Page 98 - ITPS-7-2

INNOSC Theranostics and
Pharmacological Sciences ABT for NDO

However, the loss of supraspinal neuronal connections beta-3 adrenergic agonists, and intravesical therapy with
to the bladder after SCI can induce a series of complex botulinum toxin injections. All patients had traumatic
5
reactions, namely urothelial cell death, inflammation, SCI and were using intermittent self-catheterization to
urinary tract infection (UTI), urinary incontinence, bladder empty the bladder. The study was approved by the local
hypertrophy, and fibrosis, which impair the contractile institutional review board committee (IRB-22-12-5277).
properties of the bladder and make it difficult to maintain We excluded patients with evidence of upper urinary
low bladder pressures while storing urine. Subsequently, tract damage, pregnancy, prior radiotherapy, intra-
1
as the bladder pressure increases, the risk of more serious vesical stones, acute UTI, and a history of bladder and/
complications (e.g., upper urinary tract deterioration and or pelvic cancers. We also excluded the patients who
autonomic dysreflexia [AD] incidence) increases. Hence, had used intravesical botulinum toxin (Botox) within
the treatment of NDO primarily aims to protect the upper 6 months before the commencement of the study to avoid
tract from damage by decreasing bladder pressure, which interference with the results. The patients did not receive
can be achieved by impeding the processes of bladder additional anticholinergics or beta-3 agonists after ABT.
inflammation, fibrosis, urothelial cell death, neural
sensitization, detrusor dyssynergia, incontinence, UTI, and Baseline evaluation included history, physical
AD. NDO after SCI is often managed with intermittent examination, serum chemistries, urinalyses, urine culture,
catheterization as well as indwelling catheters (often the q4 urine cytology, cystoscopy, renal ultrasound, urodynamic
to q6 hour regimen) and potentially reflex voiding. examination (i.e., cystometry by filling the bladder at a rate of
20 mL/min and recording storage pressures), and symptom
The amniotic membrane (AM) is the inner part of the assessment as measured by the Qualiveen questionnaire.
placenta that forms a sac around the fetus during pregnancy. The urodynamic parameters were analyzed according to
This biological tissue is inherently known to provide therapeutic the standardization report of the International Continence
properties for the treatment of different pathologies. It has Society. The assessments conducted included maximum
been used clinically over the last century for applications such detrusor pressure (MDP; cmH O) and volume (mL) for the
as dermal wound covering and ocular surface reconstruction first IDC, as well as MCC corresponding to the volume (mL)
2
to promote apoptosis of pro-inflammatory cells, prevent at which involuntary voiding occurred and/or filling was
differentiation of pro-fibrotic cells, and promote expedited stopped. In the absence of involuntary voiding bladder and
wound healing. Based on these properties, the use of AM in without spontaneous bladder contractions, filling was stopped
2
amniotic bladder therapy (ABT) may overcome the limitations at 500 mL. To calculate detrusor compliance (as measured by
in the current management of NDO. We have previously the change in volume over the change in detrusor pressure),
evaluated ABT in patients with interstitial cystitis/bladder detrusor pressure was measured when the bladder was
pain syndrome, idiopathic detrusor overactivity (IDO), empty and at MCC. Clinical evaluation and questionnaires
and radiation cystitis (RC), and we observed symptomatic were repeated at weeks 2, 4, 8, and 12. Urodynamics were
improvement as early as 2-week post-injection without any repeated at weeks 4 and 12. Local or systemic side effects
complications. This observed that symptomatic improvement
3
was associated with an improvement in urodynamic were evaluated during and after treatment. AD was evaluated
assessments, including a significant increase in maximum at baseline and repeated at weeks 2, 4, 8, and 12 by asking
cystometric capacity. In addition, we evaluated the use of ABT the patients the following questions: “do you have episodes
in the management of NDO, specifically in patients with SCI, of AD (a condition where blood pressure rises very fast,
based on the safety profile and potential benefits in recalcitrant usually because of a painful stimulus below the level of your
patients with limited treatment options. Herein, ABT was lesion, resulting in symptoms such as headaches, sweating,
2,4
applied intraoperatively directly into the detrusor based on the goosebumps)? If so, how many?”
anti-inflammatory and anti-fibrotic properties of AM and the ABT was standardized among all patients. In brief,
inflammatory and fibrotic processes in the pathophysiology of patients were given intra-detrusor injections of 100 mg
NDO. micronized AM (Clarix Flo; BioTissue, USA) diluted in
10 mL 0.9% preservative-free sodium chloride. Injections
2. Methods were performed through a cystoscope using a 23-gauge

The patients enrolled in this study had terminal NDO, Williams needle into the lateral and posterior bladder walls,
defined as those who experienced involuntary detrusor sparing the dome (to avoid intraperitoneal injection) and
contractions (IDC) near or at the maximum cystometric the trigone (because of the possible risk of reflux) under
capacity (MCC) in the setting of a clinically relevant general anesthesia. A standardized procedure was followed
neurologic disease and who had failed previous treatment for all patients, with twenty 0.5 mL injections delivered into
modalities, including oral therapies with anticholinergics, two rows of ten throughout the lateral and posterior bladder

Volume 7 Issue 2 (2024) 2 doi: 10.36922/itps.2037