Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01731470
First received: November 15, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

Interstitial cystitis/painful bladder syndrome (IC/PBS) is a poorly understood chronic disorder of unknown etiology consisting of irritative bladder symptoms and pelvic pain that dramatically affects quality of life.

Liposomes (LP), the treatment article in this proposal, were discovered in the process of exploring a "control" compound when measuring the efficacy of liposomally encapsulated capsaicin for the intravesical treatment of interstitial cystitis. Liposomes are lipid vesicles composed of concentric phospholipid bilayers, which enclose an aqueous interior. Liposomes have the ability to form a molecular film on cell and tissue surfaces and are currently being tested as possible therapeutic agents to promote wound healing. Application of liposomes at the wound surface provides a moist protective film over the wound and augments wound healing without chronic inflammatory reactions in the neodermal layer. Preclinical study data (obtained by using an IC/PBS model in Sprague-Dawley female rats) have demonstrated normalization of urinary frequency indicating that LP may be a potent protectant of the bladder mucosa against inflammation and irritation. Intravesical LP has so far demonstrated an excellent safety profile and minimal toxicity at concentrations of 2 mg/ml. Thus, we hypothesize that intravesical instillation of LP may form a molecular film on bladder ulcer surfaces in patients with IC and provide a safe, effective, and minimally invasive treatment option to alleviating symptoms.


Condition Intervention
Interstitial Cystitis
Pelvic Pain
Biological: Liposomes

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • The primary objective is to determine the impact of 4 bladder instillations of liposomes on symptoms in subjects with IC/PBS. [ Designated as safety issue: No ]
    The primary endpoint will be changes in symptom severity from baseline to the end of visits 5 and 8 as measured by the O'Leary-Sant IC Symptom and Problem Indices.


Secondary Outcome Measures:
  • The secondary objective is to determine the safety and tolerability of liposomes instilled into the bladder in subjects with IC/PBS. [ Designated as safety issue: Yes ]

    Secondary endpoints will include:

    • Changes in Global Response Assessment (GRA)
    • Assessment of adverse events
    • Changes in urinary frequency, urgency, and pelvic pain as recorded on voiding diaries at baseline and at visits 5 and 8
    • Cystoscopic changes in bladder inflammation/ulcers


Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liposomes
Liposomes
Biological: Liposomes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Written informed consent has been obtained

    • Males and females, at least 18 years of age
    • History of IC/PBS for at least 6 months documented in the medical record
    • Recurring IC/PBS symptoms
    • An average of 8 or more urine voids over a 3-day period, confirmed by the baseline voiding diary
    • Bladder pain score > 4 in the last 24 hours (assessed at screening visit)
    • Previous use of medications and/or treatment(s) for symptom relief
    • Females of child-bearing capability agree to use a reliable form of birth control (condoms and/or oral contraceptives (birth control pills)) during the 4 week course of therapy and 1 week thereafter
    • Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the voiding diaries and self-administered questionnaires

Exclusion Criteria:

  • • Subjects currently taking prescribed medications for IC/PBS will be able to continue the medications throughout the course of the study. If the patient cannot be maintained on a stable dose of the medication(s) throughout the treatment and follow-up period they will be excluded.

    • Subjects must not have had intravesical treatment(s)/bladder installations of the following medications: DMSO, lidocaine and/or heparin within 1 month prior to study visit 1
    • Pregnant or lactating
    • History of bleeding diathesis
    • Currently on anticoagulant therapy (e.g. warfarin, clopidogrel)
    • Active bleeding peptic ulcer disease
    • Obvious neurological impairment which may be affecting bladder function
    • Known allergy to liposomes and/or egg yolk
    • Current or previous participation in another therapeutic or device study within 6 months of the screening visit
    • The presence of any clinically significant systemic disease or condition that in the opinion of the investigator would make the patient unsuitable for the study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01731470

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kenneth Peters, MD
William Beaumont Hospitals
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: NCT01731470     History of Changes
Other Study ID Numbers: 2012-024
Study First Received: November 15, 2012
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystitis
Pelvic Pain
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014