A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02395042
• Collaborator: (none)
• Enrollment: 59
• Locations: 19
• Arms: 3
• Actual Duration (Months): 31.2
• Patients Per Site: 3.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.

Condition or Disease	Intervention/Treatment	Phase
Cystitis, Interstitial; Ulcer	Drug: LiRIS®; Drug: LiRIS Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study, Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis With Hunner's Lesions
• Actual Study Start Date: Apr 15, 2015
• Actual Primary Completion Date: Jun 29, 2017
• Actual Study Completion Date: Nov 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) Treatment 1 Period (Tx 1): Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period (Tx 2): optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.	Drug: LiRIS®; LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.
Experimental: LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.	Drug: LiRIS®; LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.; Drug: LiRIS Placebo; LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy
Experimental: LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.	Drug: LiRIS®; LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.; Drug: LiRIS Placebo; LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS) [Baseline (Day -7 to Day 0) to Week 4]

   The participant recorded their daily bladder pain score over the previous 24-hour period on a 7-day pain assessment tool as measured by an NRS on an 11-point scale where 0=no pain to 10=worst pain imaginable. The daily pain scores over the 7-day period were averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors was used for analysis.

Secondary Outcome Measures

1. Change From Baseline in the Number of Hunner's Lesions [Baseline (Day 0) to Week 4]

   During each cystoscopy, the investigator counted the number of lesions visible while performing the bladder scan. A negative change from Baseline indicates improvement (less lesions). An ANCOVA model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors was used for analysis.

2. Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions [Baseline (Day 1) to Week 4]

   A standardized video capture protocol for bladder mapping was followed to assess any changes in the number, the size and the severity, of lesions during the study as a result of treatment. A negative change from Baseline indicates improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of interstitial cystitis with Hunner's lesions/ulcers

Exclusion Criteria:

• Previous treatment with LiRIS®

• Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tri Valley Urology Medical Group	Murrieta	California	United States	92562
2	Sutter Institute for Medical Research	Vacaville	California	United States	95688
3	Women's Health Specialty Care	Farmington	Connecticut	United States	06032
4	Atlanta Medical Research Institute	Alpharetta	Georgia	United States	30005
5	Anne Arundel Urology, P.A.	Annapolis	Maryland	United States	21401
6	Chesapeake Urology Research Associates	Baltimore	Maryland	United States	21237
7	Beyer Research	Kalamazoo	Michigan	United States	49009
8	Beaumont Health System	Royal Oak	Michigan	United States	48073
9	Washington University School of Medicine Department of Surgery	Saint Louis	Missouri	United States	63110
10	Western New York Urology Associates, LLC	Cheektowaga	New York	United States	14214
11	McKay Urology	Charlotte	North Carolina	United States	28207
12	Eastern Urological Associates, PA	Greenville	North Carolina	United States	27834
13	Wake Forest Baptist Health	Winston-Salem	North Carolina	United States	27103
14	MetroHealth System/Center for Advanced Gynecology	Cleveland	Ohio	United States	44109
15	Philadelphia Urosurgical Associates	Philadelphia	Pennsylvania	United States	19107
16	University of Washington	Seattle	Washington	United States	98195
17	Aurora Health Care	West Allis	Wisconsin	United States	53227
18	Silverado Research Inc	Victoria	British Columbia	Canada	V8T 2C1
19	Sunnybrook Health Science Centre	Toronto	Ontario	Canada	M4N 3M5

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Till Geib, Allergan

Study Documents (Full-Text)

• Study Protocol - Apr 28, 2016
• Statistical Analysis Plan - Mar 27, 2018

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02395042
• Other Study ID Numbers: 201025-001
• First Posted: Mar 20, 2015
• Last Update Posted: Oct 5, 2018
• Last Verified: Aug 1, 2018

• Additional relevant MeSH terms: Cystitis; Cystitis, Interstitial

Study Results

Participant Flow

Arm/Group Title	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)	LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)	LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Arm/Group Description	Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.	Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.	Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
Period Title: Treatment 1 Period
STARTED	12	31	16
COMPLETED	9	25	14
NOT COMPLETED	3	6	2
Period Title: Treatment 1 Period
STARTED	10	24	13
COMPLETED	9	23	13
NOT COMPLETED	1	1	0

Baseline Characteristics

Arm/Group Title	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)	LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)	LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)	Total
Arm/Group Description	Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.	Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.	Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.	Total of all reporting groups
Overall Participants	12	31	16	59
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.58 (12.09)	57.65 (12.76)	57.31 (14.25)	56.73 (12.93)
Sex: Female, Male (Count of Participants)
Female	12 100%	31 100%	16 100%	59 100%
Male	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	8 66.7%	29 93.5%	16 100%	53 89.8%
Black	3 25%	1 3.2%	0 0%	4 6.8%
Asian	0 0%	1 3.2%	0 0%	1 1.7%
Hispanic	1 8.3%	0 0%	0 0%	1 1.7%
Daily Average Bladder Pain Numeric Rating Scale (NRS) (score on a scale) [Mean (Full Range) ]
Mean (Full Range) [score on a scale]	6.0	5.5	5.6	5.7

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)
Description	The participant recorded their daily bladder pain score over the previous 24-hour period on a 7-day pain assessment tool as measured by an NRS on an 11-point scale where 0=no pain to 10=worst pain imaginable. The daily pain scores over the 7-day period were averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors was used for analysis.
Time Frame	Baseline (Day -7 to Day 0) to Week 4

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with data available for analysis.

Arm/Group Title	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)	LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)	LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Arm/Group Description	Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.	Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.	Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
Measure Participants	9	26	10
Least Squares Mean (90% Confidence Interval) [score on a scale]	-1.6	-2.7	-2.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2), LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.142
	Comments
	Method	ANCOVA
	Comments	ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.15
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2), LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.319
	Comments
	Method	ANCOVA
	Comments	ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.92
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in the Number of Hunner's Lesions
Description	During each cystoscopy, the investigator counted the number of lesions visible while performing the bladder scan. A negative change from Baseline indicates improvement (less lesions). An ANCOVA model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors was used for analysis.
Time Frame	Baseline (Day 0) to Week 4

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with data available for analysis.

Arm/Group Title	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)	LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)	LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Arm/Group Description	Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.	Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.	Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
Measure Participants	8	18	12
Least Squares Mean (90% Confidence Interval) [Hunner's lesions]	0.8	-0.6	-0.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2), LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	ANCOVA
	Comments	ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.46
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2), LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.137
	Comments
	Method	ANCOVA
	Comments	ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.02
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions
Description	A standardized video capture protocol for bladder mapping was followed to assess any changes in the number, the size and the severity, of lesions during the study as a result of treatment. A negative change from Baseline indicates improvement.
Time Frame	Baseline (Day 1) to Week 4

Outcome Measure Data

Analysis Population Description

Data for the planned composite Hunner's Lesions score were supposed to be generated based on digital images by a software algorithm, but the system never worked and no data were generated.

Arm/Group Title	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)	LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)	LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Arm/Group Description	Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.	Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.	Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
Measure Participants	0	0	0

Adverse Events

Time Frame	Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days
Adverse Event Reporting Description	Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of >=5% for the preferred term.
Arm/Group Title	LiRIS Placebo, LiRIS Placebo (Tx 1)		LiRIS®, LiRIS® (Tx 1)		LiRIS Placebo, LiRIS® (Tx 1)		LiRIS Placebo, LiRIS Placebo/LiRIS® (Tx 2)		LiRIS®, LiRIS® /LiRIS® (Tx 2)		LiRIS Placebo, LiRIS /LiRIS® (Tx 2)
Arm/Group Description	Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Adverse events (AEs) reported in Tx 1.		Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. AEs reported in Tx 1.		Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. AEs reported in Tx 1.		Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14. AEs reported in Tx 2.		Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14. AEs reported in Tx 2.		Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14. AEs reported in Tx 2.
All Cause Mortality
	LiRIS Placebo, LiRIS Placebo (Tx 1)		LiRIS®, LiRIS® (Tx 1)		LiRIS Placebo, LiRIS® (Tx 1)		LiRIS Placebo, LiRIS Placebo/LiRIS® (Tx 2)		LiRIS®, LiRIS® /LiRIS® (Tx 2)		LiRIS Placebo, LiRIS /LiRIS® (Tx 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/31 (0%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Serious Adverse Events
	LiRIS Placebo, LiRIS Placebo (Tx 1)		LiRIS®, LiRIS® (Tx 1)		LiRIS Placebo, LiRIS® (Tx 1)		LiRIS Placebo, LiRIS Placebo/LiRIS® (Tx 2)		LiRIS®, LiRIS® /LiRIS® (Tx 2)		LiRIS Placebo, LiRIS /LiRIS® (Tx 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		0/31 (0%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Infections and infestations
Urosepsis	1/12 (8.3%)		0/31 (0%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	LiRIS Placebo, LiRIS Placebo (Tx 1)		LiRIS®, LiRIS® (Tx 1)		LiRIS Placebo, LiRIS® (Tx 1)		LiRIS Placebo, LiRIS Placebo/LiRIS® (Tx 2)		LiRIS®, LiRIS® /LiRIS® (Tx 2)		LiRIS Placebo, LiRIS /LiRIS® (Tx 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/12 (75%)		21/31 (67.7%)		10/16 (62.5%)		4/10 (40%)		2/24 (8.3%)		3/13 (23.1%)
Gastrointestinal disorders
Constipation	0/12 (0%)		1/31 (3.2%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Diarrhoea	1/12 (8.3%)		1/31 (3.2%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Nausea	0/12 (0%)		1/31 (3.2%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Vomiting	1/12 (8.3%)		0/31 (0%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Abdominal pain upper	1/12 (8.3%)		0/31 (0%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Dry mouth	0/12 (0%)		0/31 (0%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Dyspepsia	0/12 (0%)		0/31 (0%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		1/13 (7.7%)
General disorders
Medical device pain	0/12 (0%)		2/31 (6.5%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Suprapubic pain	1/12 (8.3%)		2/31 (6.5%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Fatigue	0/12 (0%)		1/31 (3.2%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Medical device discomfort	0/12 (0%)		2/31 (6.5%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Thirst	0/12 (0%)		0/31 (0%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Infections and infestations
Urinary tract infection	0/12 (0%)		5/31 (16.1%)		2/16 (12.5%)		0/10 (0%)		0/24 (0%)		1/13 (7.7%)
Genital herpes	0/12 (0%)		1/31 (3.2%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Sinusitis	0/12 (0%)		2/31 (6.5%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Herpes virus infection	0/12 (0%)		0/31 (0%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Nasopharyngitis	1/12 (8.3%)		0/31 (0%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Urosepsis	1/12 (8.3%)		0/31 (0%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Genital infection fungal	0/12 (0%)		0/31 (0%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		1/13 (7.7%)
Tooth abscess	0/12 (0%)		0/31 (0%)		0/16 (0%)		1/10 (10%)		0/24 (0%)		0/13 (0%)
Injury, poisoning and procedural complications
Procedural pain	0/12 (0%)		1/31 (3.2%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Arthropod bite	0/12 (0%)		0/31 (0%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Investigations
Liver function test increased	0/12 (0%)		0/31 (0%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		1/13 (7.7%)
Musculoskeletal and connective tissue disorders
Groin pain	0/12 (0%)		0/31 (0%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Nervous system disorders
Dysgeusia	0/12 (0%)		0/31 (0%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Somnolence	0/12 (0%)		0/31 (0%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Headache	0/12 (0%)		0/31 (0%)		0/16 (0%)		1/10 (10%)		0/24 (0%)		0/13 (0%)
Psychiatric disorders
Anxiety	1/12 (8.3%)		0/31 (0%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Depression	0/12 (0%)		0/31 (0%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Renal and urinary disorders
Dysuria	5/12 (41.7%)		6/31 (19.4%)		3/16 (18.8%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Bladder pain	1/12 (8.3%)		3/31 (9.7%)		3/16 (18.8%)		1/10 (10%)		1/24 (4.2%)		0/13 (0%)
Haematuria	0/12 (0%)		4/31 (12.9%)		2/16 (12.5%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Bladder discomfort	0/12 (0%)		4/31 (12.9%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Bladder spasm	0/12 (0%)		1/31 (3.2%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Leukocyturia	1/12 (8.3%)		0/31 (0%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Urethral pain	0/12 (0%)		0/31 (0%)		2/16 (12.5%)		1/10 (10%)		1/24 (4.2%)		0/13 (0%)
Micturition urgency	0/12 (0%)		0/31 (0%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Nephrolithiasis	1/12 (8.3%)		0/31 (0%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Urge incontinence	0/12 (0%)		0/31 (0%)		1/16 (6.3%)		0/10 (0%)		0/24 (0%)		0/13 (0%)
Urinary retention	1/12 (8.3%)		0/31 (0%)		0/16 (0%)		0/10 (0%)		0/24 (0%)		0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.