Intravesical Liposomes for Ulcerative Cystitis
Intravesical Liposomes for Ulcerative Cystitis
The objective is to instill liposomes reconstituted with sterile water into the bladder as a
 compassionate use treatment in one patient with ulcerative interstitial cystitis (IC).
A physician sponsored Investigation New Drug (IN) has been acquired from the FDA for
 compassionate use of this non-approved treatment in one patient from Dr. Peters' private
 practice. Since this treatment has not been used previously in the US, we propose to evaluate
 the safety and efficacy of the treatment in this one patient by comparing pre and post
 treatment symptom changes.

 Prior to treatment (visit 1) baseline measures will be assessed: vital signs,pelvic/bladder
 pain on a visual analog scale (VAS; "0" being none and "10" being severe), concomitant
 medications, Serum pregnancy test and Antiphospholipid Antibody Panel, Urine cytology,
 urinalysis (dipstick), and culture.

 At visits 2-5 (4 treatment visits) questionnaires will be completed and vital signs, pain
 VAS, post void residual (measured by bladder scan or catheter), unanticipated events, and
 voiding history (voiding diary) will also be assessed. Additionally, cystoscopy will be done
 prior to the first treatment to view the bladder lining. At each treatment visit, the
 patients will have a solution of liposomes instilled in the bladder with a catheter, retained
 for 30 minutes, and be carefully monitored for at least 1 hour after the liposomes are
 drained.

 After treatment, visits 6 and 7 (follow up) will include vital signs with VAS pain
 assessment, post void residual (PVR), urinalysis (dipstick), unanticipated events assessment,
 questionnaire completion and review of voiding diary. Visit 8 (study exit) will include the
 same parameters measured at follow up visits 6 and 7 with the addition of cystoscopy and
 Antiphospholipid Antibody Panel testing.
Inclusion Criteria:

 -  Ulcerative IC for at least 6 months documented,

 -  Negative urine cytology,

 -  Able to independently complete self administered questionnaires and voiding diaries.

 Exclusion Criteria:

 -  Pregnant or lactating,

 -  History of bleeding diathesis,

 -  On anticoagulant therapy,

 -  Active peptic ulcer disease,

 -  Obvious neurological impairment,

 -  Known allergy to liposomes.