Study of U101 for Bladder Pain and/or Urgency

Study Description

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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
Pelvic Pain; Interstitial Cystitis; Bladder Diseases	Drug: Alkalinized Lidocaine-Heparin	Phase 2

Study Design

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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

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Safety
2. Reduction in pain on ten point scale at 3 weeks
3. Reduction in urgency on ten point scale at 3 weeks
4. Change in number of voids/24 hours
5. Change in average void volume
6. Reduction in PUF score (pelvic pain, urgency/frequency) at 3 weeks
7. Reduction in O'Leary-Sant score at 3 weeks

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Urigen

Investigators

Principal Investigator:	C. Lowell Parsons, MD	UCSD

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00256542 History of Changes
Other Study ID Numbers:	URG-101
First Posted:	November 21, 2005
Last Update Posted:	September 29, 2006
Last Verified:	August 2006

Keywords provided by Urigen:

interstitial cystitis; pelvic pain; urgency; frequency; Pelvic Pain and/or Urgency of Bladder Origin

Additional relevant MeSH terms:

Pelvic Pain; Cystitis; Cystitis, Interstitial; Urinary Bladder Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Urologic Diseases; Lidocaine; Calcium heparin; 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