A Phase 2 interventional study of BOTOX and Placebo for BOTOX in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), sponsored by AbbVie. Completed at 43 sites in 2 countries. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
227 studies on the registry are indexed under Cystitis, Interstitial; 32 are open to participants now.
This study's enrollment of 83 is above the median of 50 across 152 interventional studies indexed under Cystitis, Interstitial.
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Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
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- 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.
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
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 · Drug: Placebo for BOTOX
Injection into the bladder
Also known as: OnabotulinumtoxinA, Botulinum Toxin Type A
Injection into the bladder
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.
Time frame: Baseline (Week 0) to Week 6
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Week 0) to Week 6
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A