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

This study has been completed.
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: November 13, 2016
Last verified: November 2016
  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.

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: 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:
  • Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score [ Time Frame: 4 and 8 weeks post-treatment ]
    The O'Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.


Secondary Outcome Measures:
  • Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS) [ Time Frame: 4 and 8 weeks post-treatment ]
    Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.


Enrollment: 14
Study Start Date: July 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liposomes
Liposomes
Biological: Liposomes
Intravesical instillation of liposomes.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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: dimethylsulfoxide (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
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: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: May 12, 2016
Last Updated: November 13, 2016
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No plan to share data

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

ClinicalTrials.gov processed this record on February 24, 2017