Contribution of Urethral Sensory Feedback in Voiding Efficiency

NCT03637582 | Completed DMC

• 1 other identifier: Pro00071589_1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how urethral anesthesia 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 Anesthesia

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

• Presence or absence of voiding dysfunction

  duration of urodynamic study, 2 hours

• Visual analog scale scores

  duration of urodynamic study, 2 hours

Study Arms (2)

Anesthesia Arm

ACTIVE COMPARATOR

Participants randomized to this arm will undergo uroflow studies then be given an hour rest. Five ml of 4% lidocaine gel will be inserted into the urethra during their hour rest. After the incubation period, the subject will receive another five ml of 4% lidocaine gel. The subject will then perform the second uroflow study. Complex urodynamics with the use of lidocaine hydrochloride 4% will then be performed. The lidocaine gel will have been placed in and around the urethra. We are using lidocaine gel in an FDA approved manner (for anesthesia).

Drug: lidocaine gel

Placebo Arm

PLACEBO COMPARATOR

Participants randomized to this arm will first undergo uroflow studies then be given an hour rest. Five ml of plain aqueous gel will be inserted into the urethra during their hour rest. After the incubation period, the subject will receive another five ml of plain aqueous gel. Urodynamic testing without anesthesia (standard of care) will then be performed.

Other: Plain aqueous gel

Interventions

lidocaine gel DRUG

Lidocaine (4%) gel from Quest Products, Inc.

Also known as: 4% lidocaine

Anesthesia Arm

Plain aqueous gel OTHER

KY jelly lubricant from Reckitt Benckiser

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
• 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
• Alcoholism or failed CAGE questionnaire
• Abnormal baseline uroflow

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Campus

Durham, North Carolina, 27708, United States

Location

Related Publications (5)

• 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 BACKGROUND

• McKee DC, Gonzalez EJ, Amundsen CL, Grill WM. Randomized Controlled Trial to Assess the Impact of High Concentration Intraurethral Lidocaine on Urodynamic Voiding Parameters. Urology. 2019 Nov;133:72-77. doi: 10.1016/j.urology.2019.08.020. Epub 2019 Aug 26.

  PMID: 31465791 RESULT

MeSH Terms

Conditions

Urinary Bladder, Underactive

Interventions

Lidocaine

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)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Warren M Grill, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

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: August 16, 2018
• First Posted: August 20, 2018
• Study Start: November 26, 2018
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: November 14, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)