NCT02277288

Brief Summary

The purpose of this randomized control trial study is to determine if intraoperative bladder instillation of fluid decreases the time to discharge after having an outpatient mid-urethral sling procedure, and to measure the cost savings of this decrease in hospital stay. Charges will be broken down between recovery room charges and discharge area, as recovery room charges are significantly higher. The investigators suspect that a shorter time in the recovery room will translate into fewer charges.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2011

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

14 years

First QC Date

October 16, 2014

Last Update Submit

July 17, 2018

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Time between surgery and discharge home

    Will analyze if the time to discharge is shorter in those patients who have had bladder instillation versus those with an indwelling catheter postoperatively.

    2 Days

Secondary Outcomes (1)

  • Hospital charges

    1 Month

Study Arms (2)

Emptied bladder arm

NO INTERVENTION

No instillation of fluid into bladder.

Filled bladder arm

EXPERIMENTAL

Instilled bladder with fluid.

Other: Filled bladder arm

Interventions

Filled bladder armOTHER

Bladder to be instilled with 200 cc fluid during cystoscopy and no catheter for all mid-urethral sling procedures.

Filled bladder arm

Eligibility Criteria

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

You may qualify if:

  • Female
  • Age 18 years or older
  • History of stress urinary incontinence
  • Scheduled for outpatient mid-urethral sling procedure, any approach

You may not qualify if:

  • Age less than 18 years
  • Pregnancy
  • Inability to give informed consent
  • History of urinary retention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Beverly Hills, California, 90211, United States

RECRUITING

Related Publications (5)

  • Boccola MA, Sharma A, Taylor C, Wong LM, Travis D, Chan S. The infusion method trial of void vs standard catheter removal in the outpatient setting: a prospective randomized trial. BJU Int. 2011 Apr;107 Suppl 3:43-6. doi: 10.1111/j.1464-410X.2011.10044.x.

    PMID: 21492377BACKGROUND

  • Wilson ID, Bramwell SP, Hollins GW. A randomized trial comparing bladder infusion with standard catheter removal after transurethral resection of the prostate. BJU Int. 2000 Dec;86(9):993-5. doi: 10.1046/j.1464-410x.2000.00963.x.

    PMID: 11119091BACKGROUND

  • McAchran SE, Goldman HB. Contemporary length of stay and resource utilization when using a fast-track regimen for mid-urethral sling surgery. Urology. 2009 Sep;74(3):531-4. doi: 10.1016/j.urology.2009.04.039. Epub 2009 Jul 9.

    PMID: 19592077BACKGROUND

  • Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S3-9.

    PMID: 16985863BACKGROUND

  • Wilson L, Brown JS, Shin GP, Luc KO, Subak LL. Annual direct cost of urinary incontinence. Obstet Gynecol. 2001 Sep;98(3):398-406. doi: 10.1016/s0029-7844(01)01464-8.

    PMID: 11530119BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Anger, MD, MPH

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Anger, MD, MPH

CONTACT

3103852992

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 16, 2014

First Posted

October 29, 2014

Study Start

December 1, 2011

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

US(1)