Intravesical Liposomes for Ulcerative Cystitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01083979
First received: March 8, 2010
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ 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.


Secondary Outcome Measures:
  • 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.



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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083979

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

No publications provided

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01083979     History of Changes
Other Study ID Numbers: 2010-021
Study First Received: March 8, 2010
Last Updated: July 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystitis, Interstitial
Cystitis
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014