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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intravesical Liposomes for Ulcerative Cystitis|
- Change in symptom severity [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]The primary objective is to determine the impact of 4 weekly bladder instillations of liposomes on symptoms in one patient with ulcerative IC. The primary endpoint will be changes in symptom severity from baseline to the end of weeks 4 and 8 as measured by the O'Leary-Sant IC Symptom and Problem Indices (ICSI-PI) questionnaire.
- Safety and Tolerability [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
The secondary objective is to determine the safety and tolerability of liposomes instilled into the bladder as a compassionate use treatment in one patient with ulcerative IC. Secondary endpoints will include:
Assessment of adverse events; changes in urinary frequency, urgency, and pelvic pain as recorded on voiding diaries at baseline, and at 4 and 8 weeks; cystoscopic changes in bladder inflammation/ulcers.
|Study Start Date:||August 2010|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
Other Name: Bladder instillation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083979
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Kenneth M Peters, MD||William Beaumont Hospitals|