search
Back to results

Study of U101 for Bladder Pain and/or Urgency

Primary Purpose

Pelvic Pain, Interstitial Cystitis, Bladder Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Alkalinized Lidocaine-Heparin
Sponsored by
Urigen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain focused on measuring interstitial cystitis, pelvic pain, urgency, frequency, Pelvic Pain and/or Urgency of Bladder Origin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSD Medical Center
  • Georgia Urology
  • St. Mary's Good Samaritan
  • The Urogynecology Center
  • Mid-Michigan Health Centers
  • Central Park Urology
  • The Urology Center
  • Urologic Specialists of Oklahoma, Inc.
  • Whitmore Urology Office

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2005
Last Updated
September 28, 2006
Sponsor
Urigen
search

1. Study Identification

Unique Protocol Identification Number
NCT00256542
Brief Title
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

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Urigen

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain, Interstitial Cystitis, Bladder Diseases
Keywords
interstitial cystitis, pelvic pain, urgency, frequency, Pelvic Pain and/or Urgency of Bladder Origin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alkalinized Lidocaine-Heparin
Primary Outcome Measure Information:
Title
Overall improvement in combined symptoms of pain and urgency at 3 weeks
Secondary Outcome Measure Information:
Title
Safety
Title
Reduction in pain on ten point scale at 3 weeks
Title
Reduction in urgency on ten point scale at 3 weeks
Title
Change in number of voids/24 hours
Title
Change in average void volume
Title
Reduction in PUF score (pelvic pain, urgency/frequency) at 3 weeks
Title
Reduction in O'Leary-Sant score at 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Lowell Parsons, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Georgia Urology
City
Cartersville
State/Province
Georgia
ZIP/Postal Code
30120
Country
United States
Facility Name
St. Mary's Good Samaritan
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
The Urogynecology Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Mid-Michigan Health Centers
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Central Park Urology
City
New York City
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
The Urology Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Urologic Specialists of Oklahoma, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Whitmore Urology Office
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15667861
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.
Results Reference
background

Learn more about this trial

Study of U101 for Bladder Pain and/or Urgency

We'll reach out to this number within 24 hrs