Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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26 October 2015 |
Main ID: |
NCT00823030 |
Date of registration:
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14/01/2009 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial Cystitis
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Scientific title:
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Effect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial Cystitis |
Date of first enrolment:
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January 2009 |
Target sample size:
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0 |
Recruitment status: |
Withdrawn |
URL:
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https://clinicaltrials.gov/show/NCT00823030 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Robert M Moldwin, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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North Shore Long Island Jewish Health System |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Interstitial Cystitis
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Intervention(s)
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Other: Normal Saline
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Procedure: Urodynamic study
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Drug: Lidocaine
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Primary Outcome(s)
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Urodynamic parameters
[Time Frame: 2 hours, 1 baseline UDS will be checked and then another will be checked one hour after the interventional step]
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Secondary Outcome(s)
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symptom scores (Global response assessment, IPSS, VAS)
[Time Frame: baseline, after 2nd UDS, and at 3 and 7 days after the procedure]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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