Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Women's Studies, Urology, Urology |
| Therapuetic Areas: | Nephrology / Urology, Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2012 |
| End Date: | December 2016 |
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.
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.
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.
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.
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
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