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

Pelvic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01731470
• Other study ID #: 2012-024
• Status: Active, not recruiting
• Phase: N/A
• First received: November 15, 2012
• Last updated: November 1, 2015
• Start date: September 2012
• Est. completion date: December 2016

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Pelvic Pain

Intervention

Biological:
• Liposomes
Intravesical instillation of liposomes.

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Kenneth Peters, MD	William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

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