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Where am I: Product information > Efficacy > Study 1

Study 1 - Nickel et al 20081

This real-life multicentre clinical practice study demonstrated that Uracyst is effective in relieving the symptoms of PBS/IC and reducing symptom and bother scores, thus demonstrating an improvement in patients’ quality of life.

Fifty-three patients with long-standing, moderately severe PBS/IC received Uracyst once a week for 6 weeks, then once a month for 4 months. Every patient completed the study and received a total of ten instillations.

Results

For the primary outcome at 10 weeks (after 6 weekly treatments), the responder rate* was 47.2% and demonstrated clinical significance (see figure 1). Secondary efficacy endpoints assessed the percentage of responders after 24 weeks (10 treatments) and symptom and bother scores (see figures 1, 2 and 3).

*A responder was indicated by a marked or moderate improvement on a seven-point patient Global Response Assessment (GRA) scale.

Response Rate with Uracyst1

GraphView Fig.1

Uracyst significantly improves patient quality of life1

GraphView Fig.2

Secondary endpoint measures also included differences from baseline in O’Leary-Sant Symptom/Problem Index scores over the course of the treatment, until the end of the study (24 weeks). O’Leary-Sant Symptom Score decreased by a mean of five points (p<0.001 vs. baseline) or 37% reduction after 6 instillations (6.2 points, 43% after 10 instillations; p<0.001); O’Leary-Sant Bother Score decreased by a mean of 4.3 points (p<0.001 vs. baseline) or 35% reduction after 6 instillations (5.7 points, 44% after 10 instillations; p<0.001).

Uracyst significantly reduces the symptoms of PBS/IC1

GraphView Fig.3
Pain, urgency, and frequency scores (measured on a visual analogue scale) were also measured over the course of the treatment period. Significant reductions in pain, urgency and frequency (p<0.001) scores were reported after 6 and 10 instillations. Reductions in each symptom score compared to baseline are demonstrated on the graph above.

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