Bladder Diseases, Interstitial Cystitis, Pelvic Pain
Conditions
Keywords
interstitial cystitis, pelvic pain, urgency, frequency, Pelvic Pain and/or Urgency of Bladder Origin
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.
Interventions
DRUGAlkalinized Lidocaine-Heparin
Sponsors
Urigen
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female subjects at least 18 years of age. * Subjects must have given written informed consent to participate in this trial. * 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. * Subjects must have had symptoms of pelvic pain and/or urgency. * Medical history and physical examination results must be clinically acceptable to the Investigator. Medical Monitor may evaluate subjects who don't meet eligibility criteria. * Female subjects currently using hormone therapy (HT) must have been using HT for at least 3 months.
Exclusion criteria
* Subjects less than 18 years of age. * Subjects with known hypersensitivity to heparin or lidocaine. * 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. * Subjects who are chronic users of narcotics or who are using any narcotics at the time of study entry. * Subjects who have hepatic disease or clinically significant abnormal liver function tests (more than twice the upper limit of the normal range). * Subjects who do not expect to be available for the entire duration of the study. * Subjects with any coexisting significant medical condition that is likely to interfere with study procedures (cardiovascular, hematological, central nervous system, pulmonary, renal, etc.) * Subjects who have been treated with dimethyl sulfoxide (DMSO) or other bladder instillation therapies within three months prior to study entry. * Subjects who have had cystoscopic dilatation of their bladder or urethra within three months of study entry. * 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. * Subjects contemplating having or scheduled for any invasive surgical procedures during the study period. * Subjects who are unwilling or unable to abide by the requirements of the study. * History of gastrointestinal (GI) bleeding * Active bleeding from any source * Screening activated partial thromboplastin time (aPTT) above normal limits * Systolic blood pressure (BP) \> 180 mmHg or \< 90 mmHg at Screening. * Subjects with an actively bleeding lesion/area in the bladder as detected by urinalysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall improvement in combined symptoms of pain and urgency at 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Safety | — |
| Reduction in PUF score (pelvic pain, urgency/frequency) at 3 weeks | — |
| Reduction in O'Leary-Sant score at 3 weeks | — |
| Change in average void volume | — |
Countries
United States
Outcome results
None listed