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Intravesical Liposomes for Ulcerative Cystitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01083979
First Posted: March 10, 2010
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravesical Liposomes for Ulcerative Cystitis

Resource links provided by NLM:


Further study details as provided by Kenneth Peters, MD, William Beaumont Hospitals:

Primary Outcome Measures:
  • Change in Symptom and Problem Severity [ Time Frame: Baseline to 12 weeks ]
    The primary objective is to determine the impact of 4 weekly bladder instillations of liposomes on symptoms in one patient with ulcerative interstitial cystitis (IC). The primary endpoint will be assessed at the end of the study, 8 weeks after the last bladder instillation, and will be measured by the O'Leary-Sant IC Symptom and Problem Indices (ICSI-PI) questionnaire. The ICSI is composed of 4 questions that address the occurrence of IC symptoms, specifically urinary urgency, frequency, nocturia, and bladder pain. Scores range from 0 (Not at All) to 5 (Almost Always). The IC Problem Indices questionnaire is also composed of 4 questions. Each question asks the patient to indicate how big a problem each of the 4 symptoms are to them. Scores range from 0 (No Problem) to 4 (Big Problem). Responses to all 8 questions are added together to create a total ICSI-PI score. The total ICSI-PI scores ranges from 0 to 36. A lower score indicates less IC symptoms and/or related problem


Secondary Outcome Measures:
  • Bladder Appearance [ Time Frame: Baseline to 12 Weeks ]
    The secondary objective to assess treatment efficacy will compare the number of bladder ulcers pre-treatment to the number of ulcers visualized at 12 weeks, the end of the study.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01083979     History of Changes
Other Study ID Numbers: 2010-021
First Submitted: March 8, 2010
First Posted: March 10, 2010
Results First Submitted: December 24, 2013
Results First Posted: February 8, 2017
Last Update Posted: February 8, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make individual participant data available

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