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The purpose of this study is to determine whether intravesical U101 (alkalinized lidocaine-heparin) treatment reduces the symptoms of pelvic pain and/or urgency of bladder origin.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alkalinized Lidocaine-Heparin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Overall improvement in combined symptoms of pain and urgency at 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | ||
| Reduction in pain on ten point scale at 3 weeks | ||
| Reduction in urgency on ten point scale at 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C. Lowell Parsons, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center | San Diego | California | 92103 | United States | ||
| Georgia Urology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15667861 | Background | Parsons CL. Successful downregulation of bladder sensory nerves with combination of heparin and alkalinized lidocaine in patients with interstitial cystitis. Urology. 2005 Jan;65(1):45-8. doi: 10.1016/j.urology.2004.08.056. |
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| ID | Term |
|---|---|
| D017699 | Pelvic Pain |
| D018856 | Cystitis, Interstitial |
| D001745 | Urinary Bladder Diseases |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Change in number of voids/24 hours |
| Change in average void volume |
| Reduction in PUF score (pelvic pain, urgency/frequency) at 3 weeks |
| Reduction in O'Leary-Sant score at 3 weeks |
| Cartersville |
| Georgia |
| 30120 |
| United States |
| St. Mary's Good Samaritan | Centralia | Illinois | 62801 | United States |
| The Urogynecology Center | Overland Park | Kansas | 66215 | United States |
| Mid-Michigan Health Centers | Jackson | Michigan | 49201 | United States |
| Central Park Urology | New York | New York | 10019 | United States |
| The Urology Center | Greensboro | North Carolina | 27403 | United States |
| Urologic Specialists of Oklahoma, Inc. | Tulsa | Oklahoma | 74146 | United States |
| Whitmore Urology Office | Philadelphia | Pennsylvania | 19146 | United States |
| D003556 | Cystitis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |