Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome

Phase

Condition

Interstitial Cystitis

Gynecological Infections

Urinary Incontinence

Treatment

N/A

Clinical Study ID

NCT00919113

UR08004

Ages > 18
Female

Study Summary

A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Are a female, 18 years or older
Have been diagnosed with IC/PBS
Are willing to provide written informed consent and authorization to disclose afterbeing fully informed of the risks of participation

Exclusion

Exclusion Criteria:

Are lactating females
Have previously received investigational products or devices within 30 days ofscreening
Have previously received Uracyst
Are currently receiving therapy with Interstim®
Have any other condition/disease which, in the opinion of the investigator, couldcompromise subject safety or confound the interpretation of study results
Are unable or unwilling to comply with protocol requirements

Study Design

July 01, 2009

December 31, 2010

Study Description

Multi-center, randomized, double-blind, parallel, 8 weekly instillations over a 7-week period with post-treatment follow-up for an additional 19 weeks for a total study length of 26 weeks.

Connect with a study center

Boulder, Colorado 80304
United States
Site Not Available
Denver, Colorado 80211
United States
Site Not Available
Farmington, Connecticut 06032
United States
Site Not Available
Plantation, Florida 33317
United States
Site Not Available
Wellington, Florida 33414
United States
Site Not Available
Columbus, Georgia 31904
United States
Site Not Available
Coeur d'Alene, Idaho 83814
United States
Site Not Available
Evanston, Illinois 60201
United States
Site Not Available
Melrose Park, Illinois 60160
United States
Site Not Available
Royal Oak, Michigan 48073
United States
Site Not Available
Las Vegas, Nevada 89148
United States
Site Not Available
Englewood, New Jersey 07601
United States
Site Not Available
Sewell, New Jersey 08080
United States
Site Not Available
Westampton, New Jersey 08060
United States
Site Not Available
Albany, New York 12206
United States
Site Not Available
Poughkeepsie, New York 12601
United States
Site Not Available
Winston-Salem, North Carolina 27103
United States
Site Not Available
Oklahoma City, Oklahoma 73104
United States
Site Not Available
Philadelphia, Pennsylvania 19104
United States
Site Not Available
Mountlake Terrace, Washington 98043
United States
Site Not Available

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