Effect of Urethral Analgesia on Voiding

NCT02823431 | Completed Results DMC

• 1 other identifier: Pro00071589
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how urethral analgesia impacts voiding efficiency in healthy women. The investigator hypothesizes that anesthetizing the urethral with lidocaine gel will decrease voiding efficiency as measured by standard bladder testing (urodynamic testing).

Conditions

Urethral Analgesia

Keywords

voiding efficiency; detrusor underactivity; urodynamics

Outcome Measures

Primary Outcomes (1)

• Voiding Efficiency

  voided volume/{voided volume + residual volume} during micturition study during urodynamic studies

  duration of urodynamic study, 2 hours

Secondary Outcomes (3)

• Detrusor Pressure at Maximum Flow

  duration of urodynamic study, 2 hours

• Number of Participants With Interrupted Urinary Flow Pattern During Micturition

  duration of urodynamic study, 2 hours

• Visual Analog Scale Scores (Measure of Discomfort) After Catheterization

  duration of urodynamic study, 2 hours

Study Arms (2)

Analgesia Arm

ACTIVE COMPARATOR

Participants randomized to this arm will undergo uroflow studies then be given a 2-hour rest. Urodynamics with the use of Urojet (lidocaine hydrochloride 2%) will then be performed. The lidocaine gel will be placed in and around the urethra. It will be allowed to set for 3 minutes, then the remainder of the standard urodynamic evaluation will be performed. We are using Urojet (lidocaine gel) in an FDA approved manner (for analgesia).

Drug: lidocaine gel

Placebo Arm

PLACEBO COMPARATOR

Participants randomized to this arm will first undergo uroflow studies then be given a 2-hour rest. Urodynamic testing without analgesia (standard of care) will then be performed.

Other: Plain aqueous gel

Interventions

lidocaine gel DRUG

Also known as: Urojet 2% gel

Analgesia Arm

Plain aqueous gel OTHER

Also known as: KY gel

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females ages 18-60 years

You may not qualify if:

• Able to provide informed consent and agree to the risks of the study
• Willing to abstain from caffeine and alcohol for 24 hours
• Willing to avoid taking anticholinergic medications (for reasons other than incontinence; e.g., diphenhydramine) for one week prior to the procedure
• Pelvic organ prolapse past the hymen
• Multiple sclerosis, myasthenia gravis, Parkinson's Disease, stroke within the past 6 months
• Interstitial cystitis / Bladder Pain Syndrome
• Recurrent (≥ 3/year) urinary tract infections
• Positive pregnancy test at the time of consent
• ≤ 6 weeks postpartum or if breastfeeding
• Positive urine dip (\>+1nitrites or \>1+LE) and urinary symptoms at the time of consent
• \>1+ blood on urinary dip
• Morbid obesity (BMI \>40)
• Taking anticholinergic medications for urinary incontinence
• \>2 replies of ≥ "sometimes" on the Lower Urinary Tract Symptoms questionnaire at the time of consent

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Campus

Durham, North Carolina, 27708, United States

Location

Related Publications (4)

• Chen SC, Grill WM, Fan WJ, Kou YR, Lin YS, Lai CH, Peng CW. Bilateral pudendal afferent stimulation improves bladder emptying in rats with urinary retention. BJU Int. 2012 Apr;109(7):1051-8. doi: 10.1111/j.1464-410X.2011.10526.x. Epub 2011 Aug 23.

  PMID: 21883860 BACKGROUND

• Peng CW, Chen JJ, Cheng CL, Grill WM. Improved bladder emptying in urinary retention by electrical stimulation of pudendal afferents. J Neural Eng. 2008 Jun;5(2):144-54. doi: 10.1088/1741-2560/5/2/005. Epub 2008 Apr 22.

  PMID: 18430976 BACKGROUND

• Shafik A, Shafik AA, El-Sibai O, Ahmed I. Role of positive urethrovesical feedback in vesical evacuation. The concept of a second micturition reflex: the urethrovesical reflex. World J Urol. 2003 Aug;21(3):167-70. doi: 10.1007/s00345-003-0340-5. Epub 2003 Jul 25.

  PMID: 12898170 BACKGROUND

• Kisby CK, Gonzalez EJ, Visco AG, Amundsen CL, Grill WM. Randomized Controlled Trial to Assess the Impact of Intraurethral Lidocaine on Urodynamic Voiding Parameters. Female Pelvic Med Reconstr Surg. 2019 Jul/Aug;25(4):265-270. doi: 10.1097/SPV.0000000000000544.

  PMID: 29300256 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Underactive

Interventions

Gels

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Warren Grill PhD
• Organization: Duke Biomedical Engineering

warren.grill@duke.edu

(919) 660-5276

Study Officials

• Warren Grill

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: July 6, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 27, 2018
• Results First Posted: July 27, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)