Severity of interstitial cystitis symptoms and quality of life in female patients.

OBJECTIVE: Interstitial cystitis (IC) is a visceral pain syndrome with a profound impact on quality of life (QOL). The main aims of the current study are as follows: (1) to determine possible factors that may increase the severity of symptoms and decrease QOL in women diagnosed with IC; (2) to study how symptom severity affects QOL adjusting for these factors; and (3) to investigate which symptom is most likely to impair IC patients' physical and mental QOL. METHODS: Forty-one women (age, 20-71 years) with moderate/severe IC enrolled in a clinical trial of intravesical pentosan polysulfate sodium in California (USA) were included in this cross-sectional analysis. Demographic and clinical characteristics were evaluated at baseline using the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI), pain assessment, urgency scale, voiding log for 24 h, and the Short Form-36 (SF-36). RESULTS: Being currently unmarried was associated with more severe symptoms. Being unemployed, currently unmarried, obese, never pregnant, and ever use of oral contraceptive were associated with a decrement in at least one QOL domain. Symptom severity was an independent predictor of worse QOL on three domains: bodily pain, general health, and mental health. Pain and nocturia were the only symptoms found to be associated with decline in overall physical quality of life. None of the symptoms had significant impact on the mental component summary of QOL. CONCLUSIONS: Symptom severity and being currently unmarried were found to be associated with impairment in QOL in IC patients. Managing pain and nocturia may improve the patients' overall physical QOL.

Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome.

OBJECTIVE: To assess the immediate and sustained relief of the symptoms of interstitial cystitis/painful bladder syndrome (IC/PBlS) after a consecutive 5-day course of treatment with intravesical alkalinized lidocaine (PSD597), and to characterize the pharmacokinetics of single and multiple doses of intravesical PSD597 in a subgroup of patients. PATIENTS AND METHODS: In all, 102 adult patients (99 women) with a clinical diagnosis of IC/PBlS were randomized from 19 centres in the USA and Canada to receive a daily intravesical instillation of PSD597 (200 mg lidocaine, alkalinized with a sequential instillation of 8.4% sodium bicarbonate solution, to a final volume of 10 mL) or placebo (double-blind), for 5 consecutive days. Patients were followed at intervals up to 29 days after the first instillation. Efficacy was assessed by changes in the Global Response Assessment (GRA), Likert scales for bladder pain, urgency and frequency, and validated O'Leary-Sant IC symptom and problem indices. RESULTS: Significantly more patients treated with PSD597 rated their overall bladder symptoms as moderately or markedly improved on the GRA scale 3 days after completing the 5-day course of treatment (30% and 9.6%, respectively, for patients treated with PSD597 and placebo; P = 0.012). The treatment effects were also maintained beyond the end of treatment and are further supported by the secondary endpoints, including symptom and problem indices. The peak serum lidocaine concentration during the study was <2 microg/mL, and well below the toxic level (>5 microg/mL). CONCLUSION: This preliminary study showed that PSD597 was effective for providing sustained amelioration of symptoms of IC/PBlS beyond the acute treatment phase. The drug was safe, well tolerated and devoid of the systemic side-effects often experienced with oral drug administration. Long-term studies are needed to determine the optimum regimen to maintain this favourable treatment effect.

Safety and efficacy of the use of intravesical and oral pentosan polysulfate sodium for interstitial cystitis: a randomized double-blind clinical trial.

PURPOSE: We examined the safety and the efficacy of a combination of intravesical and oral pentosan polysulfate sodium in comparison to only oral pentosan polysulfate sodium in treating interstitial cystitis. MATERIALS AND METHODS: A total of 41 females diagnosed with interstitial cystitis were randomized to receive a combination of intravesical pentosan polysulfate sodium plus oral pentosan polysulfate sodium (21 in treatment group) or intravesical placebo plus oral pentosan polysulfate sodium (20 in placebo group) for 6 weeks. All subjects continued to receive oral pentosan polysulfate sodium for another 12 weeks. The primary outcome was the change in the O'Leary-Sant Interstitial Cystitis Symptoms/Problem Index from baseline to week 6, 12, and 18. Other outcomes included: the changes in Pelvic Pain and Urgency Frequency questionnaire, Health Related Quality of Life index: SF-36, pain scale, urgency scale, voiding log, patient global assessment, and sexual function scales. RESULTS: The change in the total score of O'Leary-Sant Interstitial Cystitis Symptoms/Problems Index from baseline to week 12 among the treatment group (median -12 or approximately a 46% reduction) was significantly greater compared to the placebo group (median -5.5 or approximately a 24% reduction, p = 0.04). At week 18 the treatment group showed statistically significant improvement in all Health Related Quality of Life domains compared to the baseline (p < or = 0.01), while the placebo group showed significant improvement in only 3 Health Related Quality of Life domains, (p < or = 0.05) compared to the baseline. There were no significant differences within major categories of adverse events between treated and placebo groups. CONCLUSIONS: The use of intravesical pentosan polysulfate sodium simultaneously with oral pentosan polysulfate sodium is a safe and effective therapeutic option. These findings will open a new option for patients with interstitial cystitis to reduce their severely devastating symptoms and to improve their quality of life and well-being.