Investigation of efficacy of pentosan polysulfate in IC/BPS with lower urinary tract symptom using portable uroflometry and flow chart.

Objective: To assess the subjective improvement in urinary symptoms and the increase in functional bladder capacity induced by Pentosan Polysulfate (PPS) in patients with Interstitial Cystitis (IC) accompanied by lower urinary tract symptoms. Methods: Patients with Interstitial Cystitis (IC) and lower urinary tract symptoms were divided into two groups: Group 1 received both an alpha-blocker and PPS, while Group 2 received only an alpha-blocker for 12 weeks. Treatment effects were compared using symptom questionnaires, a voiding diary, and a portable uroflowmetry device. Questionnaires: International Prostate Symptom Score (IPSS) Interstitial Cystitis Symptom Index (ICSI) Interstitial Cystitis Problem Index (ICPI) Pelvic Pain and Urgency/Frequency (PUF) questionnaire Portable Uroflowmetry Device: All patients were provided with a portable uroflowmetry device, trained on its operation, and instructed to use it to complete a voiding diary. The device recorded and analyzed voiding patterns, including average flow rate, average voiding frequency, average voided volume, and functional bladder capacity over a period of 3 days. Statistical Analysis: Primary outcome measure: Interstitial Cystitis Symptom Index (ICSI) Secondary outcome measures: Interstitial Cystitis Problem Index (ICPI), Pelvic Pain and Urgency/Frequency (PUF) questionnaire Tertiary outcome measures: Average maximum flow rate, frequency, nocturia frequency, and derived nocturia indices. Repeated measures ANOVA or repeated measures general linear models were applied, considering covariates such as daily total voided volume from the portable voiding diary. A total of 80 patients were enrolled, with 25 patients from each group (total 50) completing the portable voiding diary and included in the analysis. Primary Efficacy Evaluation: There was no significant age difference between the two groups (p-value 0.22). Most variables did not show significant differences between the groups, except for the IPSS total score and urinary symptom score, which were significantly different (p-value 0.042). However, storage symptoms did not show a significant difference (p-value 0.32). Since this study aimed to evaluate improvements in storage symptoms, this lack of significant difference is unlikely to affect the analysis. Secondary Efficacy Evaluation: Both groups showed significant improvements in the IPSS total score after treatment. However, Group 1 showed a more significant improvement in storage symptoms compared to Group 2 (p-value 0.672). This suggests that while both groups benefited from the alpha-blocker, Group 1 experienced additional benefits from PPS, particularly in storage symptoms. Both IPSS, ICSI, ICPI, and PUF questionnaire scores improved significantly post-treatment in both groups, with Group 1 showing greater improvement in storage symptoms compared to Group 2. Additionally, the ICSI questionnaire indicated no change in Group 2 before and after treatment, while Group 1 showed significant improvement post-treatment. Safety Evaluation: No serious adverse effects were reported in either group. Dropouts were primarily due to device malfunctions rather than drug-related side effects, despite comprehensive training provided. Conclusion: In male patients with urinary difficulties, PPS administration improved storage symptoms, leading to increased functional bladder capacity and average voided volume. For male patients with urinary symptoms similar to Interstitial Cystitis, 3 months of PPS treatment effectively improved subjective symptoms. Compared to alpha-blocker monotherapy, PPS notably improved the IPSS total score and storage symptoms, resulting in increased functional bladder capacity and single voided volume. In cases where alpha-blocker monotherapy is ineffective, PPS provides an additional option for improvement. This approach could be considered a viable alternative to anticholinergics, even in cases that are not as severe as Interstitial Cystitis.