Trial Outcomes & Findings for Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) (NCT NCT01731470)

Last Updated: 2017-01-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

4 and 8 weeks post-treatment

Results posted on

2017-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	Liposomes Liposomes Liposomes: Intravesical instillation of liposomes.
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Liposomes Liposomes Liposomes: Intravesical instillation of liposomes.
Overall Study Withdrawal by Subject	1
Overall Study Did not meet study criteria	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liposomes n=16 Participants Liposomes Liposomes: Intravesical instillation of liposomes.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Gender Female	13 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 and 8 weeks post-treatment

Outcome measures

Outcome measures
Measure	Liposomes n=14 Participants Liposomes Liposomes: Intravesical instillation of liposomes.
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 Baseline to 4 Weeks Post Treatment	-4 units on a scale Interval -7.0 to -1.0
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 Baseline to 8 Weeks Post Treatment	-4 units on a scale Interval -8.0 to -1.0

SECONDARY outcome

Timeframe: 4 and 8 weeks post-treatment

Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.

Outcome measures

Outcome measures
Measure	Liposomes n=14 Participants Liposomes Liposomes: Intravesical instillation of liposomes.
Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS) Baseline to 4 Weeks Post	-2 units on a scale Interval -3.82 to 0.0
Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS) Baseline to 8 Weeks Post-Treatment	-1.14 units on a scale Interval -3.9 to -0.9

Adverse Events

Liposomes

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Liposomes n=14 participants at risk Liposomes Liposomes: Intravesical instillation of liposomes.
Renal and urinary disorders Hematuria	7.1% 1/14 • Number of events 1 • Adverse event data were collected for approximately 12 weeks, from the first treatment visit through 8 weeks post-treatment.
Gastrointestinal disorders Irritable Bowel	7.1% 1/14 • Number of events 1 • Adverse event data were collected for approximately 12 weeks, from the first treatment visit through 8 weeks post-treatment.
Musculoskeletal and connective tissue disorders Muscle Pull	7.1% 1/14 • Number of events 1 • Adverse event data were collected for approximately 12 weeks, from the first treatment visit through 8 weeks post-treatment.
Renal and urinary disorders Infection	7.1% 1/14 • Number of events 2 • Adverse event data were collected for approximately 12 weeks, from the first treatment visit through 8 weeks post-treatment.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • Adverse event data were collected for approximately 12 weeks, from the first treatment visit through 8 weeks post-treatment.
Musculoskeletal and connective tissue disorders Pinched Nerve	7.1% 1/14 • Number of events 1 • Adverse event data were collected for approximately 12 weeks, from the first treatment visit through 8 weeks post-treatment.
Musculoskeletal and connective tissue disorders Fracture	7.1% 1/14 • Number of events 1 • Adverse event data were collected for approximately 12 weeks, from the first treatment visit through 8 weeks post-treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia	7.1% 1/14 • Number of events 1 • Adverse event data were collected for approximately 12 weeks, from the first treatment visit through 8 weeks post-treatment.

Additional Information

Kenneth Peters MD

Beaumont Hospital, Royal Oak

Phone: 248-551-0387

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place