Chronic Interstitial Cystitis
Conditions
Keywords
Hunner's lesion
Brief summary
The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.
Interventions
DRUGLiRIS® 400 mg
LiRIS® 400 mg is a drug-device combination product which is placed in the bladder during cystoscopy, remains in the bladder for up to 14 days gradually releasing lidocaine, and removed from the bladder via cystoscopy.
Sponsors
TARIS Biomedical, Inc.
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women age 18 and older * Interstitial Cystitis with history of Hunner's lesions in the bladder * Moderate to severe bladder discomfort * Confirmation of Hunner's lesions in Bladder * Able to report symptom (pain and voiding frequency) in a diary throughout the study
Exclusion criteria
* Pregnant women * History or presence of bladder cancer * History or presence of any condition that would make it difficult to evaluate bladder symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 | Baseline, Day 14 | The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal. |
| Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28 | Baseline, Day 28 | The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR) = presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain | Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12) | Participants rated symptom bladder pain averaged over the previous 3 days using an 11-point numeric rating scale where: 0=no pain to 10=worst pain imaginable. A negative change from Baseline indicates improvement. |
| Change From Baseline in Patient Reported IC Symptom: Daily Total Voids | Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12) | The number of day-time voidings and the number of night-time voidings were averaged over a period of 3 full days and nights. A negative change from Baseline indicates improvement |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LiRIS® 400 mg LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not Complete 4-week Follow-up Visit | 1 |
Baseline characteristics
| Characteristic | LiRIS® 400 mg |
|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 9.16 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14
The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.
Time frame: Baseline, Day 14
Population: Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LiRIS® 400 mg | Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 | Complete Responders | 0.0 percentage of participants |
| LiRIS® 400 mg | Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 | Partial Responders | 85.7 percentage of participants |
| LiRIS® 400 mg | Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 | Stable Disease | 14.3 percentage of participants |
| LiRIS® 400 mg | Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 | Non-Responders | 0.0 percentage of participants |
Primary
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28
The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR) = presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.
Time frame: Baseline, Day 28
Population: Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LiRIS® 400 mg | Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28 | Partial Responders | 100.0 percentage of participants |
| LiRIS® 400 mg | Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28 | Complete Responders | 0.0 percentage of participants |
| LiRIS® 400 mg | Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28 | Stable Disease | 0.0 percentage of participants |
| LiRIS® 400 mg | Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28 | Non-Responders | 0.0 percentage of participants |
Secondary
Change From Baseline in Patient Reported IC Symptom: Daily Total Voids
The number of day-time voidings and the number of night-time voidings were averaged over a period of 3 full days and nights. A negative change from Baseline indicates improvement
Time frame: Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12)
Population: Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. 2 participants did not have data at Week 8 and 12 Follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiRIS® 400 mg | Change From Baseline in Patient Reported IC Symptom: Daily Total Voids | Change from Baseline at Week 2 Follow-up | -4.5 voids | Standard Deviation 4.41 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported IC Symptom: Daily Total Voids | Baseline | 18.2 voids | Standard Deviation 5.74 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported IC Symptom: Daily Total Voids | Change from Baseline at Day 7 | -3.3 voids | Standard Deviation 2.27 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported IC Symptom: Daily Total Voids | Change from Baseline at Day 14 | -3.5 voids | Standard Deviation 3.95 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported IC Symptom: Daily Total Voids | Change from Baseline at Day 20 | -5.7 voids | Standard Deviation 2.18 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported IC Symptom: Daily Total Voids | Change from Baseline at Day 28 | -5.5 voids | Standard Deviation 2.46 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported IC Symptom: Daily Total Voids | Change from Baseline at Week 1 Follow-up | -5.3 voids | Standard Deviation 3.67 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported IC Symptom: Daily Total Voids | Change from Baseline at Week 4 Follow-up | -5.4 voids | Standard Deviation 4.29 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported IC Symptom: Daily Total Voids | Change from Baseline at Week 8 Follow-up (n=5) | -4.9 voids | Standard Deviation 4.42 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported IC Symptom: Daily Total Voids | Change from Baseline at Week 1 Follow-up (n=5) | -3.9 voids | Standard Deviation 4.42 |
Secondary
Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain
Participants rated symptom bladder pain averaged over the previous 3 days using an 11-point numeric rating scale where: 0=no pain to 10=worst pain imaginable. A negative change from Baseline indicates improvement.
Time frame: Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12)
Population: Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. 2 participants did not have data at Week 8 and 12 Follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiRIS® 400 mg | Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain | Baseline | 5.46 score on a scale | Standard Deviation 1.955 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain | Change from Baseline at Day 20 | -4.00 score on a scale | Standard Deviation 2.498 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain | Change from Baseline at Day 28 | -4.27 score on a scale | Standard Deviation 2.411 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain | Change from Baseline at Week 1 Follow-up | -4.11 score on a scale | Standard Deviation 2.753 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain | Change from Baseline at Week 8 Follow-up (n=5) | -3.72 score on a scale | Standard Deviation 3.371 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain | Change from Baseline at Week 12 Follow-up (n=5) | -4.40 score on a scale | Standard Deviation 2.939 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain | Change from Baseline at Day 7 | -1.71 score on a scale | Standard Deviation 1.494 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain | Change from Baseline at Day 14 | -2.97 score on a scale | Standard Deviation 1.739 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain | Change from Baseline at Week 2 Follow-up | -3.70 score on a scale | Standard Deviation 2.922 |
| LiRIS® 400 mg | Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain | Change from Baseline at Week 4 Follow-up | -3.69 score on a scale | Standard Deviation 2.781 |