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Trial record 58 of 158 for:    interstitial cystitis

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

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. Identifier: NCT01731470
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : January 10, 2017
Last Update Posted : January 10, 2017
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals

Brief Summary:

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 or disease Intervention/treatment Phase
Interstitial Cystitis Pelvic Pain Biological: Liposomes Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
Study Start Date : July 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Liposomes
Biological: Liposomes
Intravesical instillation of liposomes.

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01731470

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals Identifier: NCT01731470     History of Changes
Other Study ID Numbers: 2012-024
First Posted: November 21, 2012    Key Record Dates
Results First Posted: January 10, 2017
Last Update Posted: January 10, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data

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