OBJECTIVE: To evaluate the relationship between symptom reduction and satisfaction with pentosan polysulfate sodium (PPS) therapy in subjects with interstitial cystitis (IC). METHODS: A secondary analysis was conducted in 128 subjects treated withPPS 300 mg/day (US Food and Drug Administration-approved dose) from a 32-week multicenter, randomized, double-blind study of 380 subjects with IC who were treated withPPS 300 mg/day, 600 mg/day, or 900 mg/day. Self-rated outcome measures included the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) and a treatment satisfaction questionnaire. Treatment responders were defined as subjects having > or =30% reduction in ICSI from baseline to study end point. RESULTS: A reduction in IC symptoms was associated with significantly higher satisfaction with PPS (p < 0.05). Compared with nonresponders, subjects achieving a > or = 30% reduction in ICSI were more likely to be pleased with PPS for IC symptoms, to have benefited from PPS for their IC symptoms, to recommend PPS for IC symptoms to others with the same condition, and to say that PPS provides better relief, based on prior experience with other IC treatments. Among all subjects at week 32, 75% said they would recommend PPS therapy for IC symptoms to others with the condition. CONCLUSION: Despite limitations (lack of placebo control, use of a nonvalidated instrument), this analysis demonstrated significantly increased treatment satisfaction with PPS therapy among treatment responders versus nonresponders. There was a significant positive correlation between ICSI scores and response on the treatment satisfaction questionnaire. Treatment response and patient satisfaction with treatment are important clinical considerations in the management of patients with IC.
RCT Entities:
OBJECTIVE: To evaluate the relationship between symptom reduction and satisfaction with pentosan polysulfate sodium (PPS) therapy in subjects with interstitial cystitis (IC). METHODS: A secondary analysis was conducted in 128 subjects treated with PPS 300 mg/day (US Food and Drug Administration-approved dose) from a 32-week multicenter, randomized, double-blind study of 380 subjects with IC who were treated with PPS 300 mg/day, 600 mg/day, or 900 mg/day. Self-rated outcome measures included the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) and a treatment satisfaction questionnaire. Treatment responders were defined as subjects having > or =30% reduction in ICSI from baseline to study end point. RESULTS: A reduction in IC symptoms was associated with significantly higher satisfaction with PPS (p < 0.05). Compared with nonresponders, subjects achieving a > or = 30% reduction in ICSI were more likely to be pleased with PPS for IC symptoms, to have benefited from PPS for their IC symptoms, to recommend PPS for IC symptoms to others with the same condition, and to say that PPS provides better relief, based on prior experience with other IC treatments. Among all subjects at week 32, 75% said they would recommend PPS therapy for IC symptoms to others with the condition. CONCLUSION: Despite limitations (lack of placebo control, use of a nonvalidated instrument), this analysis demonstrated significantly increased treatment satisfaction with PPS therapy among treatment responders versus nonresponders. There was a significant positive correlation between ICSI scores and response on the treatment satisfaction questionnaire. Treatment response and patient satisfaction with treatment are important clinical considerations in the management of patients with IC.
Authors: Mari Imamura; Neil W Scott; Sheila A Wallace; Joseph A Ogah; Abigail A Ford; Yann A Dubos; Miriam Brazzelli Journal: Cochrane Database Syst Rev Date: 2020-07-30