Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis
Interstitial Cystitis
About this trial
This is an interventional treatment trial for Interstitial Cystitis
Eligibility Criteria
Inclusion Criteria:
- Women age 18 and over
- Diagnosed with Interstitial Cystitis as defined by protocol
- Able and willing to complete questionnaires and diary
- Able to comply with visit schedule including Day 14 Removal visit
- Completion of blinded study prior to enrolling in unblinded part of study
Exclusion Criteria:
- Pregnant or lactating women
- Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product
- History or presence of any condition that would make it difficult to evaluate symptoms
- Did not complete blinded study (unblinded part of study only)
Sites / Locations
- Clinical Trials of Arizona
- Citrus Valley Medical Research, Inc
- Stanford University Department of Urology
- Genitourinary Surgical Consultants
- Women's Health Specialty Care
- Grove Hill Clinical Research
- Manatee Medical Research Institute, LLC
- North Idaho Urology
- Idaho Urologic Center
- First Urology
- Regional Urology LLC
- Lahey Clinic Medical Center
- Bay State Clinical Trials, Inc
- Female Pelvic Medicine & Urogynecology
- William Beaumont Hospital
- CRC of Jackson and Southeast Urogynecology
- Sheldon Freedman, MD Ltd
- Arthur Smith Institute for Urology
- University of Rochester, Department of Urology
- Alliance Urology Specialists
- Wake Forest University Health Sciences Medical Center
- MetroHealth Medical Center
- Penn. Presbyterian Medical Center
- Medical University of South Carolina Urology Ambulatory Care
- Carolina Urologic Research Center
- Vanderbilt University Medical Center
- Integrity Medical Research
- Pacific Urological Research
- Centre for Applied Urologic Research/Kingston General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Sham Comparator
Lidocaine Releasing Intravesical System
LiRIS containing inactive substance only
Cystoscopy Procedure
Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.
LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.
No intervention. Cystoscopy procedure is performed on study Day 0 and study Day 14 to mimick active and placebo study arms without insertion of Investigational Product into the bladder.