Intravesical application of the birth tissue like amnion and chorion inside the bladder can reduce inflammation, reduce the development of excessive collagen formation, and help in the regeneration of healthy bladder tissue. Research in the past has shown that micronized (finely ground) amnion monolayer injections given to the bladder tissue have given temporary relief for IC/BPS patients who haven’t responded to traditional treatments. Hence, researchers from Wayne State University School of Medicine, Detroit, MI, USA conducted a study to evaluate the therapeutic responses and adverse events of micronized amnion/chorion bilayer (AC) in patients with refractory IC/BPS and followed up for 6 months.
About 15 IC/BPS patients, who did not respond to conventional treatments were included in the study. Each participant received about 100 mg of reconstituted micronized AC injections directly into the detrusor muscle layer by the cystoscopy method. The procedure was carried out under general anesthesia by using a 23-gauge needle. About twenty 0.5 mL injections were given across the lateral and posterior walls of the bladder avoiding certain areas of the bladder like the dome and trigone. The outcomes involved measuring Changes in interstitial cystitis symptom index (ICSI), Interstitial cystitis problem index (ICPI), Bladder pain/ interstitial cystitis symptom score (BPIC-SS), and Overactive Bladder Assessment Tool (OAB), from baseline to 6 months post-injection. A retrospective assessment of these changes was done and the safety of the injections was also analyzed.
Findings:
- About 15 total refractory IC/BPS patients who did not respond to conventional treatments were included in the study.
- The participants were of an average age of 41.1 ± 14.5 years.
- All the participants received intra-detrusor injections of 100 mg of micronized AC.
- A significant improvement in IC/BPS symptom scores was seen in all patients about a month after injections.
- Sustained clinical response was noted in all the participants at 6 months post-injection.
- No product-related adverse events were observed.
Thus, the researchers concluded that using an amnion/chorion (AC) bilayer product could be a better treatment option for individuals with interstitial cystitis/bladder pain syndrome (IC/BPS). They also found that the symptom relief was long-term of up to 6 months. This study also showed a beneficial alternative for individuals who did not respond to other therapies. The researchers also suggested further studies involving larger groups of populations to confirm the effectiveness of the treatment.
Further reading: O’Hollaren, K., Considine, J., Radoiu, C. et al. Amniotic bladder therapy: study of micronized amnion/chorion for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) at 6 months. Int Urol Nephrol (2024). Doi: https://doi.org/10.1007/s11255-024-04251-x
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