Clinical trial NCT00256542: Study of U101 for Bladder Pain and/or Urgency
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pelvic Pain
Interstitial Cystitis
Bladder Diseases
Keywords: interstitial cystitis
pelvic pain
urgency
frequency
Pelvic Pain and/or Urgency of Bladder Origin
Lead sponsor: Urigen
Sponsor class: INDUSTRY
First posted: 2005-11-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overall improvement in combined symptoms of pain and urgency at 3 weeks
Secondary outcomes:
measure: Safety
measure: Reduction in pain on ten point scale at 3 weeks
measure: Reduction in urgency on ten point scale at 3 weeks
measure: Change in number of voids/24 hours
measure: Change in average void volume
measure: Reduction in PUF score (pelvic pain, urgency/frequency) at 3 weeks
measure: Reduction in O'Leary-Sant score at 3 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Cartersville
country: United States
facility: Georgia Urology
state: Georgia
city: Centralia
country: United States
facility: St. Mary's Good Samaritan
state: Illinois
city: Overland Park
country: United States
facility: The Urogynecology Center
state: Kansas
city: Jackson
country: United States
facility: Mid-Michigan Health Centers
state: Michigan
city: New York City
country: United States
facility: Central Park Urology
state: New York
city: Greensboro
country: United States
facility: The Urology Center
state: North Carolina
city: Tulsa
country: United States
facility: Urologic Specialists of Oklahoma, Inc.
state: Oklahoma
city: Philadelphia
country: United States
facility: Whitmore Urology Office
state: Pennsylvania
Study officials:
affiliation: UCSD
name: C. Lowell Parsons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.