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Intravesical Liposomes for Ulcerative Cystitis

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ClinicalTrials.gov Identifier: NCT01083979
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Interstitial Cystitis
Intervention Drug: Liposomes
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liposomes
Hide Arm/Group Description Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Liposomes
Hide Arm/Group Description Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Change in Symptom and Problem Severity
Hide Description 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
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liposomes
Hide Arm/Group Description:
Intravesical instillation of Liposomes in sterile water totalling 40 cc at four weekly treatments.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: units on a scale
Baseline Total ICSI-PI Score 22
12 Week Total ICSI-PI Score 13
2.Secondary Outcome
Title Bladder Appearance
Hide Description The secondary objective to assess treatment efficacy will compare the number of bladder ulcers pre-treatment to the number of ulcers visualized at 12 weeks, the end of the study.
Time Frame Baseline to 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liposomes
Hide Arm/Group Description:
Intravesical instillation of Liposomes in sterile water totalling 40 cc at four weekly treatments.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Ulcers
Total Number of Ulcers at Baseline 3
Total Number of Ulcers at 12 Weeks 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liposomes
Hide Arm/Group Description Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
All-Cause Mortality
Liposomes
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Liposomes
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Liposomes
Affected / at Risk (%)
Total   0/1 (0.00%) 
This was a single-subject treatment study. Therefore the data analysis and results are limited and are not generalizable.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kenneth M. Peters, MD
Organization: William Beaumont Hospital
Phone: 248-551-0387
Responsible Party: Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01083979     History of Changes
Other Study ID Numbers: 2010-021
First Submitted: March 8, 2010
First Posted: March 10, 2010
Results First Submitted: December 24, 2013
Results First Posted: February 8, 2017
Last Update Posted: February 8, 2017