Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Conditions
Keywords
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), BOTOX, Botulinum Toxin Type A, OnabotulinumtoxinA
Brief summary
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.
Interventions
DRUGBOTOX
Injection into the bladder
Injection into the bladder
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Daily Worst Bladder Pain | Baseline (Week 0) to Week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Average Number of Micturition Episodes per 24-hour Period | Baseline (Week 0) to Week 6 | Micturition (whether participant was able to urinate) episodes will be collected on the 3-day bladder diary. |
| Change in the Average Number of Urgency Episodes per 24-hour Period | Baseline (Week 0) to Week 6 | Urgency episodes will be reported in the 3-day bladder diary. |
| Change in the Average Number of Nocturia Episodes per 24-hour Period | Baseline (Week 0) to Week 6 | Nocturia episodes will be reported in the 3-day bladder diary. |
Countries
Canada, United States
Outcome results
None listed