Study of U101 for Bladder Pain and/or Urgency

• ClinicalTrials.gov Identifier: NCT00256542
• Recruitment Status: Completed
• First Posted: November 21, 2005
• Last Update Posted: September 29, 2006
• Sponsor: Urigen
• Information provided by: Urigen

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

Study Design

• 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

Outcome Measures

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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

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
• 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:

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