Presentation Authors: Marilena Gubbiotti*, Perugia, Italy, Antonella Giannantoni, Siena, Italy
Introduction: Interstitial cystitis/bladder painful syndrome (IC/BPS) is still an &[Prime]enigma&[Prime] due to its elusive etiology and lack of curative therapy. An innovative approach in the management of chronic pain is represented by the ultramicronized palmitoylethanolamide (um-PEA), a cannabimimetic compound existing in different formulations. Um-PEA has been investigated as an analgesic agent in animal models and in clinical trials across a variety of conditions with favorable results. This study was aimed to evaluate the efficacy of um-PEA combined with Polydatin (Pelvilen®) add-on therapy in the management of pain-resistant patients suffering from IC/BPS.
Methods: 23 patients affected by IC/BPS, poorly responsive to conventional pharmacological agents, were included in this exploratory study. Patients underwent history, physical examination, urinary symptoms and pain intensity evaluation on the Visual Analogue Scale (VAS). They started assuming um-PEA/Polydatin 100 mg tablets (once daily, sublingually administered) while continuing their previous pharmacological treatments. Clinical evaluation with the 3-day voiding diary, uroflowmetry and VAS were repeated at 3 and 6 months follow-up.
Results: There were 10 males and 13 females; mean age: 60.7Â±14.2 yrs. All patients were under different oral and intravesical poly-pharmacotherapies for IC/BPS, i.e. amytryptiline, pregabalin, tapentadol, skeletal muscle relaxants, hyaluronic acid, botulinum A toxin. At baseline 34.7% of patients had bladder pain/ burning (P/B) sensation, 30.4% had urethral P/B, 17.6% had dyspareunia, 13% had anal P/B, and 4.3% had prostate P/B. 12 cases presented with urgency and 5 with urgency urinary incontinence (UUI). At the 3 mos follow-up, 20 patients (86.9%) showed a significant reduction in pain intensity (meanÂ±SD VAS score increased from 3.6Â±1.3 to 6.8Â±1.3, p < 0.01); urgency persisted in 6 pts and UUI in 3. Three pts stopped assuming um-PEA/Polydatin due to lack of efficacy. At the 6 mos follow-up, pain significantly decreased in 75% of patients and it completely disappeared in 25 cases (5/20). No side effects have been recorded.
Conclusions: This observational study provides preliminary evidence on the efficacy and safety of um-PEA/Polydatin as an add-on treatment to conventional pharmacological regimens in patients with IC/BPS. The significant pain intensity reduction could be attributed to the downregulation of must cell degranulation via an &[Prime]autacoid local inflammation antagonism&[Prime] effect of um-PEA/Polydatin. Future studies should be addressed to investigate the benefits of this pharmacological agent, alone or in combination, in the treatment of patients with IC/BPS.