Hypothesis / aims of study
Painful bladder syndrome/Interstitial cystitis (PBS/IC) is a clinical syndrome characterized by urinary frequency, increased micturition frequency, urinary urgency, and bladder and pelvic pain. The causes of PBS/IC are not fully understood, and the condition is often difficult to treat. There are no established diagnostic criteria for PBS/IC, and this has hampered the understanding of the underlying mechanisms and the development of diagnostic and treatment methods. The treatment options for PBS/IC include conservative therapy, internal medication (pain management), intravesical instillation, and electrical stimulation therapy. Bladder hydrodistention and resection or coagulation of Hunner lesions should be considered after treatment failure of multimodal conservative treatments. However, there is currently no established treatment for PBS/IC. Given the situation, complementary and alternative medicine therapies such as behavioral therapy, physical therapy, stress reduction, and dietary manipulation (DM) can be potential treatment options. This study investigated the effectiveness of intensive systematic DM (ISDM) in women with stable PBS/IC. DM might be effective for more than 2 years for Hunner type PBS/IC cases [1,2]. Therefore, after initial treatment (bladder hydrodistension, transurethral resection of Hunner lesions), the effect of DM for pain relieving, changes in intravesical findings, etc. after 2 years are examined.
Study design, materials and methods
The study included 40 female patients (age 27-88 years; 63.3 ± 2.1 [mean ± standard error]) with PBS/IC in stable condition (duration of disease: 2.9-10.0 years; 6.3 ± 0.3). We developed an original PBS/IC diet (1,500 kcal, 65 g protein, 40 g fat, 220 g carbohydrate, 1,000 ml water, 7 g salt) and randomly assigned 30 patients to group A with instructions to follow this diet for 2 years, and 10 patients to group B without instructions. We prospectively studied changes in the O’Leary-Sant Symptom Index and Problem Index (OSSI/OSPI), urinary urgency visual analog scale (VAS) score (U: 0, no urgency; 9, severe urgency), bladder/pelvic pain VAS score (P: 0, no pain; 9, worst possible pain), quality of life (QOL: 0, very satisfied; 6, very unsatisfied), and intravesical findings from before the start of treatment to 2 years after treatment.
In group A, significant improvement was observed in all evaluation items including pain from 3 months after the initiation of treatment, and the effect was observed even after 2 years (both p <0.0001. pain VAS: 6.2 → 3.2). On the other hand, in group B, no significant improvement was observed 3 months and 1 year after the initiation of treatment, and an exacerbation tendency was also observed 2 years later. In 33 cases where treatment was effective (Group A: ESSIC classification type 3C; 15/15 [100%], type 2 C; 12/15 [80.0%], Group B: ESSIC classification type 3 C; 3/4 [75.0%], type 2 C; 3/6 [50.0%]). Group A type 3 C: the ulcer was healed, and the glomerulation (MBAD [Mucosal Bleeding after Hydrodistension]) was also reduced to about 1/3 to 1/2 in 15 cases. Group A type 2 C: the reduction of the MBAD was observed in 12 cases. In group B, 3 cases of type 3C, 3 cases of type 2C, improvement findings of ulcer and MBAD area were insufficient compared with group A. No significant adverse events related to ISDM and NIDM were observed during the study period of 2 year.
Interpretation of results
Intensive systemic DM (ISDM) relieves various PBS/IC symptoms, including pain, for over than 2 years and improves quality of life. The effect was judged to be due to the improvement of the intravesical environments.