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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00823030
First received: January 14, 2009
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Interstitial Cystitis
Procedure: Urodynamic study
Drug: Lidocaine
Other: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Effect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial Cystitis

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Urodynamic parameters [ Time Frame: 2 hours, 1 baseline UDS will be checked and then another will be checked one hour after the interventional step ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • symptom scores (Global response assessment, IPSS, VAS) [ Time Frame: baseline, after 2nd UDS, and at 3 and 7 days after the procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo instillation: 20 ml of normal saline instilled intravesically
Procedure: Urodynamic study
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.
Other Name: UDS
Other: Normal Saline
20 cc of normal saline will be injected into the bladder after the first UDS
Experimental: experimental arm
The experimental instillation will include 8 ml of 2% lidocaine, 3 ml of sodium bicarbonate, and 9 ml of normal saline.
Procedure: Urodynamic study
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.
Other Name: UDS
Drug: Lidocaine
20 cc of alkalinized lidocaine will be injected after the first UDS

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823030

Locations
United States, New York
Smith Institute for Urology
Lake Success, New York, United States, 11040
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Robert M Moldwin, M.D. North Shore Long Island Jewish Health System
  More Information

Publications:
Responsible Party: Robert Miles Moldwin, M.D., North Shore - Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00823030     History of Changes
Other Study ID Numbers: 08-221
Study First Received: January 14, 2009
Last Updated: July 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Interstitial Cystitis
Intravesical Lidocaine

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 20, 2014