Interstitial Cystitis
Conditions
Brief summary
The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.
Detailed description
The study is conducted in 2 parts - a randomized, blinded part in which patients are randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo (LiRIS with inactive substance) or Sham(Insertion procedure only with neither LiRIS nor LiRIS Placebo), followed by an open extension part in which all patients are assigned to receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to Sham). All patients who complete part 1 of the study have the option to enter the extension.
Interventions
DRUGLidocaine Releasing Intravesical System - LiRIS®
Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.
OTHERLiRIS Placebo
LiRIS Placebo contains inactive substance only; LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.
PROCEDURESham Cystoscopy Procedure
Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.
Sponsors
TARIS Biomedical, Inc.
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women age 18 and over * Diagnosed with Interstitial Cystitis as defined by protocol * Able and willing to complete questionnaires and diary * Able to comply with visit schedule including Day 14 Removal visit * Completion of blinded study prior to enrolling in unblinded part of study
Exclusion criteria
* Pregnant or lactating women * Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product * History or presence of any condition that would make it difficult to evaluate symptoms * Did not complete blinded study (unblinded part of study only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7 | Baseline, Day 7 | Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement. |
| Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14 | Baseline, Day 14 | Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement. |
| Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28 | Baseline, Day 28 | Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement. |
| Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42 | Baseline, Day 42 | Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score | Baseline, Days 7, 14, 28 and 42 | Participants answered four questions about how bothersome their symptoms were over the past month using a 5 point scale: 1=No problem to 4=Big problem for a total possible score of 0 (best) to 16 worst). A negative change from Baseline indicates improvement. |
| Percentage of Responders Using the Global Response Assessment (GRA) | Baseline, Days 7, 14, 28 and 42 | Participants assessed their response to treatment using a seven item scale from Markedly improved to Markedly worse. A responder was defined as a participant who rated their symptoms as either Moderately or Markedly improved. |
| Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Baseline, Day 14 | Cystoscopic examinations were performed at Baseline and Day 14. The investigator assessed the urethra and bladder for the following: visibility of ureters, stricture, erythema, presence and number of Hunner's lesion(s) and the extent of erythema. For sites with the capability, videography or high resolution digital photographs of the bladder were taken. The findings at Day 14 were compared to the findings at Baseline and were reported as Improvement, Worsening or No Change. |
| Change From Baseline in Urinary Urgency as Assessed by VAS | Baseline, Days 7, 14, 28 and 42 | Urinary urgency was defined as an immediate unstoppable urge to urinate which may be due to a sudden involuntary contraction of the muscular wall of the bladder and may be accompanied by discomfort in the bladder. Participants reported symptom of urinary urgency in the last 24 hours using a Urgency Visual Analogue Scale (VAS). The Urgency VAS consists of a 10 centimeter (cm) horizontal line with the words No Urgency (best) at the left end (0 cm) and the words Urgency as bad as you can imagine (worst) at the right end (10 cm). Participants were instructed to complete the Pain VAS by marking the spot on the line that corresponded to their urinary urgency. A negative change from Baseline indicates improvement. |
| Change From Baseline in Voiding Frequency | Baseline, Days 7, 14, 28 and 42 | Participants recorded Voiding Frequency in a 72 hour voiding log at Day 7, 14, 28 and 42. Lower numbers of voiding frequency is the best. A negative change from Baseline indicates improvement. |
| Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Baseline, Days 7, 14, 28 and 42 | Participants answered four questions about bladder/voiding symptoms over the past month. 2 questions were on a scale of 0=Not at all to 5=Almost always, 1 question on a scale of 0=Not at all to 5=5 or more times per night and 1 questions from 0=Not at all to 4=Almost always for a total possible score of 0 (best) to19 (worst). A negative change from Baseline indicates improvement |
Countries
Canada, United States
Participant flow
Recruitment details
Study subjects were recruited by clinical centers that saw subjects meeting eligibility criteria and were capable of undergoing cystoscopy per protocol specifications. The first subject was enrolled 28 November 2011.
Pre-assignment details
In addition to meeting all protocol defined inclusion/exclusion criteria, participants were required to be females with a confirmed diagnosis of moderate to severe Interstitial Cystitis (IC) according to the 1987 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) symptom severity criteria (modified to exclude cystometry).
Participants by arm
| Arm | Count |
|---|---|
| LiRIS® 400 Mg-Randomized Study LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14. | 47 |
| LiRIS® Placebo-Randomized Study LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14. | 46 |
| Sham Cystoscopic Procedure-Randomized Study Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo. | 11 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Randomized, Blinded Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Randomized, Blinded Study | Withdrawal by Subject | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | LiRIS® 400 Mg-Randomized Study | LiRIS® Placebo-Randomized Study | Sham Cystoscopic Procedure-Randomized Study | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 4 Participants | 7 Participants | 0 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 39 Participants | 11 Participants | 92 Participants |
| Age, Continuous | 44.4 years STANDARD_DEVIATION 14.76 | 45.9 years STANDARD_DEVIATION 15.85 | 38.1 years STANDARD_DEVIATION 12.9 | 44.4 years STANDARD_DEVIATION 15.12 |
| Region of Enrollment Canada | 3 participants | 2 participants | 0 participants | 5 participants |
| Region of Enrollment United States | 44 participants | 44 participants | 11 participants | 99 participants |
| Sex: Female, Male Female | 47 Participants | 46 Participants | 11 Participants | 104 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 23 / 46 | 23 / 46 | 7 / 11 | 29 / 56 |
| serious Total, serious adverse events | 1 / 46 | 2 / 46 | 0 / 11 | 0 / 56 |
Outcome results
Primary
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Time frame: Baseline, Day 14
Population: Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14 | -0.81 centimeters | Standard Deviation 2.5 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14 | -0.45 centimeters | Standard Deviation 2.45 |
Primary
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Time frame: Baseline, Day 42
Population: Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42 | -0.89 centimeters | Standard Deviation 2.58 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42 | -1.40 centimeters | Standard Deviation 2.51 |
Primary
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Time frame: Baseline, Day 7
Population: Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7 | -1.25 centimeters | Standard Deviation 2.45 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7 | -0.84 centimeters | Standard Deviation 1.92 |
Primary
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Time frame: Baseline, Day 28
Population: Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28 | -0.92 centimeters | Standard Deviation 2.36 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28 | -1.36 centimeters | Standard Deviation 2.28 |
Secondary
Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Participants answered four questions about bladder/voiding symptoms over the past month. 2 questions were on a scale of 0=Not at all to 5=Almost always, 1 question on a scale of 0=Not at all to 5=5 or more times per night and 1 questions from 0=Not at all to 4=Almost always for a total possible score of 0 (best) to19 (worst). A negative change from Baseline indicates improvement
Time frame: Baseline, Days 7, 14, 28 and 42
Population: Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiRIS® 400 Mg-Randomized Study | Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Change from Baseline at Day 7 | -2.39 score on a scale | Standard Deviation 3.18 |
| LiRIS® 400 Mg-Randomized Study | Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Change from Baseline at Day 14 | -2.02 score on a scale | Standard Deviation 3.9 |
| LiRIS® 400 Mg-Randomized Study | Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Change from Baseline at Day 28 | -2.93 score on a scale | Standard Deviation 3.83 |
| LiRIS® 400 Mg-Randomized Study | Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Change from Baseline at Day 42 | -2.83 score on a scale | Standard Deviation 4.11 |
| LiRIS® Placebo-Randomized Study | Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Change from Baseline at Day 42 | -2.32 score on a scale | Standard Deviation 3.64 |
| LiRIS® Placebo-Randomized Study | Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Change from Baseline at Day 7 | -2.00 score on a scale | Standard Deviation 3.56 |
| LiRIS® Placebo-Randomized Study | Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Change from Baseline at Day 28 | -2.87 score on a scale | Standard Deviation 3.68 |
| LiRIS® Placebo-Randomized Study | Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Change from Baseline at Day 14 | -1.97 score on a scale | Standard Deviation 3.82 |
Secondary
Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score
Participants answered four questions about how bothersome their symptoms were over the past month using a 5 point scale: 1=No problem to 4=Big problem for a total possible score of 0 (best) to 16 worst). A negative change from Baseline indicates improvement.
Time frame: Baseline, Days 7, 14, 28 and 42
Population: Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score | Change from Baseline at Day 7 | -2.24 score on a scale | Standard Deviation 2.74 |
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score | Change from Baseline at Day 14 | -2.33 score on a scale | Standard Deviation 2.92 |
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score | Change from Baseline at Day 28 | -2.98 score on a scale | Standard Deviation 3.14 |
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score | Change from Baseline at Day 42 | -2.48 score on a scale | Standard Deviation 3.09 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score | Change from Baseline at Day 42 | -1.58 score on a scale | Standard Deviation 3.01 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score | Change from Baseline at Day 7 | -1.54 score on a scale | Standard Deviation 2.97 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score | Change from Baseline at Day 28 | -2.23 score on a scale | Standard Deviation 3.26 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score | Change from Baseline at Day 14 | -1.62 score on a scale | Standard Deviation 3.21 |
Secondary
Change From Baseline in Urinary Urgency as Assessed by VAS
Urinary urgency was defined as an immediate unstoppable urge to urinate which may be due to a sudden involuntary contraction of the muscular wall of the bladder and may be accompanied by discomfort in the bladder. Participants reported symptom of urinary urgency in the last 24 hours using a Urgency Visual Analogue Scale (VAS). The Urgency VAS consists of a 10 centimeter (cm) horizontal line with the words No Urgency (best) at the left end (0 cm) and the words Urgency as bad as you can imagine (worst) at the right end (10 cm). Participants were instructed to complete the Pain VAS by marking the spot on the line that corresponded to their urinary urgency. A negative change from Baseline indicates improvement.
Time frame: Baseline, Days 7, 14, 28 and 42
Population: Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Urinary Urgency as Assessed by VAS | Change from Baseline at Day 7 | 0.66 centimeters | Standard Deviation 2.66 |
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Urinary Urgency as Assessed by VAS | Change from Baseline at Day 14 | -0.76 centimeters | Standard Deviation 3.14 |
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Urinary Urgency as Assessed by VAS | Change from Baseline at Day 28 | -1.01 centimeters | Standard Deviation 2.93 |
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Urinary Urgency as Assessed by VAS | Change from Baseline at Day 42 | -0.30 centimeters | Standard Deviation 2.01 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Urinary Urgency as Assessed by VAS | Change from Baseline at Day 42 | -0.84 centimeters | Standard Deviation 2.74 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Urinary Urgency as Assessed by VAS | Change from Baseline at Day 7 | -1.45 centimeters | Standard Deviation 2.69 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Urinary Urgency as Assessed by VAS | Change from Baseline at Day 28 | -1.77 centimeters | Standard Deviation 2.7 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Urinary Urgency as Assessed by VAS | Change from Baseline at Day 14 | -1.00 centimeters | Standard Deviation 2.74 |
Secondary
Change From Baseline in Voiding Frequency
Participants recorded Voiding Frequency in a 72 hour voiding log at Day 7, 14, 28 and 42. Lower numbers of voiding frequency is the best. A negative change from Baseline indicates improvement.
Time frame: Baseline, Days 7, 14, 28 and 42
Population: Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Voiding Frequency | Change from Baseline at Day 7 | -7.3 Voids | Standard Deviation 12.6 |
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Voiding Frequency | Change from Baseline at Day 28 | -9.3 Voids | Standard Deviation 15.9 |
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Voiding Frequency | Change from Baseline at Day 42 | -9.8 Voids | Standard Deviation 15.3 |
| LiRIS® 400 Mg-Randomized Study | Change From Baseline in Voiding Frequency | Change from Baseline at Day 14 | -8.8 Voids | Standard Deviation 13.2 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Voiding Frequency | Change from Baseline at Day 42 | -7.2 Voids | Standard Deviation 13.2 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Voiding Frequency | Change from Baseline at Day 7 | -1.1 Voids | Standard Deviation 20.3 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Voiding Frequency | Change from Baseline at Day 14 | -5.8 Voids | Standard Deviation 13.1 |
| LiRIS® Placebo-Randomized Study | Change From Baseline in Voiding Frequency | Change from Baseline at Day 28 | -8.4 Voids | Standard Deviation 12.8 |
Secondary
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings
Cystoscopic examinations were performed at Baseline and Day 14. The investigator assessed the urethra and bladder for the following: visibility of ureters, stricture, erythema, presence and number of Hunner's lesion(s) and the extent of erythema. For sites with the capability, videography or high resolution digital photographs of the bladder were taken. The findings at Day 14 were compared to the findings at Baseline and were reported as Improvement, Worsening or No Change.
Time frame: Baseline, Day 14
Population: Intent-to-treat population included all enrolled participants for whom the study insertion procedure on Baseline Randomized was initiated. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LiRIS® 400 Mg-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Bladder Mucosal Erythema:Improvement | 35 percentage of participants |
| LiRIS® 400 Mg-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Bladder Mucosal Erythema:Worsening | 13 percentage of participants |
| LiRIS® 400 Mg-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Bladder Mucosal Erythema:No Change | 50 percentage of participants |
| LiRIS® 400 Mg-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Bladder Mucosal Erythema:Not Done | 2 percentage of participants |
| LiRIS® 400 Mg-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Hunner's Lesions:Improvement | 2 percentage of participants |
| LiRIS® 400 Mg-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Hunner's Lesions:Worsening | 2 percentage of participants |
| LiRIS® 400 Mg-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Hunner's Lesions:No Change | 96 percentage of participants |
| LiRIS® 400 Mg-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Stricture:Improvement | 0 percentage of participants |
| LiRIS® 400 Mg-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Stricture:Worsening | 0 percentage of participants |
| LiRIS® 400 Mg-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Stricture:No Change | 100 percentage of participants |
| LiRIS® Placebo-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Stricture:Improvement | 0 percentage of participants |
| LiRIS® Placebo-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Bladder Mucosal Erythema:Improvement | 15 percentage of participants |
| LiRIS® Placebo-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Hunner's Lesions:Worsening | 2 percentage of participants |
| LiRIS® Placebo-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Bladder Mucosal Erythema:Worsening | 11 percentage of participants |
| LiRIS® Placebo-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Stricture:No Change | 100 percentage of participants |
| LiRIS® Placebo-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Bladder Mucosal Erythema:No Change | 70 percentage of participants |
| LiRIS® Placebo-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Hunner's Lesions:No Change | 89 percentage of participants |
| LiRIS® Placebo-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Bladder Mucosal Erythema:Not Done | 4 percentage of participants |
| LiRIS® Placebo-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Stricture:Worsening | 0 percentage of participants |
| LiRIS® Placebo-Randomized Study | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Hunner's Lesions:Improvement | 9 percentage of participants |
Secondary
Percentage of Responders Using the Global Response Assessment (GRA)
Participants assessed their response to treatment using a seven item scale from Markedly improved to Markedly worse. A responder was defined as a participant who rated their symptoms as either Moderately or Markedly improved.
Time frame: Baseline, Days 7, 14, 28 and 42
Population: Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LiRIS® 400 Mg-Randomized Study | Percentage of Responders Using the Global Response Assessment (GRA) | Day 7 | 24 Percentage of Responders |
| LiRIS® 400 Mg-Randomized Study | Percentage of Responders Using the Global Response Assessment (GRA) | Day 14 | 17 Percentage of Responders |
| LiRIS® 400 Mg-Randomized Study | Percentage of Responders Using the Global Response Assessment (GRA) | Day 28 | 7 Percentage of Responders |
| LiRIS® 400 Mg-Randomized Study | Percentage of Responders Using the Global Response Assessment (GRA) | Day 42 | 12 Percentage of Responders |
| LiRIS® Placebo-Randomized Study | Percentage of Responders Using the Global Response Assessment (GRA) | Day 42 | 21 Percentage of Responders |
| LiRIS® Placebo-Randomized Study | Percentage of Responders Using the Global Response Assessment (GRA) | Day 7 | 18 Percentage of Responders |
| LiRIS® Placebo-Randomized Study | Percentage of Responders Using the Global Response Assessment (GRA) | Day 28 | 25 Percentage of Responders |
| LiRIS® Placebo-Randomized Study | Percentage of Responders Using the Global Response Assessment (GRA) | Day 14 | 20 Percentage of Responders |