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

NCT ID: NCT01731470

Last Updated: 2017-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-08-31

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.

Conditions

Interstitial Cystitis; Pelvic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liposomes

Liposomes

Group Type: EXPERIMENTAL

Liposomes

Intervention Type: BIOLOGICAL

Intravesical instillation of liposomes.

Interventions

Liposomes

Intravesical instillation of liposomes.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: collaborator

Kenneth Peters, MD

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Peters, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kenneth M Peters, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

William Beaumont Hospital

Royal Oak, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25209396 (View on PubMed)

Other Identifiers

2012-024

Identifier Type: -

Identifier Source: org_study_id