Clinical trial NCT05141006: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Keywords: Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
BOTOX
Botulinum Toxin Type A
OnabotulinumtoxinA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-12-02
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Average Daily Worst Bladder Pain
timeFrame: Baseline (Week 0) to Week 6
Secondary outcomes:
measure: Change in the Average Number of Micturition Episodes per 24-hour Period
timeFrame: Baseline (Week 0) to Week 6
measure: Change in the Average Number of Urgency Episodes per 24-hour Period
timeFrame: Baseline (Week 0) to Week 6
measure: Change in the Average Number of Nocturia Episodes per 24-hour Period
timeFrame: Baseline (Week 0) to Week 6
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama /ID# 243600
state: Alabama
city: Mobile
country: United States
facility: Urology Associates of Mobile, PA /ID# 255854
state: Alabama
city: Mobile
country: United States
facility: Alliance for Multispecialty Research (AMR) - Mobile /ID# 241002
state: Alabama
city: Buena Park
country: United States
facility: Sun Kim Urology /ID# 257566
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center /ID# 245786
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 245131
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group /ID# 254918
state: California
city: Pomona
country: United States
facility: Inland Urology /ID# 255410
state: California
city: San Diego
country: United States
facility: UCSD Medical Center /ID# 244935
state: California
city: Santa Ana
country: United States
facility: Prestige Medical Group /ID# 257564
state: California
city: Farmington
country: United States
facility: Hartford Healthcare Group - Farmington /ID# 241037
state: Connecticut
city: Washington
country: United States
facility: Medstar Health Research Institute /ID# 245371
state: District of Columbia
city: Bradenton
country: United States
facility: Manatee Medical Research Institute /ID# 243859
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center FL /ID# 243961
state: Florida
city: Shreveport
country: United States
facility: Ochsner LSU Health Shreveport - Regional Urology. /ID# 241034
state: Louisiana
city: Watertown
country: United States
facility: Bay State Clincial Trials, Inc /ID# 240848
state: Massachusetts
city: Las Vegas
country: United States
facility: Sheldon Freedman MD, ltd /ID# 241003
state: Nevada
city: Cheektowaga
country: United States
facility: Western New York Urology Associates - Harlem Professional Park /ID# 241036
state: New York
city: New Hyde Park
country: United States
facility: North Shore University Hospital /ID# 242594
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center /ID# 241090
state: New York
city: New York
country: United States
facility: Columbia University Medical Center /ID# 241086
state: New York
city: New York
country: United States
facility: Columbia University Medical Center /ID# 241087
state: New York
city: Warwick
country: United States
facility: Crystal Run Healthcare - Warwick /ID# 241116
state: New York
city: Avon
country: United States
facility: Cleveland Clinic Avon Hospital /ID# 247221
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital /ID# 244800
state: Ohio
city: Cleveland
country: United States
facility: Univ Hosp Cleveland /ID# 247228
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center /ID# 254812
state: Ohio
city: Oakwood
country: United States
facility: Wright State Physicians Obstetrics and Gynecology /ID# 241112
state: Ohio
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery - Allentown /ID# 241012
state: Pennsylvania
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology /ID# 240997
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital /ID# 243703
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 242780
state: South Carolina
city: Myrtle Beach
country: United States
facility: Southern Shores Urogynecology /ID# 253316
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Research and Medicine /ID# 241092
state: Tennessee
city: Nashville
country: United States
facility: Urology Associates PC - Nashville /ID# 242914
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center /ID# 244931
state: Texas
city: Pearland
country: United States
facility: Advances in Health, Inc. /ID# 240850
state: Texas
city: Alexandria
country: United States
facility: Potomac Urology - Alexandria /ID# 243963
state: Virginia
city: Suffolk
country: United States
facility: Specialists For Women - Hillpoint /ID# 242541
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia /ID# 240843
state: Virginia
city: Kingston
country: Canada
facility: Queen's University /ID# 243972
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Ctr /ID# 243243
state: Ontario
city: Sherbrooke
country: Canada
facility: CHUS - Hopital Fleurimont /ID# 244058
state: Quebec
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: