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)

Completed · Phase 2 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT05141006

Run by

AbbVie

People needed

83

Starts

2022-03-29

Expected to finish

2024-12-06

Last updated by the study team

2025-05-06

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• History or current diagnosis of Hunner Lesions.

Where it is running

• Urology Centers of Alabama /ID# 243600 — Homewood, Alabama, United States
• Urology Associates of Mobile, PA /ID# 255854 — Mobile, Alabama, United States
• Alliance for Multispecialty Research (AMR) - Mobile /ID# 241002 — Mobile, Alabama, United States
• Sun Kim Urology /ID# 257566 — Buena Park, California, United States
• Cedars-Sinai Medical Center /ID# 245786 — Los Angeles, California, United States
• University of California, Los Angeles /ID# 245131 — Los Angeles, California, United States
• Tri Valley Urology Medical Group /ID# 254918 — Murrieta, California, United States
• Inland Urology /ID# 255410 — Pomona, California, United States
• UCSD Medical Center /ID# 244935 — San Diego, California, United States
• Prestige Medical Group /ID# 257564 — Santa Ana, California, United States
• Hartford Healthcare Group - Farmington /ID# 241037 — Farmington, Connecticut, United States
• Medstar Health Research Institute /ID# 245371 — Washington D.C., District of Columbia, United States
• Manatee Medical Research Institute /ID# 243859 — Bradenton, Florida, United States
• Clinical Research Center FL /ID# 243961 — Pompano Beach, Florida, United States
• Ochsner LSU Health Shreveport - Regional Urology. /ID# 241034 — Shreveport, Louisiana, United States
• Bay State Clincial Trials, Inc /ID# 240848 — Watertown, Massachusetts, United States
• Sheldon Freedman MD, ltd /ID# 241003 — Las Vegas, Nevada, United States
• Western New York Urology Associates - Harlem Professional Park /ID# 241036 — Cheektowaga, New York, United States
• North Shore University Hospital /ID# 242594 — New Hyde Park, New York, United States
• NYU Langone Medical Center /ID# 241090 — New York, New York, United States
• Columbia University Medical Center /ID# 241086 — New York, New York, United States
• Columbia University Medical Center /ID# 241087 — New York, New York, United States
• Crystal Run Healthcare - Warwick /ID# 241116 — Warwick, New York, United States
• Cleveland Clinic Avon Hospital /ID# 247221 — Avon, Ohio, United States
• The Christ Hospital /ID# 244800 — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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