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Micronized Palmitoylethanolamide-Polydatin Reduces the Painful Symptomatology in Patients with Interstitial
M Cervigni1, L Nasta2, C Schievano3
1Interstitial Cystitis Referral Center, San Carlo di Nancy Hospital, Rome, Italy.
Aims:
To assess the efficacy of a micronized-palmitoylethanolamide-polydatin (m-PEA-Pol) based product on chronic pelvic pain and severity of other symptoms in interstitial cystitis/bladder pain syndrome (IC/BPS) patients refractory to conventional therapies.
Methods:
A pilot, open-label bicentric study was carried out involving 32 IC/BPS patients. Chronic, oral m-PEA-Pol treatment lasted 6 months. Bladder pain was evaluated using the visual analog scale, while changes from baseline in other urinary symptoms were evaluated by means of the O'Leary-Sant Interstitial Cystitis Symptom and Problem Index and the Pelvic Pain and Urgency/Frequency (PUF) symptom scale questionnaires. The generalized linear mixed model was used to evaluate significant mean changes across time.
Results:
A significant and progressive reduction of pain intensity was observed during m-PEA-Pol treatment (p < 0.0001 for reduction over time). The effect was associated with a reduction in severity of patients' symptoms evaluated with the O'Leary-Sant questionnaire (p=0.0110 and p=0.0014 for cystitis symptoms and problem mean scores, respectively) and the PUF scale (p=0.0163 and p=0.0005 for symptom and bother mean scores, respectively). m-PEA-Pol therapy elicited a significant reduction over time in the urinary frequency evaluated with voiding diary (p=0.0005) and a small but not significant improvement of bladder capacity.
Conclusions:
These data highlight the potential benefit of m-PEA-Pol in patients with rare pathology such as IC/BPS and confirm the good safety profile of micronized PEA-based products.
Insights
Micronized-palmitoylethanolamide-polydatin (m-PEA-Pol) significantly reduced chronic pelvic pain and urinary symptoms in interstitial cystitis/bladder pain syndrome (IC/BPS) patients. This therapy demonstrated a good safety profile for managing this rare condition.
Area of Science:
- Urology
- Pain Management
- Pharmacology
Background:
- Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic condition causing pelvic pain and urinary dysfunction.
- Patients with IC/BPS often have refractory symptoms despite conventional therapies.
- Micronized palmitoylethanolamide-polydatin (m-PEA-Pol) is a novel therapeutic agent.
Purpose of the Study:
- To evaluate the efficacy of m-PEA-Pol in improving chronic pelvic pain and urinary symptoms in IC/BPS patients.
- To assess the safety and tolerability of m-PEA-Pol in this patient population.
Main Methods:
- A pilot, open-label, bicentric study involving 32 IC/BPS patients.
- 6-month oral administration of m-PEA-Pol.
- Pain assessed via Visual Analog Scale; symptoms evaluated using O'Leary-Sant IC Symptom and Problem Index and PUF scales; urinary frequency monitored via voiding diary.
Main Results:
- Significant progressive reduction in pain intensity (p < 0.0001).
- Significant improvement in O'Leary-Sant symptom and problem scores (p=0.0110, p=0.0014) and PUF symptom and bother scores (p=0.0163, p=0.0005).
- Significant reduction in urinary frequency (p=0.0005) and a non-significant improvement in bladder capacity.
Conclusions:
- m-PEA-Pol shows potential benefits for managing IC/BPS symptoms.
- The treatment is well-tolerated, confirming the safety of micronized PEA-based products.
- m-PEA-Pol may offer a new therapeutic option for patients with IC/BPS refractory to standard treatments.
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