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)
- Conditions
- Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
- Interventions
- Drug: BOTOXDrug: Placebo for BOTOX
- Registration Number
- NCT05141006
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 83
- 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.
- History or current diagnosis of Hunner Lesions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. Placebo Placebo for 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. BOTOX BOTOX 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (43)
Alliance for Multispecialty Research (AMR) - Mobile /ID# 241002
🇺🇸Mobile, Alabama, United States
Urology Centers of Alabama /ID# 243600
🇺🇸Homewood, Alabama, United States
Sun Kim Urology /ID# 257566
🇺🇸Buena Park, California, United States
Cedars-Sinai Medical Center /ID# 245786
🇺🇸Los Angeles, California, United States
Urology Associates of Mobile, PA /ID# 255854
🇺🇸Mobile, Alabama, United States
Thomas Jefferson University Hospital /ID# 243703
🇺🇸Philadelphia, Pennsylvania, 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
Clinical Research Center FL /ID# 243961
🇺🇸Pompano Beach, Florida, United States
Advances in Health, Inc. /ID# 240850
🇺🇸Pearland, Texas, United States
Queen's University /ID# 243972
🇨🇦Kingston, Ontario, Canada
Columbia University Medical Center /ID# 241087
🇺🇸New York, New York, United States
Wright State Physicians Obstetrics and Gynecology /ID# 241112
🇺🇸Oakwood, Ohio, United States
Ochsner LSU Health Shreveport - Regional Urology. /ID# 241034
🇺🇸Shreveport, Louisiana, United States
Western New York Urology Associates - Harlem Professional Park /ID# 241036
🇺🇸Cheektowaga, New York, United States
Crystal Run Healthcare - Warwick /ID# 241116
🇺🇸Warwick, New York, United States
Potomac Urology - Alexandria /ID# 243963
🇺🇸Alexandria, Virginia, United States
Univ Hosp Cleveland /ID# 247228
🇺🇸Cleveland, Ohio, United States
MetroHealth Medical Center /ID# 254812
🇺🇸Cleveland, Ohio, United States
The Christ Hospital /ID# 244800
🇺🇸Cincinnati, Ohio, United States
UCSD Medical Center /ID# 244935
🇺🇸San Diego, California, United States
Sheldon Freedman MD, ltd /ID# 241003
🇺🇸Las Vegas, Nevada, United States
Medstar Health Research Institute /ID# 245371
🇺🇸Washington, District of Columbia, United States
Southern Shores Urogynecology /ID# 253316
🇺🇸Myrtle Beach, South Carolina, United States
Chattanooga Research and Medicine /ID# 241092
🇺🇸Chattanooga, Tennessee, United States
CHUS - Hopital Fleurimont /ID# 244058
🇨🇦Sherbrooke, Quebec, Canada
Urology Associates PC - Nashville /ID# 242914
🇺🇸Nashville, Tennessee, United States
Hartford Healthcare Group - Farmington /ID# 241037
🇺🇸Farmington, Connecticut, United States
University of California, Los Angeles /ID# 245131
🇺🇸Los Angeles, California, United States
Inland Urology /ID# 255410
🇺🇸Pomona, California, United States
Prestige Medical Group /ID# 257564
🇺🇸Santa Ana, California, United States
Sunnybrook Health Sciences Ctr /ID# 243243
🇨🇦Toronto, Ontario, Canada
Tri Valley Urology Medical Group /ID# 254918
🇺🇸Murrieta, California, United States
Manatee Medical Research Institute /ID# 243859
🇺🇸Bradenton, Florida, United States
Columbia University Medical Center /ID# 241086
🇺🇸New York, New York, United States
Bay State Clincial Trials, Inc /ID# 240848
🇺🇸Watertown, Massachusetts, United States
University of Texas Southwestern Medical Center /ID# 244931
🇺🇸Dallas, Texas, United States
MidLantic Urology /ID# 240997
🇺🇸Bala-Cynwyd, Pennsylvania, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery - Allentown /ID# 241012
🇺🇸Allentown, Pennsylvania, United States
Urology of Virginia /ID# 240843
🇺🇸Virginia Beach, Virginia, United States
Specialists For Women - Hillpoint /ID# 242541
🇺🇸Suffolk, Virginia, United States
Medical University of South Carolina /ID# 242780
🇺🇸Charleston, South Carolina, United States
Cleveland Clinic Avon Hospital /ID# 247221
🇺🇸Avon, Ohio, United States