Study of U101 for Bladder Pain and/or Urgency

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Pain; Interstitial Cystitis; Bladder Diseases
• Intervention / Treatment: Drug: Alkalinized Lidocaine-Heparin

• Study Type: Interventional
• Enrollment: 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Medical Center
  • Georgia
    • Cartersville, Georgia, United States, 30120
      • Georgia Urology
  • Illinois
    • Centralia, Illinois, United States, 62801
      • St. Mary's Good Samaritan
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • The Urogynecology Center
  • Michigan
    • Jackson, Michigan, United States, 49201
      • Mid-Michigan Health Centers
  • New York
    • New York City, New York, United States, 10019
      • Central Park Urology
  • North Carolina
    • Greensboro, North Carolina, United States, 27403
      • The Urology Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Urologic Specialists of Oklahoma, Inc.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • Whitmore Urology Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Urigen
• Investigators: Principal Investigator: C. Lowell Parsons, MD, UCSD

Publications and helpful links

General 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. doi: 10.1016/j.urology.2004.08.056.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Study Completion: September 1, 2006

Study Registration Dates

• First Submitted: November 17, 2005
• First Submitted That Met QC Criteria: November 17, 2005
• First Posted (Estimate): November 21, 2005

Study Record Updates

• Last Update Posted (Estimate): September 29, 2006
• Last Update Submitted That Met QC Criteria: September 28, 2006
• Last Verified: August 1, 2006

More Information

Terms related to this study

• Keywords: interstitial cystitis; urgency; pelvic pain; frequency; Pelvic Pain and/or Urgency of Bladder Origin
• Additional Relevant MeSH Terms: Urologic Diseases; Pain; Neurologic Manifestations; Cystitis; Cystitis, Interstitial; Pelvic Pain; Urinary Bladder Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Fibrinolytic Agents; Fibrin Modulating Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anticoagulants; Lidocaine; Heparin
• Other Study ID Numbers: URG-101