Villasillo2008's Weblog

We based on the assumption that a more viscous compound than existent HA formulation, such as the one used, would be more effective in helping to restore a defective glycosaminoglycan layer. Besides, a solution consisting in a combination of HA and chondroitin sulphate, which had already been used as a single agent in IC/PBS patients ⁽⁴⁾, could produce additional benefits in patients than the use of its single components. Hyaluronic acid, also called sodium hyaluronate, was obtained in vials containing 40 ml of a clear, sterile, nonpyrogenic preparation of a high molecular weight fraction of sodium hyaluronate 1.6 % p/v associated with chondroitin sulfate 2.0 % p/v. Twenty-seven women 20 to 65 years old (mean 46.68, SD 13.63), with symptoms characteristic of Interstitial Cystitis/Painful Bladder Syndrome according to the criteria established by the National Institute of Health Consensus Conference ⁽⁵⁾ entered the trial, being recruited in two Centers.

After bladder catheterization with a sterile Nelaton catheter 10 or 12 Ch, the bladder was emptied, and the patients received endovesical administration of hyaluronic acid and chondroitin sulfate in normal saline, 40 ml, weekly for 12 weeks and then be-weekly for 6 months, if there was initial response; a single dose of oral antibiotic was administered before catheterization. The solution was maintained for 1 hour before voiding. The primary endpoint of our trial was to evaluate the efficacy of a therapeutic regimen consisting in weekly intravesical instillations of sodium hyaluronate 1.6 p/v with chondroitin sulfate 2.0 % 1.6 p/v, for a period of 12 weeks, in female patients with a diagnosis of IC/PBS. To this aim, assessment of urgency and pain by means of VAS (10 cm), reduction of number of voiding by means of voiding diary, and O’Leary-Sant IC Symptom and Problem Index ⁽⁶⁾, and PUF questionnaire ⁽⁷⁾ were used.

Outcomes were evaluated at baseline and 3 and 6 months after initiation of therapy.

Results were evaluated by comparing pre and post-treatment values of the following tests: 3-days voiding diary, O’Leary-Sant Symptom score, PUF questionnaire; VAS for urgency and pain.

The baseline values were compared to 12-week assessment and 6 months assessment. The statistical analysis was performed using the T-test for independent variables. We considered statistically significant p< 0.05.

Results

A total of 23 female patients completed the study. More than 91% of patients reported having symptoms for more than 1 year.

Mean follow-up was 5 months, range 3 to 8 months. No patient had intolerance and/or side effects related to treatment.

There were 69% who presented with moderate/severe pain and 69% with moderate/severe urgency, defined as a score of 5 or greater on the 0 to 10 VAS scale. Most patients were on concomitant oral therapies to relieve their bothersome symptoms.

The data from the analysis of the questionnaires at baseline and after 12 weeks treatment are reported in Table 1 and 2. Both Interstitial Cystitis Symptom and Problem Index and Pelvic Pain and Urgency/Frequency Symptom Scale (PUF) showed a mean significant improvement after 12 weeks of treatment.

The average number of voidings and mean voiding volumes revealed significant improvement after the 12 weeks’ treatment period, with a significant reduction and increase, respectively (Fig. 1-2); mean voiding volume increased significantly, from 143 ml to 191, which apparently was not reflected in a corresponding reduction of number of daily voids (from 15,5 to 14).

The analysis of the VAS showed the improvement reported in Table 2.

Two patients had to stop weekly intravesical treatment due to urinary tract infections observed after catheterization, and two additional patients had to stop maintenance be-weekly home self-administration of the product after completing 12 weeks intravesical treatment, due to bacterial urinary tract infections.

Conclusion

In our preliminary experience, the administration of intravesical hyaluronic acid plus chondroitin sulphate appears to be a safe and efficacious method of treatment in IC/PBS. In responsive patients, the effect appeared to persist during maintenance treatment and follow-up visits, consisting in an improvement of both urgency-frequency related symptoms and bladder/pelvic pain. No significant side effects were recorded, and concomitant oral therapies could be continued.

In order to confirm these initial encouraging results, further controlled, randomized studies are necessary with a greater number of patients and a longer follow-up.