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