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PT224 Palmitoylethanolamide/polydatin as add-on therapy in pain resistant patients with
interstitial cystitis/bladder painful syndrome
Eur Urol Suppl 2019; 18(1);e1970
Gubbiotti M. 1, Illiano E. 2, Costantini E. 2, Giannantoni A. 3
1Istituto Serafico di Assisi, University of Perugia, Dept. of Biomedical and Surgical Sciences , Perugia, Italy, 2University of Perugia, Dept. of
Biomedical and Surgical Sciences, Andrological and Urogynaecological Clinic , Perugia, Italy, 3University of Siena, Dept. of Medical and Surgical
Sciences and Neurosciences, Siena, Italy
Introduction & Objectives: Interstitial cystitis/bladder painful syndrome (IC/BPS) is still an “enigma” 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. The present 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.
Materials & Methods: Twenty-three patients affected by IC/BPS, poorly responsive to conventional pharmacological agents, were included in
this exploratory, open label 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 was 60.7±14.2 yrs. All patients were under different oral and intravesical
poly–pharmacotherapies for IC⁄BPS, i.e. amytryptiline, nimesulid, 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. Twelve 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 (mean±SD VAS score increased from 3.6±1.3 to 6.8±1.3, p<0.01); urgency
persisted in 6 patients and UUI in 3. Three patients 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 during um-PEA/
Polydatin administration.
Conclusions: The present 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 suffering from IC/BPS. The significant pain intensity reduction could be attributed to
the downregulation of must cell degranulation via an “autacoid local inflammation antagonism” effect of um-PEA/Polydatin. Additionally, a “receptor
stimulation mechanism” on CB2 receptor-like target has been also hypothesized. 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.
Abstracts EAU19 – 34th Annual EAU Congress
Eur Urol Suppl 2019; 18(1);e1970
