Trial Outcomes & Findings for Intravesical Liposomes for Ulcerative Cystitis (NCT NCT01083979)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

Baseline to 12 weeks

Results posted on

2017-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Liposomes Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intravesical Liposomes for Ulcerative Cystitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liposomes n=1 Participants Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Gender Female	1 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

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

Outcome measures

Outcome measures
Measure	Liposomes n=1 Participants Intravesical instillation of Liposomes in sterile water totalling 40 cc at four weekly treatments.
Change in Symptom and Problem Severity 12 Week Total ICSI-PI Score	13 units on a scale
Change in Symptom and Problem Severity Baseline Total ICSI-PI Score	22 units on a scale

SECONDARY outcome

Timeframe: Baseline to 12 Weeks

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.

Outcome measures

Outcome measures
Measure	Liposomes n=1 Participants Intravesical instillation of Liposomes in sterile water totalling 40 cc at four weekly treatments.
Bladder Appearance Total Number of Ulcers at Baseline	3 Ulcers
Bladder Appearance Total Number of Ulcers at 12 Weeks	0 Ulcers

Adverse Events

Liposomes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kenneth M. Peters, MD

William Beaumont Hospital

Phone: 248-551-0387

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place