Intravesical Liposomes for Ulcerative Cystitis

NCT01083979 | Completed Results

• 1 other identifier: 2010-021
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to instill liposomes reconstituted with sterile water into the bladder as a compassionate use treatment in one patient with ulcerative interstitial cystitis (IC).

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• Change in Symptom and Problem Severity

  The primary objective is to determine the impact of 4 weekly bladder instillations of liposomes on symptoms in one patient with ulcerative interstitial cystitis (IC). The primary endpoint will be assessed at the end of the study, 8 weeks after the last bladder instillation, and will be measured by the O'Leary-Sant IC Symptom and Problem Indices (ICSI-PI) questionnaire. The ICSI is composed of 4 questions that address the occurrence of IC symptoms, specifically urinary urgency, frequency, nocturia, and bladder pain. Scores range from 0 (Not at All) to 5 (Almost Always). The IC Problem Indices questionnaire is also composed of 4 questions. Each question asks the patient to indicate how big a problem each of the 4 symptoms are to them. Scores range from 0 (No Problem) to 4 (Big Problem). Responses to all 8 questions are added together to create a total ICSI-PI score. The total ICSI-PI scores ranges from 0 to 36. A lower score indicates less IC symptoms and/or related problem

  Baseline to 12 weeks

Secondary Outcomes (1)

• Bladder Appearance

  Baseline to 12 Weeks

Study Arms (1)

Liposomes

EXPERIMENTAL

Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.

Drug: Liposomes

Interventions

Liposomes DRUG

Intravesical instillation

Also known as: Bladder instillation

Liposomes

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ulcerative IC for at least 6 months documented,
• Negative urine cytology,
• Able to independently complete self administered questionnaires and voiding diaries.

You may not qualify if:

• Pregnant or lactating,
• History of bleeding diathesis,
• On anticoagulant therapy,
• Active peptic ulcer disease,
• Obvious neurological impairment,
• Known allergy to liposomes.

Sponsors & Collaborators

• Kenneth Peters, MD: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Liposomes; Administration, Intravesical

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials; Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Limitations and Caveats

This was a single-subject treatment study. Therefore the data analysis and results are limited and are not generalizable.

Results Point of Contact

• Title: Kenneth M. Peters, MD
• Organization: William Beaumont Hospital

kmpeters@beaumont.edu

248-551-0387

Study Officials

• Kenneth M Peters, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: March 8, 2010
• First Posted: March 10, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 8, 2017
• Results First Posted: February 8, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)