NCT03390790

Brief Summary

Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying external lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 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

October 20, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2019

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

October 20, 2017

Last Update Submit

July 18, 2019

Conditions

Voiding DisordersOveractive BladderUrinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • The change in patient visual analog pain score (vaginal area only) from before procedure to 4-6 hours after urodynamic testing

    Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).

    Baseline and 4-6 hours post procedure.

Secondary Outcomes (5)

  • Change in patient visual analog pain score (vaginal area only) from before procedure to 24 hours after urodynamic testing.

    Baseline and 24 hours post procedure.

  • Patient visual analog pain score (vaginal area only) before procedure, at conclusion of all procedure-related activities, 4-6 hours after procedure, and 24 hours after procedure.

    Baseline and 24 hours post procedure.

  • To assess voiding difficulties and other adverse events immediately after urodynamic testing, at 4-6 hours, 24 hours, and two weeks after urodynamic testing.

    Baseline and 2 weeks post-procedure.

  • Urodynamic findings

    At time of procedure.

  • Procedure time

    At time of procedure.

Study Arms (2)

Lidocaine gel

EXPERIMENTAL

If assigned to this arm, participants have lidocaine gel 2% applied to their external urethra and vagina one time prior to the urodynamics procedure.

Drug: Lidocaine gel 2%

Lubricant gel

PLACEBO COMPARATOR

If assigned to this arm, participants will have a standard lubricant gel applied to their external urethra and vagina prior to the urodynamics procedure.

Other: Standard lubricant gel

Interventions

Lidocaine gel 2%DRUG

If assigned to this intervention via randomization, participants will receive lidocaine (numbing) gel prior to their urodynamics procedure.

Lidocaine gel
Standard lubricant gelOTHER

If assigned to this intervention via randomization, participants will receive standard lubricant gel prior to their urodynamics procedure.

Lubricant gel

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All female patients between the ages of 40-80 undergoing urodynamic testing.

You may not qualify if:

  • Urinary tract infection or symptoms of infection at time of procedure or within past 2 weeks
  • History of urinary retention
  • Known or suggested history of urethral syndrome or painful bladder syndrome
  • Prior anti-incontinence surgery
  • Prior pelvic surgery with placement of transvaginal mesh
  • Known urethral or bladder anomaly including urethral diverticulum or congenital anomalies of the bladder or urethra
  • History of genital herpes outbreak within the past 3 months
  • Defects in mucosal surfaces including periurethral or vaginal abrasions, ulcerations, or lacerations
  • Neurologic disease affecting urethral sensation
  • Chronic pelvic pain
  • Contraindication or allergy to topical anesthetic
  • Pregnancy
  • Syncopal episode during preparation for or execution of uroflowometry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

Related Publications (1)

  • Avondstondt AM, Chiu S, Salamon C. Periurethral Lidocaine Does Not Decrease Pain After Urodynamic Testing in Women: A Double-Blinded Randomized Control Trial. Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):e528-e532. doi: 10.1097/SPV.0000000000000983.

    PMID: 33208652DERIVED

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination Disorders

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 20, 2017

First Posted

January 4, 2018

Study Start

January 25, 2018

Primary Completion

March 29, 2019

Study Completion

March 29, 2019

Last Updated

July 19, 2019

Record last verified: 2019-07

Locations

US(1)