Study of U101 for Bladder Pain and/or Urgency
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00256542 |
Recruitment Status :
Completed
First Posted : November 21, 2005
Last Update Posted : September 29, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pelvic Pain Interstitial Cystitis Bladder Diseases | Drug: Alkalinized Lidocaine-Heparin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Phase II Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intravesical Alkalinized Lidocaine-Heparin for the Symptoms of Pelvic Pain and/or Urgency of Bladder Origin |
Study Start Date : | January 2006 |
Study Completion Date : | September 2006 |

- Overall improvement in combined symptoms of pain and urgency at 3 weeks
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256542
United States, California | |
UCSD Medical Center | |
San Diego, California, United States, 92103 | |
United States, Georgia | |
Georgia Urology | |
Cartersville, Georgia, United States, 30120 | |
United States, Illinois | |
St. Mary's Good Samaritan | |
Centralia, Illinois, United States, 62801 | |
United States, Kansas | |
The Urogynecology Center | |
Overland Park, Kansas, United States, 66215 | |
United States, Michigan | |
Mid-Michigan Health Centers | |
Jackson, Michigan, United States, 49201 | |
United States, New York | |
Central Park Urology | |
New York City, New York, United States, 10019 | |
United States, North Carolina | |
The Urology Center | |
Greensboro, North Carolina, United States, 27403 | |
United States, Oklahoma | |
Urologic Specialists of Oklahoma, Inc. | |
Tulsa, Oklahoma, United States, 74146 | |
United States, Pennsylvania | |
Whitmore Urology Office | |
Philadelphia, Pennsylvania, United States, 19146 |
Principal Investigator: | C. Lowell Parsons, MD | UCSD |
ClinicalTrials.gov Identifier: | NCT00256542 |
Other Study ID Numbers: |
URG-101 |
First Posted: | November 21, 2005 Key Record Dates |
Last Update Posted: | September 29, 2006 |
Last Verified: | August 2006 |
interstitial cystitis pelvic pain urgency frequency Pelvic Pain and/or Urgency of Bladder Origin |
Cystitis Cystitis, Interstitial Urinary Bladder Diseases Pelvic Pain Pain Neurologic Manifestations Urologic Diseases Lidocaine Heparin Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents |