Study of BOTOX Injections to Assess Change in Disease Activity and Adverse Events in Adult Female Participants With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Study Overview
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Brief Summary
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Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological complex of disorders characterized by symptoms of bladder pain or discomfort, mostly upon bladder filling, and often accompanied by lower urinary tract symptoms (LUTS). This study will assess how safe and effective BOTOX (onabotulinumtoxinA) is in treating IC/BPS. Adverse events and change in disease symptoms will be evaluated. BOTOX (onabotulinumtoxinA) is an investigational drug being developed for the treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Study doctors randomly assign the participants to 1 of 2 groups, called treatment arms, to receive BOTOX or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 80 female participants, aged 18 to 75 years, with a diagnosis of IC/BPS will be enrolled in approximately 40 sites in the United States and Canada. Participants will receive BOTOX or placebo injected into the bladder on Day 1 and will be followed for at least 12 weeks in treatment 1. Eligible participants may request additional dose of BOTOX between Weeks 12 and 24, and will be followed for 12 weeks in treatment period 2. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Arm Study to Assess the Safety and Efficacy of a Single Treatment of BOTOX, Followed by an Optional Open-Label Treatment With BOTOX, in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Conditions
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Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Intervention / Treatment
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* Drug: BOTOX
* Drug: Placebo for BOTOX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Presence of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms for at least 6 months, diagnosed by the investigator as IC/BPS, and confirmed dominant bladder derived pain. Exclusion Criteria: - History or current diagnosis of Hunner Lesions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOTOX<br>Participants will receive BOTOX on Day 1 and will be followed for at least 12 weeks in treatment period 1. An optional dose of BOTOX in Treatment 2 can be requested between Weeks 12 and 24. | Drug: BOTOX<br>* Injection into the bladder<br>* Other names: Botulinum Toxin Type A;|
| Placebo Comparator: Placebo<br>Participants will receive placebo on Day 1 and will be followed for at least 12 weeks in treatment period 1. An optional dose of BOTOX in Treatment 2 can be requested between Weeks 12 and 24. | Drug: BOTOX<br>* Injection into the bladder<br>* Other names: Botulinum Toxin Type A;Drug: Placebo for BOTOX<br>* Injection into the bladder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Daily Worst Bladder Pain | Daily worst bladder pain will be assessed on the 11-point (0-10) numeric rating scale where 0 = no pain and 10 = the worst pain possible. | Baseline (Week 0) to Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Average Number of Micturition Episodes per 24-hour Period | Micturition (whether participant was able to urinate) episodes will be collected on the 3-day bladder diary. | Baseline (Week 0) to Week 6 | 
| Change in the Average Number of Urgency Episodes per 24-hour Period | Urgency episodes will be reported in the 3-day bladder diary. | Baseline (Week 0) to Week 6 | 
| Change in the Average Number of Nocturia Episodes per 24-hour Period | Nocturia episodes will be reported in the 3-day bladder diary. | Baseline (Week 0) to Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), OnabotulinumtoxinA, Botulinum Toxin Type A, BOTOX