NCT01583166

Brief Summary

The purpose of this study is to determine if there is a difference in post-operative voiding function between subjects receiving local anesthetic and those receiving placebo at the time of mid-urethral sling placement. The secondary objective is to evaluate pain after the procedure in the two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

November 28, 2018

Completed
Last Updated

November 28, 2018

Status Verified

October 1, 2018

Enrollment Period

4.2 years

First QC Date

April 19, 2012

Results QC Date

May 2, 2018

Last Update Submit

October 29, 2018

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling

    Study team assessment of whether the use of local anesthetic has any affect on the percentage of patients who pass their post-operative bladder challenge. This is determined by their voided volume and post-void residual.

    2 weeks

Secondary Outcomes (3)

  • Post-operative Pain Scores at 2-3 Hours Post op

    2-3 hours

  • Post-operative Pain Scale at 6-7 Hours Post op

    6-7 hours

  • Visual Analog Scale for Pain: Pre-operative.

    At enrollment

Study Arms (2)

Bupivacaine + epinephrine

ACTIVE COMPARATOR
Drug: BupivacaineDrug: Epinephrine

Saline + epinephrine

PLACEBO COMPARATOR
Drug: Saline

Interventions

BupivacaineDRUG

10ml 0.5% bupivacaine

Also known as: Marcaine
Bupivacaine + epinephrine
SalineDRUG

10ml 0.9% sodium chloride

Also known as: Sodium Chloride
Saline + epinephrine
EpinephrineDRUG

1:200,000 epinephrine

Bupivacaine + epinephrine

Eligibility Criteria

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

You may qualify if:

  • Scheduled to undergo mid-urethral sling for incontinence without concomitant procedures

You may not qualify if:

  • Undergoing procedure in addition to the sling
  • Not competent to give consent
  • Using intermittent self catheterization pre-operatively
  • Known allergy to local anesthetic
  • Undergoing spinal anesthesia for the procedure
  • Prisoners
  • Non-English speaker
  • Under 18 years of age
  • Has a condition that would contra-indicate the use of local anesthetic or epinephrine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

  • Duenas-Garcia OF, Patterson D, De la Luz Nieto M, Leung K, Flynn MK. Voiding Function After Midurethral Slings With and Without Local Anesthetic: Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Jan/Feb;23(1):56-60. doi: 10.1097/SPV.0000000000000343.

    PMID: 27682748DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

BupivacaineSodium ChlorideEpinephrine

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

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Limitations and Caveats

Failure to obtain 6-7 hour pain score for 24/80 participants. Impact of large preponderance of slings placed by a subrapublic approach. Study not designed to examine the effect of phenazopyridine in study.

Results Point of Contact

Title
Michael Flynn, MD
Organization
UMass Worcester
michael.flynn@umassmemorial.org
508-334-9840

Study Officials

  • Michael Flynn, MD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

April 19, 2012

First Posted

April 23, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 28, 2018

Results First Posted

November 28, 2018

Record last verified: 2018-10

Locations

US(1)