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

NCT01731470 | Completed Results DMC

• 1 other identifier: 2012-024
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Cystitis; Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score

  The O'Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.

  4 and 8 weeks post-treatment

Secondary Outcomes (1)

• Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)

  4 and 8 weeks post-treatment

Study Arms (1)

Liposomes

EXPERIMENTAL

Liposomes

Biological: Liposomes

Interventions

Liposomes BIOLOGICAL

Intravesical instillation of liposomes.

Liposomes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Kenneth Peters, MD: lead
• Corewell Health East: collaborator

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (1)

• 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.

  PMID: 25209396 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial; Pelvic Pain

Interventions

Liposomes

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials

Limitations and Caveats

This was an open-label trial without evaluation of placebo effects.

Results Point of Contact

• Title: Kenneth Peters MD
• Organization: Beaumont Hospital, Royal Oak

Kenneth.Peters@Beaumont.edu

248-551-0387

Study Officials

• Kenneth M Peters, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 10, 2017
• Results First Posted: January 10, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)