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)

March 21, 2024 updated by: Allergan

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 3J7
        • Recruiting
        • Queen's University /ID# 243972
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Ctr /ID# 243243
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • CHUS - Hopital Fleurimont /ID# 244058
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Recruiting
        • Urology Centers of Alabama /ID# 243600
      • Mobile, Alabama, United States, 36608
        • Completed
        • Alliance for Multispecialty Research (AMR) - Mobile /ID# 241002
      • Mobile, Alabama, United States, 36608-6705
        • Recruiting
        • Urology Associates of Mobile, PA /ID# 255854
        • Contact:
          • Site Coordinator
          • Phone Number: 251-234-5933
    • California
      • Buena Park, California, United States, 90621
        • Recruiting
        • Sun Kim Urology /ID# 257566
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles /ID# 245131
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center /ID# 245786
      • Murrieta, California, United States, 92562-4902
        • Recruiting
        • Tri Valley Urology Medical Group /ID# 254918
      • Pomona, California, United States, 91767
        • Recruiting
        • Inland Urology /ID# 255410
      • San Diego, California, United States, 92103-8620
        • Recruiting
        • UCSD Medical Center /ID# 244935
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Prestige Medical Group /ID# 257564
    • Connecticut
      • Farmington, Connecticut, United States, 06032-1943
        • Recruiting
        • Hartford Healthcare Group - Farmington /ID# 241037
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Medstar Health Research Institute /ID# 245371
    • Florida
      • Bradenton, Florida, United States, 34205-8626
        • Recruiting
        • Manatee Medical Research Institute /ID# 243859
      • Pompano Beach, Florida, United States, 33060
        • Recruiting
        • Clinical Research Center FL /ID# 243961
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Recruiting
        • Ochsner LSU Health Shreveport - Regional Urology. /ID# 241034
    • Massachusetts
      • Watertown, Massachusetts, United States, 01890
        • Recruiting
        • Bay State Clincial Trials, Inc /ID# 240848
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Sheldon Freedman MD, ltd /ID# 241003
    • New York
      • Cheektowaga, New York, United States, 14225-2591
        • Completed
        • Western New York Urology Associates - Harlem Professional Park /ID# 241036
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • North Shore University Hospital /ID# 242594
      • New York, New York, United States, 10017
        • Recruiting
        • New York University, Langone Health /ID# 241090
      • New York, New York, United States, 10032-3729
        • Recruiting
        • Columbia University Medical Center /ID# 241086
      • New York, New York, United States, 10032-3729
        • Recruiting
        • Columbia University Medical Center /ID# 241087
      • Warwick, New York, United States, 10990-4105
        • Recruiting
        • Crystal Run Healthcare - Warwick /ID# 241116
    • Ohio
      • Avon, Ohio, United States, 44011-1172
        • Recruiting
        • Cleveland Clinic Avon Hospital /ID# 247221
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Christ Hospital /ID# 244800
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Univ Hosp Cleveland /ID# 247228
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth Medical Center /ID# 254812
      • Oakwood, Ohio, United States, 45409-1980
        • Recruiting
        • Wright State Physicians Obstetrics and Gynecology /ID# 241112
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103-3691
        • Recruiting
        • The Institute for Female Pelvic Medicine and Reconstructive Surgery - Allentown /ID# 241012
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Recruiting
        • MidLantic Urology /ID# 240997
      • Philadelphia, Pennsylvania, United States, 19107-4414
        • Recruiting
        • Thomas Jefferson University /ID# 243703
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina /ID# 242780
      • Myrtle Beach, South Carolina, United States, 29752
        • Recruiting
        • Southern Shores Urogynecology /ID# 253316
    • Tennessee
      • Chattanooga, Tennessee, United States, 37412-3964
        • Recruiting
        • Chattanooga Research and Medicine /ID# 241092
      • Nashville, Tennessee, United States, 37209-4035
        • Recruiting
        • Urology Associates PC - Nashville /ID# 242914
    • Texas
      • Dallas, Texas, United States, 75390-7208
        • Recruiting
        • University of Texas Southwestern Medical Center /ID# 244931
      • Pearland, Texas, United States, 77854
        • Recruiting
        • Advances in Health, Inc. /ID# 240850
    • Virginia
      • Alexandria, Virginia, United States, 22311-1735
        • Completed
        • Potomac Urology - Alexandria /ID# 243963
      • Suffolk, Virginia, United States, 23434-7181
        • Completed
        • Specialists For Women - Hillpoint /ID# 242541
      • Virginia Beach, Virginia, United States, 23462
        • Completed
        • Urology of Virginia /ID# 240843

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: BOTOX
Injection into the bladder
Other Names:
  • OnabotulinumtoxinA
  • Botulinum Toxin Type A
Placebo Comparator: Placebo
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
Injection into the bladder
Other Names:
  • OnabotulinumtoxinA
  • Botulinum Toxin Type A
Drug: Placebo for BOTOX
Injection into the bladder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Average Daily Worst Bladder Pain
Time Frame: 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.
Baseline (Week 0) to Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Average Number of Micturition Episodes per 24-hour Period
Time Frame: Baseline (Week 0) to Week 6
Micturition (whether participant was able to urinate) episodes will be collected on the 3-day bladder diary.
Baseline (Week 0) to Week 6
Change in the Average Number of Urgency Episodes per 24-hour Period
Time Frame: Baseline (Week 0) to Week 6
Urgency episodes will be reported in the 3-day bladder diary.
Baseline (Week 0) to Week 6
Change in the Average Number of Nocturia Episodes per 24-hour Period
Time Frame: Baseline (Week 0) to Week 6
Nocturia episodes will be reported in the 3-day bladder diary.
Baseline (Week 0) to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: ALLERGAN INC., Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2022

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

February 4, 2025

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M21-459

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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