Pelvic Pain Clinical Trial
Official title:
Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
Verified date | November 2015 |
Source | William Beaumont Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | December 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | William Beaumont Hospital | Royal Oak | Michigan |
Lead Sponsor | Collaborator |
---|---|
Kenneth Peters, MD | William Beaumont Hospitals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective is to determine the impact of 4 bladder instillations of liposomes on symptoms in subjects with IC/PBS. | 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. | 5 weeks | No |
Secondary | The secondary objective is to determine the safety and tolerability of liposomes instilled into the bladder in subjects with IC/PBS. | 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 |
5 weeks | Yes |
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