Effect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial Cystitis

NCT00823030 | Withdrawn

• 1 other identifier: 08-221
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the amount of improvement in bladder function and pain relief with the administration of 2% alkalinized lidocaine in patients with interstitial cystitis. Specifically, we want to see if the administration of 2% alkalinized lidocaine treatments in the bladder improves urodynamic test result values. We hope to enroll approximately 40 patients in this study. Previous research has shown that the administration of 2% alkalinized lidocaine in the bladder may improve the bladder's capacity to hold urine and urine flow rates while simultaneously providing pain relief. As part of standard of care at the Smith Institute of Urology Pelvic Pain Center, we routinely offer our IC patients 2% alkalinized lidocaine with follow up urodynamic evaluation. Our research looks to expand upon the prior studies and confirm the findings of improved bladder function and enhanced pain control of 2% alkalinized lidocaine versus placebo by performing a second urodynamic evaluation, which is not routinely performed.

Conditions

Interstitial Cystitis

Keywords

Interstitial Cystitis; Intravesical Lidocaine

Outcome Measures

Primary Outcomes (1)

• Urodynamic parameters

  2 hours, 1 baseline UDS will be checked and then another will be checked one hour after the interventional step

Secondary Outcomes (1)

• symptom scores (Global response assessment, IPSS, VAS)

  baseline, after 2nd UDS, and at 3 and 7 days after the procedure

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo instillation: 20 ml of normal saline instilled intravesically

Procedure: Urodynamic study; Other: Normal Saline

experimental arm

EXPERIMENTAL

The experimental instillation will include 8 ml of 2% lidocaine, 3 ml of sodium bicarbonate, and 9 ml of normal saline.

Procedure: Urodynamic study; Drug: Lidocaine

Interventions

Urodynamic study PROCEDURE

A small catheter will be inserted into the bladder and water will slowly be instilled through the catheter and into your bladder. A series of measurements will then be taken to assess your bladder's capacity to hold liquid, the average and maximum urine flow rates, as well as bladder filling and leak point pressure readings.

Also known as: UDS

Placebo; experimental arm

Lidocaine DRUG

20 cc of alkalinized lidocaine will be injected after the first UDS

experimental arm

Normal Saline OTHER

20 cc of normal saline will be injected into the bladder after the first UDS

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥ 18
• Clinical diagnosis of Interstitial cystitis based on the National Institute of Diabetes, Digestive and Kidney Diseases (NIDKK) criteria. According the NDIKK criteria, IC patients must have either glomerulations on cystoscopic examination or classic Hunner Ulcers and must also have either pain associated with the bladder or urinary urgency. Symptoms of abnormal urinary frequency and bladder pain/discomfort must have been present for at least 3 months prior to study entry
• Able to understand and complete a VAS/GRA/modified IPSS assessment
• Written informed consent

You may not qualify if:

• Currently asymptomatic
• Severely debilitating or urgent concurrent medical condition
• History of pelvic radiation therapy, tuberculous cystitis, neurologic disease affecting bladder function, bladder cancer, or carcinoma in situ, or urethral cancer
• Presence of bladder, urethral, or ureteral calculi
• Clinical evidence of urethritis
• Unlikely to be compliant due to unmanaged medical or psychological problem, including neurological, psychological or speech/language problems that will interfere with ability to complete the study
• Allergy to lidocaine or any of the other anesthetics in the amide family.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Smith Institute for Urology

Lake Success, New York, 11040, United States

Location

Related Publications (6)

• Parsons CL, Tatsis V. Prevalence of interstitial cystitis in young women. Urology. 2004 Nov;64(5):866-70. doi: 10.1016/j.urology.2004.06.044.

  PMID: 15533465 BACKGROUND

• Parsons CL, Housley T, Schmidt JD, Lebow D. Treatment of interstitial cystitis with intravesical heparin. Br J Urol. 1994 May;73(5):504-7. doi: 10.1111/j.1464-410x.1994.tb07634.x.

  PMID: 8012771 BACKGROUND

• Welk BK, Teichman JM. Dyspareunia response in patients with interstitial cystitis treated with intravesical lidocaine, bicarbonate, and heparin. Urology. 2008 Jan;71(1):67-70. doi: 10.1016/j.urology.2007.09.067.

  PMID: 18242367 BACKGROUND

• Asklin B, Cassuto J. Intravesical lidocaine in severe interstitial cystitis. Case report. Scand J Urol Nephrol. 1989;23(4):311-2. doi: 10.3109/00365598909180345.

  PMID: 2595329 BACKGROUND

• Parsons CL. Successful downregulation of bladder sensory nerves with combination of heparin and alkalinized lidocaine in patients with interstitial cystitis. Urology. 2005 Jan;65(1):45-8. doi: 10.1016/j.urology.2004.08.056.

  PMID: 15667861 BACKGROUND

• Srinivasan A, Shapiro E and Moldwin RM: Effects of Intravesical Lidocaine on Urodynamic Parameters in Patients with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS).

  BACKGROUND

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Robert M Moldwin, M.D.

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

US (1)