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)

NCT05141006 | Completed Phase 2 FDA Drug

• 1 other identifier: M21-459
• Study Type: interventional
• Target: 83
• Locations: 2 countries
• Sites: 43

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.

Conditions

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Keywords

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS); BOTOX; Botulinum Toxin Type A; OnabotulinumtoxinA

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Week 0) to Week 6

Secondary Outcomes (3)

• Change in the Average Number of Micturition Episodes per 24-hour Period

  Baseline (Week 0) to Week 6

• Change in the Average Number of Urgency Episodes per 24-hour Period

  Baseline (Week 0) to Week 6

• Change in the Average Number of Nocturia Episodes per 24-hour Period

  Baseline (Week 0) to Week 6

Study Arms (2)

BOTOX

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

BOTOX DRUG

Injection into the bladder

Also known as: OnabotulinumtoxinA, Botulinum Toxin Type A

BOTOX; Placebo

Placebo for BOTOX DRUG

Injection into the bladder

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (43)

Urology Centers of Alabama /ID# 243600

Homewood, Alabama, 35209, United States

Location

Urology Associates of Mobile, PA /ID# 255854

Mobile, Alabama, 36608-6705, United States

Location

Alliance for Multispecialty Research (AMR) - Mobile /ID# 241002

Mobile, Alabama, 36608, United States

Location

Sun Kim Urology /ID# 257566

Buena Park, California, 90621, United States

Location

Cedars-Sinai Medical Center /ID# 245786

Los Angeles, California, 90048, United States

Location

University of California, Los Angeles /ID# 245131

Los Angeles, California, 90095, United States

Location

Tri Valley Urology Medical Group /ID# 254918

Murrieta, California, 92562-4902, United States

Location

Inland Urology /ID# 255410

Pomona, California, 91767, United States

Location

UCSD Medical Center /ID# 244935

San Diego, California, 92103-8620, United States

Location

Prestige Medical Group /ID# 257564

Santa Ana, California, 92705, United States

Location

Hartford Healthcare Group - Farmington /ID# 241037

Farmington, Connecticut, 06032-1943, United States

Location

Medstar Health Research Institute /ID# 245371

Washington D.C., District of Columbia, 20010, United States

Location

Manatee Medical Research Institute /ID# 243859

Bradenton, Florida, 34205-8626, United States

Location

Clinical Research Center FL /ID# 243961

Pompano Beach, Florida, 33060, United States

Location

Ochsner LSU Health Shreveport - Regional Urology. /ID# 241034

Shreveport, Louisiana, 71106, United States

Location

Bay State Clincial Trials, Inc /ID# 240848

Watertown, Massachusetts, 01890, United States

Location

Sheldon Freedman MD, ltd /ID# 241003

Las Vegas, Nevada, 89144, United States

Location

Western New York Urology Associates - Harlem Professional Park /ID# 241036

Cheektowaga, New York, 14225-2591, United States

Location

North Shore University Hospital /ID# 242594

New Hyde Park, New York, 11040, United States

Location

NYU Langone Medical Center /ID# 241090

New York, New York, 10016-6402, United States

Location

Columbia University Medical Center /ID# 241086

New York, New York, 10032-3729, United States

Location

Columbia University Medical Center /ID# 241087

New York, New York, 10032-3729, United States

Location

Crystal Run Healthcare - Warwick /ID# 241116

Warwick, New York, 10990-4105, United States

Location

Cleveland Clinic Avon Hospital /ID# 247221

Avon, Ohio, 44011-1172, United States

Location

The Christ Hospital /ID# 244800

Cincinnati, Ohio, 45219, United States

Location

Univ Hosp Cleveland /ID# 247228

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center /ID# 254812

Cleveland, Ohio, 44109, United States

Location

Wright State Physicians Obstetrics and Gynecology /ID# 241112

Oakwood, Ohio, 45409-1980, United States

Location

The Institute for Female Pelvic Medicine and Reconstructive Surgery - Allentown /ID# 241012

Allentown, Pennsylvania, 18103-3691, United States

Location

MidLantic Urology /ID# 240997

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Thomas Jefferson University Hospital /ID# 243703

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina /ID# 242780

Charleston, South Carolina, 29425, United States

Location

Southern Shores Urogynecology /ID# 253316

Myrtle Beach, South Carolina, 29752, United States

Location

Chattanooga Research and Medicine /ID# 241092

Chattanooga, Tennessee, 37412-3964, United States

Location

Urology Associates PC - Nashville /ID# 242914

Nashville, Tennessee, 37209-4035, United States

Location

University of Texas Southwestern Medical Center /ID# 244931

Dallas, Texas, 75390-7208, United States

Location

Advances in Health, Inc. /ID# 240850

Pearland, Texas, 77854, United States

Location

Potomac Urology - Alexandria /ID# 243963

Alexandria, Virginia, 22311-1735, United States

Location

Specialists For Women - Hillpoint /ID# 242541

Suffolk, Virginia, 23434-7181, United States

Location

Urology of Virginia /ID# 240843

Virginia Beach, Virginia, 23462, United States

Location

Queen's University /ID# 243972

Kingston, Ontario, K7L 3J7, Canada

Location

Sunnybrook Health Sciences Ctr /ID# 243243

Toronto, Ontario, M4N 3M5, Canada

Location

CHUS - Hopital Fleurimont /ID# 244058

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: March 29, 2022
• Primary Completion: July 5, 2024
• Study Completion: December 6, 2024
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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/

Locations

CA (3); US (40)