Micronized Amnion/Chorion Bilayer Injections benefits Refractory Interstitial Cystitis/Bladder Pain Syndrome patients: Study

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