter removal, all subjects will undergo a back fill voiding trial. The bag of the foley catheter will be removed and the subjects bladder will be filled with 300cc of normal saline (or as much as they can tolerate). The foley catheter will then be removed and the subject will be asked to void on the commode. The voided volume will be measured.

All subjects

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing Urogynecologic surgery
  • Able to consent
  • Greater than 18 years old
  • Non pregnant

You may not qualify if:

  • Need for prolonged catheterization
  • Unable to consent
  • Prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Study Officials

  • Tanaz Ferzandi, MD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 23, 2017

Study Start

August 1, 2016

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations

US(1)