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

Watson Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Interstitial Cystitis; Painful Bladder Syndrome

Treatments: Drug: 2% sodium chondroitin sulfate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00919113

UR08004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 after being fully informed of the risks of participation

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 2 patient groups, including a placebo group

8 weekly bladder instillations of Uracyst

Experimental group

Description:

20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period

Treatment:

Drug: 2% sodium chondroitin sulfate

8 weekly bladder instillations of inactive control

Placebo Comparator group

Description:

20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period

Treatment:

Drug: Placebo