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Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)Phase 2IC/BPS POCNCT05141006

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)

A Phase 2 study testing BOTOX in people with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), run by AbbVie at 43 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
BOTOX
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
43 sitesin 2 countries
Study dates
29 Mar 2022to 6 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • History or current diagnosis of Hunner Lesions.

Trial locations and contacts

43 sites in 2 countries.

43 sites in 2 countries

United States40 sites

  • Potomac Urology - Alexandria /ID# 243963

    Alexandria, Virginia, 22311-1735

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

    Allentown, Pennsylvania, 18103-3691

  • Cleveland Clinic Avon Hospital /ID# 247221

    Avon, Ohio, 44011-1172

  • MidLantic Urology /ID# 240997

    Bala-Cynwyd, Pennsylvania, 19004

  • Manatee Medical Research Institute /ID# 243859

    Bradenton, Florida, 34205-8626

  • Sun Kim Urology /ID# 257566

    Buena Park, California, 90621

  • Medical University of South Carolina /ID# 242780

    Charleston, South Carolina, 29425

  • Chattanooga Research and Medicine /ID# 241092

    Chattanooga, Tennessee, 37412-3964

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

    Cheektowaga, New York, 14225-2591

  • The Christ Hospital /ID# 244800

    Cincinnati, Ohio, 45219

  • Univ Hosp Cleveland /ID# 247228

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center /ID# 254812

    Cleveland, Ohio, 44109

  • University of Texas Southwestern Medical Center /ID# 244931

    Dallas, Texas, 75390-7208

  • Hartford Healthcare Group - Farmington /ID# 241037

    Farmington, Connecticut, 06032-1943

  • Urology Centers of Alabama /ID# 243600

    Homewood, Alabama, 35209

  • Sheldon Freedman MD, ltd /ID# 241003

    Las Vegas, Nevada, 89144

  • Cedars-Sinai Medical Center /ID# 245786

    Los Angeles, California, 90048

  • University of California, Los Angeles /ID# 245131

    Los Angeles, California, 90095

  • Urology Associates of Mobile, PA /ID# 255854

    Mobile, Alabama, 36608-6705

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

    Mobile, Alabama, 36608

  • Tri Valley Urology Medical Group /ID# 254918

    Murrieta, California, 92562-4902

  • Southern Shores Urogynecology /ID# 253316

    Myrtle Beach, South Carolina, 29752

  • Urology Associates PC - Nashville /ID# 242914

    Nashville, Tennessee, 37209-4035

  • North Shore University Hospital /ID# 242594

    New Hyde Park, New York, 11040

  • NYU Langone Medical Center /ID# 241090

    New York, New York, 10016-6402

  • Columbia University Medical Center /ID# 241086

    New York, New York, 10032-3729

  • Columbia University Medical Center /ID# 241087

    New York, New York, 10032-3729

  • Wright State Physicians Obstetrics and Gynecology /ID# 241112

    Oakwood, Ohio, 45409-1980

  • Advances in Health, Inc. /ID# 240850

    Pearland, Texas, 77854

  • Thomas Jefferson University Hospital /ID# 243703

    Philadelphia, Pennsylvania, 19107

  • Inland Urology /ID# 255410

    Pomona, California, 91767

  • Clinical Research Center FL /ID# 243961

    Pompano Beach, Florida, 33060

  • UCSD Medical Center /ID# 244935

    San Diego, California, 92103-8620

  • Prestige Medical Group /ID# 257564

    Santa Ana, California, 92705

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

    Shreveport, Louisiana, 71106

  • Specialists For Women - Hillpoint /ID# 242541

    Suffolk, Virginia, 23434-7181

  • Urology of Virginia /ID# 240843

    Virginia Beach, Virginia, 23462

  • Crystal Run Healthcare - Warwick /ID# 241116

    Warwick, New York, 10990-4105

  • Medstar Health Research Institute /ID# 245371

    Washington D.C., District of Columbia, 20010

  • Bay State Clincial Trials, Inc /ID# 240848

    Watertown, Massachusetts, 01890

Other trials in United States

Canada3 sites

  • Queen's University /ID# 243972

    Kingston, Ontario, K7L 3J7

  • CHUS - Hopital Fleurimont /ID# 244058

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Health Sciences Ctr /ID# 243243

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

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)

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.

Read more

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.

Being tested
BOTOX, Placebo for BOTOX
Keywords
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), BOTOX, Botulinum Toxin Type A, OnabotulinumtoxinA
Medical subject headings
Cystitis, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BOTOXDrug

    Also called OnabotulinumtoxinA, Botulinum Toxin Type A

    Injection into the bladder

  • Placebo for BOTOXDrug

    Injection into the bladder

Study groups in NCT05141006
Study groupRoleWhat they receive
BOTOXExperimentalParticipants 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.
Receives: Drug: BOTOX
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: BOTOX; Drug: Placebo for BOTOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Week 0) to Week 6

Secondary outcomes (3)

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

    Micturition (whether participant was able to urinate) episodes will be collected on the 3-day bladder diary.

    Measured: Baseline (Week 0) to Week 6

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

    Urgency episodes will be reported in the 3-day bladder diary.

    Measured: Baseline (Week 0) to Week 6

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

    Nocturia episodes will be reported in the 3-day bladder diary.

    Measured: Baseline (Week 0) to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2021
  2. Study start29 Mar 2022
  3. Primary completion5 Jul 2024
  4. Study completion6 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05141006
Sponsor's protocol ID
M21-459
Acronym
IC/BPS POC
Status last verified
May 2025
First submitted
19 Nov 2021
Last updated
6 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BOTOX in people with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), run by AbbVie at 43 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Average Daily Worst Bladder Pain (time frame: Baseline (Week 0) to Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05141006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.

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