Study of U101 for Bladder Pain and/or Urgency

Phase 2

Completed

• Conditions: Pelvic Pain; Interstitial Cystitis; Bladder Diseases

• Registration Number: NCT00256542
• Lead Sponsor: Urigen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-17
• Study First Submitted QC: 2005-11-17
• Study First Posted: 2005-11-21
• Study Start: 2006-01
• Status Verified: 2006-08
• Study Completion: 2006-09
• Last Update Submitted: 2006-09-28
• Last Update Posted: 2006-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall improvement in combined symptoms of pain and urgency at 3 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

The Urogynecology Center; 🇺🇸 Overland Park, Kansas, United States

St. Mary's Good Samaritan; 🇺🇸 Centralia, Illinois, United States

Georgia Urology; 🇺🇸 Cartersville, Georgia, United States

UCSD Medical Center; 🇺🇸 San Diego, California, United States

Central Park Urology; 🇺🇸 New York City, New York, United States

Whitmore Urology Office; 🇺🇸 Philadelphia, Pennsylvania, United States

Urologic Specialists of Oklahoma, Inc.; 🇺🇸 Tulsa, Oklahoma, United States

The Urology Center; 🇺🇸 Greensboro, North Carolina, United States

Mid-Michigan Health Centers; 🇺🇸 Jackson, Michigan, United States