Study of U101 for Bladder Pain and/or Urgency
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
- Overall improvement in combined symptoms of pain and urgency at 3 weeks []
Secondary Outcome Measures
- Safety []
- Reduction in pain on ten point scale at 3 weeks []
- Reduction in urgency on ten point scale at 3 weeks []
- 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 []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female subjects at least 18 years of age.
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Subjects must have given written informed consent to participate in this trial.
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All female subjects, except those who are post-menopausal and/or surgically sterilized, must consent to use two medically acceptable methods of contraception throughout the entire study period. Medically acceptable methods of contraception that may be used by the subject and/or her partner include: abstinence, birth control pills, diaphragm with spermicide, intrauterine device (IUD), condom and foam, vaginal spermicidal suppository, progestin implant, and Depo-Provera injections.
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Subjects must have had symptoms of pelvic pain and/or urgency.
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Medical history and physical examination results must be clinically acceptable to the Investigator. Medical Monitor may evaluate subjects who don't meet eligibility criteria.
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Female subjects currently using hormone therapy (HT) must have been using HT for at least 3 months.
Exclusion Criteria:
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Subjects less than 18 years of age.
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Subjects with known hypersensitivity to heparin or lidocaine.
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Female subjects who have a positive pregnancy test at the time of screening, who are pregnant or lactating, or who are planning to become pregnant during the study period.
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Subjects who are chronic users of narcotics or who are using any narcotics at the time of study entry.
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Subjects who have hepatic disease or clinically significant abnormal liver function tests (more than twice the upper limit of the normal range).
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Subjects who do not expect to be available for the entire duration of the study.
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Subjects with any coexisting significant medical condition that is likely to interfere with study procedures (cardiovascular, hematological, central nervous system, pulmonary, renal, etc.)
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Subjects who have been treated with dimethyl sulfoxide (DMSO) or other bladder instillation therapies within three months prior to study entry.
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Subjects who have had cystoscopic dilatation of their bladder or urethra within three months of study entry.
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Subjects who have taken or used any investigational drug or device within 30 days before the start of the study, or who are currently enrolled in another investigational study.
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Subjects contemplating having or scheduled for any invasive surgical procedures during the study period.
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Subjects who are unwilling or unable to abide by the requirements of the study.
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History of gastrointestinal (GI) bleeding
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Active bleeding from any source
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Screening activated partial thromboplastin time (aPTT) above normal limits
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Systolic blood pressure (BP) > 180 mmHg or < 90 mmHg at Screening.
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Subjects with an actively bleeding lesion/area in the bladder as detected by urinalysis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | UCSD Medical Center | San Diego | California | United States | 92103 |
2 | Georgia Urology | Cartersville | Georgia | United States | 30120 |
3 | St. Mary's Good Samaritan | Centralia | Illinois | United States | 62801 |
4 | The Urogynecology Center | Overland Park | Kansas | United States | 66215 |
5 | Mid-Michigan Health Centers | Jackson | Michigan | United States | 49201 |
6 | Central Park Urology | New York City | New York | United States | 10019 |
7 | The Urology Center | Greensboro | North Carolina | United States | 27403 |
8 | Urologic Specialists of Oklahoma, Inc. | Tulsa | Oklahoma | United States | 74146 |
9 | Whitmore Urology Office | Philadelphia | Pennsylvania | United States | 19146 |
Sponsors and Collaborators
- Urigen
Investigators
- Principal Investigator: C. Lowell Parsons, MD, UCSD
Study Documents (Full-Text)
None provided.More Information
Publications
- URG-101