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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOTOX | Drug | Injection into the bladder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Week 0) to Week 6 |
| Change in the Average Number of Urgency Episodes per 24-hour Period |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers of Alabama /ID# 243600 | Homewood | Alabama | 35209 | United States | ||
| Urology Associates of Mobile, PA /ID# 255854 |
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| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. | View source |
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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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Placebo for BOTOX | Drug | Injection into the bladder |
|
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 | Nocturia episodes will be reported in the 3-day bladder diary. | Baseline (Week 0) to Week 6 |
| Mobile |
| Alabama |
| 36608-6705 |
| United States |
| Alliance for Multispecialty Research (AMR) - Mobile /ID# 241002 | Mobile | Alabama | 36608 | United States |
| Sun Kim Urology /ID# 257566 | Buena Park | California | 90621 | United States |
| Cedars-Sinai Medical Center /ID# 245786 | Los Angeles | California | 90048 | United States |
| University of California, Los Angeles /ID# 245131 | Los Angeles | California | 90095 | United States |
| Tri Valley Urology Medical Group /ID# 254918 | Murrieta | California | 92562-4902 | United States |
| Inland Urology /ID# 255410 | Pomona | California | 91767 | United States |
| UCSD Medical Center /ID# 244935 | San Diego | California | 92103-8620 | United States |
| Prestige Medical Group /ID# 257564 | Santa Ana | California | 92705 | United States |
| Hartford Healthcare Group - Farmington /ID# 241037 | Farmington | Connecticut | 06032-1943 | United States |
| Medstar Health Research Institute /ID# 245371 | Washington D.C. | District of Columbia | 20010 | United States |
| Manatee Medical Research Institute /ID# 243859 | Bradenton | Florida | 34205-8626 | United States |
| Clinical Research Center FL /ID# 243961 | Pompano Beach | Florida | 33060 | United States |
| Ochsner LSU Health Shreveport - Regional Urology. /ID# 241034 | Shreveport | Louisiana | 71106 | United States |
| Bay State Clincial Trials, Inc /ID# 240848 | Watertown | Massachusetts | 01890 | United States |
| Sheldon Freedman MD, ltd /ID# 241003 | Las Vegas | Nevada | 89144 | United States |
| Western New York Urology Associates - Harlem Professional Park /ID# 241036 | Cheektowaga | New York | 14225-2591 | United States |
| North Shore University Hospital /ID# 242594 | New Hyde Park | New York | 11040 | United States |
| NYU Langone Medical Center /ID# 241090 | New York | New York | 10016-6402 | United States |
| Columbia University Medical Center /ID# 241086 | New York | New York | 10032-3729 | United States |
| Columbia University Medical Center /ID# 241087 | New York | New York | 10032-3729 | United States |
| Crystal Run Healthcare - Warwick /ID# 241116 | Warwick | New York | 10990-4105 | United States |
| Cleveland Clinic Avon Hospital /ID# 247221 | Avon | Ohio | 44011-1172 | United States |
| The Christ Hospital /ID# 244800 | Cincinnati | Ohio | 45219 | United States |
| Univ Hosp Cleveland /ID# 247228 | Cleveland | Ohio | 44106 | United States |
| MetroHealth Medical Center /ID# 254812 | Cleveland | Ohio | 44109 | United States |
| Wright State Physicians Obstetrics and Gynecology /ID# 241112 | Oakwood | Ohio | 45409-1980 | United States |
| The Institute for Female Pelvic Medicine and Reconstructive Surgery - Allentown /ID# 241012 | Allentown | Pennsylvania | 18103-3691 | United States |
| MidLantic Urology /ID# 240997 | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Thomas Jefferson University Hospital /ID# 243703 | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina /ID# 242780 | Charleston | South Carolina | 29425 | United States |
| Southern Shores Urogynecology /ID# 253316 | Myrtle Beach | South Carolina | 29752 | United States |
| Chattanooga Research and Medicine /ID# 241092 | Chattanooga | Tennessee | 37412-3964 | United States |
| Urology Associates PC - Nashville /ID# 242914 | Nashville | Tennessee | 37209-4035 | United States |
| University of Texas Southwestern Medical Center /ID# 244931 | Dallas | Texas | 75390-7208 | United States |
| Advances in Health, Inc. /ID# 240850 | Pearland | Texas | 77854 | United States |
| Potomac Urology - Alexandria /ID# 243963 | Alexandria | Virginia | 22311-1735 | United States |
| Specialists For Women - Hillpoint /ID# 242541 | Suffolk | Virginia | 23434-7181 | United States |
| Urology of Virginia /ID# 240843 | Virginia Beach | Virginia | 23462 | United States |
| Queen's University /ID# 243972 | Kingston | Ontario | K7L 3J7 | Canada |
| Sunnybrook Health Sciences Ctr /ID# 243243 | Toronto | Ontario | M4N 3M5 | Canada |
| CHUS - Hopital Fleurimont /ID# 244058 | Sherbrooke | Quebec | J1H 5N4 | Canada |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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