1. Nine Month Report Assessing the Safety and Effectiveness of Amniotic Bladder Therapy in Patients with Refractory Chronic Radiation Cystitis.
- Author
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Jeberaeel, J., Dhar, N., Radoiu, C., Vaishampayan, N.G., Lucas, S., Hamada, A., and Dominello, M.M.
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AMNION , *URINARY organs , *OVERACTIVE bladder , *THERAPEUTICS , *CYSTITIS - Abstract
In view of the pathophysiology of chronic radiation cystitis (CRC) that is mainly caused by activation of an inflammatory cascade leading to chronic inflammation, vascular damage and fibrosis, amniotic membrane (AM) based therapy has emerged as a potential therapeutic approach for radiation-induced tissue injury due to its immunomodulatory, vasculogenic and anti-fibrotic properties. We have previously reported that amniotic bladder therapy (ABT) provides symptomatic improvement in refractory CRC patients for up to 12 weeks. Herein, we evaluated the durability of ABT up to 36 weeks. Five consecutive CRC patients (mean age: 64 ± 20 years) recalcitrant to multiple therapies received intra-detrusor injections under general anesthesia of reconstituted 100mg micronized AM. Clinical evaluation and questionnaires (Interstitial Cystitis Symptom Index (ICSI), Interstitial Cystitis Problem Index (ICPI), Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS), Overactive Bladder (OAB) Assessment Tool) were repeated at pre-injection and at 2, 4, 8, 12, 16, 20, 24, and 36 weeks post-injection. Uroflow was done pre-injection and at 12-, 24- and 36-weeks post-injection. The safety of injections was evaluated. All five patients exhibited a progressive improvement from their baseline lower urinary tract symptoms to 20 weeks (Figure 1). At 36 weeks, improvement was maintained in four of the patients. This coincided with an improvement in voiding volume from 124 ± 21.6ml to 323 ± 59ml at 12 weeks to 264 ± 92ml at 24 weeks to 257 ± 85ml at 36 weeks. One patient's symptoms rebounded at 24 weeks, which also coincided with a worsening in voiding volume from 90ml at baseline to 230ml at 12 weeks to 100ml at 24 weeks and 36 weeks. No adverse events were observed. Our findings suggest that ABT therapy may hold promise for refractory CRC patients, however comprehensive studies are needed to validate its therapeutic potential. Additionally, further research is needed to advance our understanding of the mechanisms through which ABT addresses CRC's multifactorial disorders. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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