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

Primary Purpose

Interstitial Cystitis, Pelvic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liposomes
Sponsored by
Kenneth Peters, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • William Beaumont Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liposomes

Arm Description

Liposomes

Outcomes

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
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)
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.

Full Information

First Posted
November 15, 2012
Last Updated
November 13, 2016
Sponsor
Kenneth Peters, MD
Collaborators
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT01731470
Brief Title
Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
Official Title
Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Peters, MD
Collaborators
William Beaumont Hospitals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Pelvic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liposomes
Arm Type
Experimental
Arm Description
Liposomes
Intervention Type
Biological
Intervention Name(s)
Liposomes
Intervention Description
Intravesical instillation of liposomes.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
4 and 8 weeks post-treatment
Secondary Outcome Measure Information:
Title
Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)
Description
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.
Time Frame
4 and 8 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth M Peters, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data
Citations:
PubMed Identifier
25209396
Citation
Peters KM, Hasenau D, Killinger KA, Chancellor MB, Anthony M, Kaufman J. Liposomal bladder instillations for IC/BPS: an open-label clinical evaluation. Int Urol Nephrol. 2014 Dec;46(12):2291-5. doi: 10.1007/s11255-014-0828-5. Epub 2014 Sep 11.
Results Reference
derived

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

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