Amniotic Bladder Therapy: Intra-Detrusor Amnion-Chorion Bilayer Injection Therapy for Refractory Interstitial Cystitis/Bladder Pain Syndrome: One Year Follow Up

Document Type

Conference Proceeding

Publication Date

5-2025

Publication Title

Journal of Urology

Abstract

INTRODUCTION AND OBJECTIVE: We report efficacy of intra-detrusor micronized amnion-chorion (AC) bilayer injection therapy in 25 patients with refractory Interstitial Cystitis/Bladder Pain Syndrome (IC/ BPS) followed for 12 months. Our earlier experience with micronized amnion monolayer (AM) injection therapy in IC/BPS patients revealed an optimum response time at 12 weeks and the response lasted for 36 weeks. The placental tissue comprises 2 distinct layers - the inner AM and the outer chorionic membrane. The decision to use one layer or a combination of both in therapeutic applications requires careful consideration. Studies have established that bilayer AC grafts contain 5 times the amount of growth factors, immunomodulators, and cytokines compared to single-layer AM grafts. Therefore, the injection of the AC bilayer for IC/BPS is likely to be more effective than AM monolayer therapy. METHODS: Twenty-five consecutive IC/BPS patients (mean age 41±13 years) who were recalcitrant to multiple therapies including anti-cholinergic (n=25), beta-3 adrenergic agonist (n=25), tricyclic anti-depressant (n=24), anti-histamine (n=24), hydrodistension (n =23), pentosan polysulfate (n=23), vaginal valium (n=24), intravesical instillation (n=23), Botox injection (n=25), and neuromodulation (n=8) were included in the study. Patients received intra-detrusor injections under general anesthesia of reconstituted 100 mg micronized AC. Changes in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS), Overactive Bladder Assessment Tool (OAB), Interstitial Cystitis Symptom Index (ICSI), and Interstitial Cystitis Problem Index (ICPI), from baseline to 12 months post-injection were assessed. RESULTS: One month after injections, improvements in IC/ BPS symptom scores were noted in all patients (Figure 1a). All patients maintained a sustained clinical response at 5 months post-injection. Two patients relapsed to baseline symptoms thereafter, with 1 patient relapsing at 6 months (Figure 1c) and 1 patient at 9 months (Figure 1d). The remaining 23 patients maintained a clinical response at 12 months (Figure 1b). No adverse events were noted in the study. CONCLUSIONS: Our findings suggest that AC may improve symptoms for some refractory IC/BPS patients up to 12 months. Further studies are needed to correlate these results and assess safety in larger patient cohorts.

Volume

213

Issue

5S

First Page

e49

Last Page

e49

Comments

American Urological Association Annual Meeting, April 26-29, Las Vegas, NV

DOI

10.1097/01.JU.0001109720.83324.13.03

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