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

Completed · Not applicable

Conditions studied: Interstitial Cystitis, Pelvic Pain

In brief

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.

Key facts

Study ID

NCT01731470

Run by

Kenneth Peters, MD

People needed

14

Starts

2012-07-01

Expected to finish

2013-08-01

Last updated by the study team

2017-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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

You may not qualify if…

• • 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

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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