Intravesical Liposomes for Ulcerative Cystitis

This study has been completed.
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals Identifier:
First received: March 8, 2010
Last updated: July 31, 2013
Last verified: July 2013
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).

Condition Intervention
Interstitial Cystitis
Drug: Liposomes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravesical Liposomes for Ulcerative Cystitis

Resource links provided by NLM:

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Change in symptom severity [ Time Frame: 4 and 8 weeks ]
    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.

Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 4 and 8 weeks ]

    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.

Enrollment: 1
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liposomes
Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
Drug: Liposomes
Intravesical instillation
Other Name: Bladder instillation

Detailed Description:

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.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01083979

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kenneth Peters, MD
Principal Investigator: Kenneth M Peters, MD William Beaumont Hospitals
  More Information

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals Identifier: NCT01083979     History of Changes
Other Study ID Numbers: 2010-021 
Study First Received: March 8, 2010
Last Updated: July 31, 2013

Additional relevant MeSH terms:
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases processed this record on January 19, 2017