Liposomal bladder instillations for IC/BPS: an open‐label clinical evaluation
Int Urol Nephrol 11 Sept. 2014
This publication describes the 14-patient open-label clinical trial conducted at the William Beaumont Hospital, completed in August 2014. In this study, the 14 patients were treated with LP-08 once per week for four weeks then were observed for eight weeks. Pain and urgency scores, as self reported by the patients on a visual analog scale (VAS), were reduced on average 8 weeks and 12 weeks from the onset of treatment. The chart to the left illustrates the aggregate pain score data (shown as probability density functions, similar to histograms) observed in the study. Similar results were observed for urgency scores.
Novel therapy with intravesical liposomes for ulcerative interstitial cystitis/painful bladder syndrome
LUTS 4 (1) 51–53 2012
A 48-year-old woman, diagnosed with ulcerative IC/PBS, received four weekly instillations of intravesical liposomes. Subsequently she was evaluated for 8 weeks. No side effects or adverse events were reported. Voids per day decreased from a baseline of 18 voids per 24 h to 12.6 voids per 24 h at 8 weeks after final instillation. Urgency score also decreased. Bladder ulcers noted by cystoscopy at baseline were absent at the 8 weeks post-treatment. Cystoscopic images of this ulcer resolution are shown in the images to the left.
Intravesical Liposome Versus Oral Pentosan Polysulfate for Interstitial Cystitis/Painful Bladder Syndrome
J. Urol. 182, 1393-1400, 2009
A group of 12 interstitial cystitis (IC) patients were treated with LP-08, then a second group of 12 patients were treated with Elmiron. The groups were not randomized. Both groups had symptom improvement from baseline. Baseline symptoms for the LP-08 group were more severe than those for the Elmiron group. The LP-08 group had a larger improvement, but the comparative increase in improvement was not statistically significant for the small number of patients. The chart shown on the left illustrates the data for urgency scores of the LP-08 group at baseline and four and eight weeks after the onset of LP-08 treatment.
Instillation of liposomes vs dimethyl sulphoxide or pentosan polysulphate for reducing bladder hyperactivity
BJU International 104, 1689–1692, 2009
LP-08 was tested in a rat model of interstitial cystitis where efficacy was measured via the period between bladder contractions (inter-contraction interval or ICI). An increase in ICI indicates an improvement in IC symptoms. The chart to the left summarizes results from the study, where "infusion type" represents the three drugs studied, "PPS" represents pentosan-polysulfae (or Elmiron), and where "LP" represents LP-08. Note that LP-08 had the most efficacy of the three therapeutic options.
Activity of different phospholipids in attenuating hyperactivity in bladder irritation
BJU International 101, 627–632, 2007
The effect of liposomes prepared from various natural and synthetic lipids were evaluated in a rat bladder injury model in the absence or the presence of cholesterol and to elucidate the key structural elements necessary for the efficacy of liposomes required for alleviating bladder hyperactivity.
Intravesical liposome administration - a novel treatment for hyperactive bladder in the rat
Urology 61: 656–663, 2003
Shown on the left is an example of a cystometrogram (CMG) tracing, which is a chart of luminal bladder pressure over time. In this case, the pressure is of a sedated rat, having an injured bladder, that was treated with "empty" liposomes, or LP-08. Download the full manuscript for the complete description of how the liposomes, containing no active agents, were able to attenuate chemically induced bladder hyperactivity in a rat interstitial cystitis model.
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Bladder Instillation of Liposomes for Bladder Coating and Drug Delivery Platform
LUTS 1, S90–S93, 2009
The clinical use of exogenous polysaccharides for the treatment of interstitial cystitis (IC) has lent credence to the concept of a dysfunctional urothelium as the cause of lower urinary tract symptoms (LUTS). Studies have shown that lipids in the apical membrane of the urothelium form an integral component of the permeability barrier in the bladder. This premise is supported by the therapeutic effect of empty liposomes in the irritated bladder. Instillation of liposomes comprised of natural phospholipids can augment bladder barrier function and support repair following injury from protamine sulfate and irritation with high potassium concentration.
Local Drug Delivery to Bladder Using Technology Innovations
Urol Clin N Am 33, 519–530, 2006
Pharmacologic management of diseases typically affecting the bladder frequently require drug administration by way of a catheter into the bladder. Drug delivery by this route, referred to as intravesical delivery, allows drug delivery at the desired site with reduced systemic side effects compared with oral delivery systems. These characteristics ensure maximal therapeutic benefit to occur at the desired site and provide genuine benefits for patients who have morbid adverse effects from oral administration. Bladder cancer, cystitis, and neurogenic bladder are the common conditions managed by this form of drug administration.