Status:
WITHDRAWN
Effect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial Cystitis
Lead Sponsor:
Northwell Health
Conditions:
Interstitial Cystitis
Eligibility:
All Genders
18-80 years
Phase:
NA
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. Spec...
Detailed Description
Interstitial cystitis (IC) is a chronic bladder condition that includes symptoms of bladder or pelvic pain as well as irritative voiding symptoms (urgency, frequency, nocturia, dysuria). The syndrome ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00823030
Start Date
January 1 2009
End Date
January 1 2013
Last Update
October 14 2015
Active Locations (1)
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1
Smith Institute for Urology
Lake Success, New York, United States, 11040