Title : Amniotic bladder therapy in patients with interstitial cystitis/bladder pain syndrome
Abstract:
Introduction and Objectives: Our study hypothesis postulates that if patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) bladders exhibit increased inflammation, fibrosis, and urothelial dysfunction then treatment modalities that modulate inflammation and fibrosis, while promoting a regenerative urothelium environment may have a therapeutic effect in such patients. Amniotic membrane (AM) has been shown to foster a regenerative wound-healing environment through its anti-inflammatory and anti-fibrotic properties. In this study, we investigate the safety and efficacy of bladder injections of AM in patients with treatment resistant IC/BPS.
Methods: Fifteen consecutive IC/BPS patients (mean age 50.7 ± 14.4 years) with a median disease duration of 7 years (5-12 years) who were recalcitrant to multiple therapies including anti-cholinergic (n=15), beta-3 adrenergic agonist (n=15), tricyclic anti-depressant (n=15), anti-histamine (n=5), hydrodistension (n=15), pentosan polysulfate (n=9), vaginal valium (n=15), intravesical instillation (n=8), botulinum toxin (Botox) injection (n=15), and neuromodulation (n=5) were included in the study. Under general anesthesia patients received intra-detrusor injections of reconstituted 100mg micronized AM and were followed for 24 weeks. Clinical evaluation and patient-reported outcome measures including Interstitial Cystitis Symptom Index (ICSI), Interstitial Cystitis Problem Index (ICPI), Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS), Overactive Bladder Assessment Tool (OAB) were assessed.
Results: After amniotic bladder therapy (ABT), the lower urinary tract symptoms improved gradually up to 12 weeks in all patients. At 16 weeks, 3 patients experienced a resurgence of symptoms and requested another injection which resulted in improvement after 2, 4, and 8 weeks respectively. For the twelve patients who only received one injection, the symptoms were still significantly lower at 20 and 24 weeks compared to baseline. No safety concerns were noticed during the study.
Conclusions: Our findings suggest that ABT shows promise as a treatment for refractory IC/BPS patients. However, further study is needed to establish treatment protocol, better understand the mechanism of action and determine the durability of therapeutic response of ABT in IC/BPS.
Audience Take Away:
- Innovative Therapeutic Approach: Attendees will gain insights into the innovative use of Amniotic Bladder Therapy (ABT) as a potential breakthrough in the treatment of refractory Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Understanding the methodology and outcomes of our study will equip healthcare professionals with valuable knowledge about an alternative approach to managing this challenging condition.
- Clinical Application of Amniotic Membrane: The presentation will elucidate the clinical application of amniotic membrane in fostering a regenerative urothelial environment. Attendees will learn how the anti-inflammatory and anti-fibrotic properties of amniotic membrane can be harnessed for therapeutic purposes, expanding their toolkit for managing IC/BPS patients who are unresponsive to conventional treatments.
- Research Expansion Opportunities: This research represents a potential avenue for other faculty members to expand their own research or teaching endeavors. The study's findings could inspire further investigations into the mechanisms of action, optimal treatment protocols, and broader applications of amniotic membrane in urological and gynecological contexts.
- Practical Solutions for Treatment Resistance: For healthcare practitioners dealing with treatment-resistant IC/BPS cases, the presentation offers a practical solution in the form of Amniotic Bladder Therapy. Understanding the positive outcomes and safety profile of ABT may simplify clinical decision-making, providing a new and effective tool for addressing a challenging aspect of patient care.
