Trial record 6 of 87 for:
Cystitis, Interstitial
Effect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial Cystitis
This study has been withdrawn prior to enrollment.
Sponsor:
North Shore Long Island Jewish Health System
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
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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
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, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013