Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

Interstitial cystitis/painful bladder syndrome (IC/PBS) is a clinical syndrome in which patients report symptoms of bladder and/or pelvic pain with pressure and/or discomfort associated with urinary frequency and urgency. These symptoms vary in severity and are known to cause significant impact on quality of life. Current recommended therapies include behavior modifications, stress management practices, physical therapy, oral pharmacologic pain management agents, intravesical instillations, hydrodistension, fulguration of bladder lesions and/or triamcinolone injections, intradetrusor onabotulinumtoxin A injections, neuromodulation, and major surgery.

Amniotic membranes, Clarix FLO™, have been used to assist in wound healing in many fields of medicine, and its use has evolved over the last century to various applications in regenerative medicine. A novel study using amniotic membranes for bladder therapy has showing promising preliminary results in a small cohort study of 10 females with recalcitrant IC/PBS. These women underwent intradetrusor injections of micronized amniotic membranes and had significant improvement of voiding symptoms and bladder pain over 3 months with no adverse events. No randomized controlled trials (RCT) of amniotic bladder therapy have been conducted to date. The proposed study would be the first RCT assessing the efficacy of amniotic membrane injections with Clarix FLO™ and has the potential to make significant impacts in the management and treatment of patients with IC/PBS.

Clarix FLO™ is a sterile, particulate human amniotic membrane and umbilical cord tissue product that is aseptically processed in compliance with current Good Tissue Practices from the same donated human tissue (placenta) after determination of eligibility and placenta/cord suitability. Amniotic Membrane and Umbilical Cord products are currently designated by the FDA as tissue products under PHS Act 361 HCT/P (human cells, tissues and cellular and tissue-based products). Clarix FLO™ does not contain living cells.

Patients will then be followed with clinical evaluation and questionnaires repeated at 2, 4, 8 and 12 weeks post-operatively. Additional urine culture and post void residuals will be repeated at 2 and 4 weeks post-operatively. Primary Objective: Determine the efficacy of amniotic bladder therapy (ABT) in patients with interstitial cystitis/painful bladder syndrome (IC/PBS) as defined by clinically-significant improvement

\- Clinically-meaningful indicator defined as: 5 point reduction in Interstitial Cystitis Symptom Index (ICSI)

Secondary Objectives:

* Characterize duration of effect of ABT using clinical evaluation and the following questionnaires: * Interstitial Cystitis Symptom Index (ICSI) * Interstitial Cystitis Problem Index (ICPI) * Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) * Overactive Bladder Assessment Tool * PUF * SF-12 Health Survey * Determine if there are any adverse effects of ABT, such as urinary tract infections or acute urinary retention.

Hypothesis: ABT in patients with PBS improves clinical outcomes

• Change in Interstitial Cystitis Symptom Index Questionnaire [Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]
• Change in Interstitial Cystitis Problem Index Questionnaire [Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]
• Change in Bladder Pain/ Interstitial Cystitis Symptom Score [Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]
• Change in Overactive Bladder Assessment Tool Scores [Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]
• Change in SF-12 Health Survey Scores [Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]
• Change in Pelvic Pain and Urgency/ Frequency (PUF) Patient Symptom Scale (PUF) Scores [Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]
• Change in number of urinary tract infections as measured by medical record review [Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]